home » Control » Business plan for the production of dosage forms. Business plans in medicine and pharmaceuticals

Business plan for the production of dosage forms. Business plans in medicine and pharmaceuticals

I think that many people surfing the Internet, and especially users who are looking for earnings on the Internet, have repeatedly come across such a concept as "pharma" or "".

First of all, let's understand what a pharmacy is. The abbreviation "pharma" comes from the term "pharmaceuticals". According to Ushakov's dictionary, pharmaceutics (Greek Pharmakeutike - medicinal) is a set of applied disciplines about obtaining, processing, storing and dispensing medicines.

That is, in other words, it's all about the pills. And the term “pharma business” that you heard about on the Internet implies the trade in pharmacological preparations (or pharmaceutical preparations, they are simply “pills”).

It turns out that those who are engaged in the pharmaceutical business on the Internet simply sell all kinds of pills.

How is a pharmaceutical business organized on the Internet

Let's start with the fact that there are manufacturers of pharmaceuticals that are located in countries with a low standard of living, and, accordingly, a small salary (for example, in India).

This allows the production of tablets at fairly low prices. However, these are high-quality pharmaceutical products that, due to their low price, are well bought in the US and Europe.

It is because of the low price of pills that such companies can afford to pay good commissions to their distributors. This is very easy to do over the Internet.

An affiliate program is being created in which anyone can take part, just register. Such pharmaceutical affiliate programs offer ready-made online stores for the sale of pills.

You only need to bring customers to your store and receive very good percentage of sales. But bringing in a potential buyer is the hardest part. But we will talk about this in another article in this section.

Who buys pills online

The main part of buyers of tablets through the Internet lives in America and Europe. This is not surprising, they have long understood that buying via the Internet is convenient. And not just pills.

In addition, buying pills on the Internet makes life easier for shy people, they don’t have to “blush” at the pharmacy when buying Viagra or diet pills. They will be brought home. Just as I said above, in an online store the price will be significantly lower than in a regular pharmacy, and this is also not an unimportant plus.

Making money on the farm - why you should try

It is worth trying to make money on pharmaceuticals because it is a big business with a multi-billion dollar turnover. Why not try to grab a piece of this pie for yourself?

Of course, this is not easy - the competition in the topic is decent, however, if you dream of "manna from heaven" while lying on the couch and not making any gestures, you will not have anything.

You have to earn material wealth)) I can say that the most successful adverts (as the participants in affiliate programs are called) earn several thousand dollars a day!

I think that's enough motivation.

3. Overview of affiliate programs for foreign traffic

4. Overview of affiliate programs for Russian traffic
4.1. Affiliate program Rufarma
4.2. DoktorDick Affiliate Program

5. We get Russian pharmaceutical traffic
5.1.

According to The Pharmaceutical Industry and Global Health 2012 report, the development of one new one today costs $1.38 billion and takes 10-15 years. At the same time, they annually spend about $135 billion on research. In recent years, innovations in this complex area have also been actively developing in Russia. The founder and general partner of the California venture company Helix Ventures, who recently became the managing partner of a new player in the venture market - the Russian company RMI Partners, told RBC daily correspondent Elena Krauzova about the prospects for creating innovative drugs in Russia, reforming the domestic pharmaceutical industry and the specifics of "pharmaceutical startups" .

How did you go from a Russian scientist to a venture capitalist in the global pharmaceutical market and a member of the boards of directors of several biomedical companies in Silicon Valley?

Until the 2000s, I was not engaged in business at all, but worked in science. He graduated from a medical university and postgraduate studies, then became a deputy director for science at a research institute that dealt with the problems of the consequences of nuclear tests at the Semipalatinsk test site ... And he got into venture business as a student at Stanford business school. In 2001, I met Pitch Johnson, who is today considered one of the founding fathers of the American venture capital industry. Pitch invited me to his Asset Management Company, where I soon became a partner. I took over the management of several investments already made in portfolio companies, which, with our help, achieved liquidity and were sold to strategic investors.

One of the first such successes, Fusion Biomedical, was sold to Baxter International just 10 months later, recouping our investment by almost 5 times. Then I myself found a few startups that turned out to be interesting. Among them, for example, BiPar Sciences is one of our most successful investments, we sold this company in 2009 for $500 million to Sanofi-Aventis, increasing the initial investment by almost 10 times. In the same year, my partners and I created the management company Helix Ventures, which spun off from Asset Management Company. In general, over the 13 years in this business, I have participated in the investment and development of 27 companies, many of which have already been sold to large players and one has gone public. We expect Helix Ventures portfolio to have a few more exits in the near future.

How noticeable is the implementation of the “course of innovation” announced by the Russian authorities in the domestic pharmaceutical industry?

The Russian pharmaceutical market, on the one hand, is a market for "generics" (cheap analogues of original drugs), which are mostly produced by Russian pharmaceutical companies. On the other hand, this is a market for expensive imported products, a significant part of the proceeds from the sale of which goes to the owners of exclusive rights to these products, who are not at all in Russia. The main feature of the pharmaceutical business is that in the value chain during development, the most profitable links are the very first, i.e. those that just form such exclusive rights. And the task of the state today is to create conditions for the early stages of work on a drug, associated with the creation of intellectual property, to be localized as much as possible in Russia and contribute to the Russian economy.

This is what the Pharma-2020 program is aimed at, which encourages pharmaceutical companies to gradually move from only industrial production of drugs to the development of new drugs. In part, these programs of the Ministry of Industry and Trade also support the transfer of foreign technologies to Russia, which should speed up the access of Russian patients to innovative drugs. However, the most important achievement of these programs should be the creation of an environment for the fact that a significant part of the "added value" was created on the territory of Russia. The very fact of supporting such programs and developments contributes to the development of market mechanisms in the Russian biopharmaceutical industry, despite the fact that the contractual conditions for financing such projects are quite stringent.

What are the main differences between the Russian and American pharmaceutical innovation ecosystems?

An important trend in the global pharmaceutical market in recent years has been the increasing role of small businesses in the creation of new drugs. Large players have significantly less innovative potential and flexibility, prefer to concentrate on production, marketing and sales, therefore, in order to replenish their pipelines, they often do not invest in the early stages of development themselves, but buy young and promising biopharmaceutical startups. This is a positive trend - small companies are more efficient, they spend much less time and money on drug development, they make better use of capital and the infrastructure created by the market. For example, instead of purchasing equipment and reagents themselves, they conduct research - both preclinical (on biological models and laboratory animals) and clinical (testing the safety and efficacy of a new drug in patients), using the capabilities and resources of highly specialized research organizations.

There are many independent companies in the USA that are ready to conduct the tests necessary for a startup - at the highest methodological level, with the fulfillment of all conditions of confidentiality and quality control. Using the services of such companies is much more profitable than creating your own large-scale laboratories. Russian innovative companies do not yet have access to such infrastructure within Russia. I know that some of them use the services of similar service companies in Europe and the USA. It is hardly worth looking at this as a brake on the development of innovations in Russian pharmaceuticals - many American companies, for example, also use R&D services in other countries, but in the absence of such infrastructure centers, potential “added value” undoubtedly flows out of the Russian economy. However, the process of developing and promoting new drugs is now becoming more and more global rather than local: many drugs are invented in one country, tested in another, produced in a third and, ultimately, find consumers all over the planet.

Considering that there are personnel for laboratories in Russia, should the state finance service companies today? Will there be demand for the services of such infrastructure facilities?

It's a difficult question. The development of the biotechnological industry in Russia is many times behind the same IT sphere, where the venture investment environment has already been formed and hundreds of startups have already appeared, found investors and are developing. In the biopharmaceutical industry, the picture is different - the number of pharmaceutical start-ups is small, there is a lack of infrastructure for researchers and insufficient venture capital. And this is, in a sense, a vicious circle: one depends on the other. Indeed, for the functioning of the R&D services industry, a market must also form and mature; there should be a sufficient number of consumers of such services, and so far there are only a few of them. However, if the state wants to spin the flywheel of innovations in pharmaceuticals, it should not be afraid to spend money on creating such infrastructure elements for them. This could spur the emergence of a sufficient number of development companies, which, in turn, would attract the attention of venture investors and increase their interest in this investment sector.

The same applies to venture investment - it is also a service business. However, one must understand that the role of the state in the venture capital market is to launch it, but in no case should it replace private venture capital. Today in Russia there are biotech funds founded with the support of the state development institutions RVC and Rosnano, and their investments have played a key role in the development of the venture capital market. However, now it is important that the ecosystem of innovations gradually become self-sustaining, able to effectively exist without the financial influence of the state. And it is also important to attract not only Russian private investors to this sector, it is also necessary that international institutional investors believe in the profitability of Russian venture funds.

Should the state today finance young companies in the field of biopharmaceuticals, will this not lead to a deformation of the venture capital market?

The problem of Russia today is the too low "birth rate" of small innovative companies in biotech. And the growth of their number is impossible without investment in fundamental science - this is exactly what the state can and should do. The US National Institutes of Health (NIH), for example, spends $25-30 billion annually in grants to support basic research. Smaller, but also quite large amounts, scientists also receive from non-profit organizations. In Russia, no one now supports science on such a large scale - but without this, a sufficient amount of new knowledge and ideas will not be created, from which applied developments with commercial potential can develop in the future.

For the development of this industry, the state can do a lot, also supporting start-ups at the stage of launch and development. Such companies need tax support, incentives, the ability to write off research costs and, most importantly, the ease of going through formal procedures. Startups are sensitive to excessive administrative burdens and the exactingness of corporate law: they do not have a staff of lawyers and accountants to follow complex documentation or communicate with a bunch of audit organizations. So far, such administrative complexities of Russian legislation do not give young development companies the opportunity to concentrate on working on technology. In the US, the legislation is more flexible: for example, registering a company takes 20 minutes, and the entire procedure can be completed without leaving your computer, and a report to the IRS (internal tax service) only needs to be submitted once a year.

By the way, administrative formalities largely limit the ability of startups to participate in the Pharma-2020 program. In order to obtain a contract with a state organization for the development of new drugs (the Ministry of Industry and Trade conducts competitive purchases for such studies), a company sometimes has to provide security in the amount of up to 40% of the original price. Considering the cost of such research, this means that the bidder must withdraw from development programs and freeze $1.5-2 million, which is often beyond the power of a small company, and unacceptable for its investors.

Are Russian scientists less ready to go into business as compared to their Western counterparts?

This is very individual - a scientist may not move from science to business, but simply license his patents. In the US, many developers do not want to leave the walls of the university or laboratory - the transfer of their developments to business is carried out by technology transfer centers created at universities. They know how to competently structure transactions so that a new development can bring profit to the university, the laboratory, and the inventor himself.

Another scenario is also possible - many scientists want to continue working on the molecule they have discovered. Then they move to a newly created company, get a share in the business and continue development in private business. Such a development of events is usually welcomed by investors - after all, intellectual property itself (a patent) often means nothing without its creator, and it is very important for shareholders to get a highly qualified specialist who is also very interested in bringing this intellectual property to a working market product.

In Russia, the mechanism for transferring developments from the university environment to business has not yet been established. Adopted in 2009, the 217th federal law allowed universities to create small innovative enterprises (SIEs) in the form of LLCs, and the non-diluted share of the university in it should be more than a third, or JSC (the share of the university is at least 25%). Unfortunately, private business is not interested in investing in companies with a similar ownership structure. This law is currently being amended to ease these restrictions, but they are still not enough to make this kind of investment attractive.

Is there sufficient access for small companies to finance today in such a capital-intensive industry as biopharmaceuticals?

There is definitely no need to be afraid of the risk of oversaturation of the Russian venture capital market - there is still too little professional venture capital on it. What can not be said, for example, about the United States - the last couple of years there has been a reduction in the amount of capital in the industry. This is due to its excess in the previous decade, which led to a significant erosion of the profitability of the industry as a whole.

What is missing in the Russian venture capital market is the money of institutional investors (both Russian and foreign) who could entrust their funds to venture funds. The speed of this capital coming into the Russian venture capital industry is largely related to the level of professionalism of biotechnology fund managers. Those who lead them today must prove that investments in their funds can be profitable. Since many Russian funds are created with the participation of the state, it is sometimes difficult to do this: state participation implies investment restrictions in terms of belonging to a particular industry, tasks to be solved, or geographically. And this is the main factor in reducing the fund's profitability. Such constraint in decision-making sometimes prevents fund managers from acting on the basis of the main motivating factor - the prospect of obtaining the highest profitability. This ties the hands of venture capitalists and ultimately does not stimulate the influx of new capital into the industry.

The participation of the state in a venture fund as an investor can also stimulate the inflow of private capital, when the state acts as a traditional LP (investor with limited liability in the fund), that is, its role and powers should be equal to all other investors. So, for example, the successful sovereign wealth funds of Singapore and Abu Dhabi are arranged.

It should be noted that the investments of Russian venture funds outside the Russian Federation also work positively for the development of the Russian venture capital industry and increase its profitability. Investors should be able to work with foreign innovations and select deals solely on the basis of their investment potential, not geography, otherwise the Russian venture capital industry will not be able to demonstrate profitability. This is how the history of the industry is built: examples of positive cases, interesting projects and examples of successful investments are accumulated. And this, on the one hand, increases the interest of private investors in such investments, and on the other hand, it forms its own world-class expertise, which is useful for both Russian developers and fund managers. And then the development of the venture industry in the field of biopharmaceutical innovations should in itself become a key factor in the development of all links in the value chain and new products in the biopharmaceutical industry in Russia.

The second stage of the business game (preparatory rehearsal)

General principles of pharmaceutical production organization

The industrial production of medicines is characterized by a high degree of development, since it is based on the widespread use of machines, apparatus, flow mechanized and automated lines. It provides for the mass, serial production of drugs according to standard prescriptions, designed for the average consumer.

For the manufacture of drugs in industrial enterprises, certain conditions are necessary.

1. Mass demand for a medicinal product, which will ensure the profitability of its production.

2. Stability of raw materials and finished product,

since the raw materials for the preparation of medicines in production, as well as the finished product, reach the consumer after a certain period of time spent on their delivery. In addition, it is necessary to have stocks of finished products for timely, uninterrupted satisfaction of demand for it. All this time, the drug should not degrade its quality and lose therapeutic activity. This problem is solved by the introduction of stabilizers, lyophilization, microencapsulation, protective shells, special types of packaging, etc.

3. Standardization of raw materials and drugs to ensure the release of homogeneous products that meet the requirements of regulatory and technical documentation, which is achieved by using modern technology, improving production. The organization of the production of medicines at pharmaceutical enterprises has its own characteristics.

To ensure the high quality of manufactured products and the profitability of production associated with a variety of technological operations, the principle of division of labor is widely used in pharmaceutical enterprises. Enlarged Pharmaceutical

The industrial production consists of a complex of specialized workshops. Workshop - the main production unit of the enterprise, designed to perform homogeneous processes (crushing, extraction, packaging, etc.) or to produce the same type of products (tablet, ampoule, aerosol, etc.). Each workshop has several sections or departments where the same type of operations that make up the technological process are carried out. For example, an ampoule shop has the following sections: glass-blowing, washing, mortar, bottling solutions into ampoules, sealing ampoules, sterilization, etc. The tablet shop includes the following sections: mixing ingredients, granulating, drying the granulate, pressing, etc. With such an organization of production The layout of the workshop sections is of great importance.

The location of the machines must take into account the organization of the production flow, which is one of the decisive conditions for the high-performance work of the workshop. In the ideal case, this is the creation of automated flow lines, which are a contact group of machines, devices that perform all technological operations in sequence with automatic transfer of products along the stream. So, the production line in the ampoule workshop carries out washing of ampoules, filling them with a solution, sealing, checking the sealing quality and purity of the solution in ampoules, etc.

The work of industrial enterprises is characterized by strict regulation and production planning, since a large amount of material is processed and any error in technology can lead to significant material damage and product defects. In order to avoid accidents, the production process is carried out under certain standard conditions, provided for by precise instructions, combined into one consolidated document: the regulation.

1. Production regulations

Regulation (from lat. regulo - to streamline, regulate) is a set of rules that determine the procedure for the activity of a pharmaceutical enterprise for the production of finished products.

The regulation is developed by the research institute or experimental laboratory of the enterprise for each manufactured product on the basis of scientific research. Approved by the director of the enterprise and a higher organization. It gives a characteristic and indicates the amount of raw materials, semi-finished products and

of the finished product, the sequence of stages of the technological process, the mode and time of processing materials by stages, the instrumental scheme, methods of analysis, safety rules and other production conditions. The regulation is the law of production and deviation from it is unacceptable. The implementation of the regulations is monitored by the technical control department (QCD), which has at its disposal a control and analytical laboratory and a staff of inspectors in separate workshops of the plant. Their functions include the control of the production process. In case of deviation from the regulations, the QCD has the right to stop the production process.

2. Basic concepts

Technological the process is a scientifically based set of actions necessary to obtain the finished product. It consists of separate, successive stages of production.

Production stage- this is a link in the technological process, i.e., obtaining an intermediate product (semi-finished product). For example, the process of obtaining tablets includes the following stages: mixing (obtaining complex compositions), granulation, pressing. Each stage, in turn, is a combination of a number of sequential operations.

Technological operation- this is an elementary part of the production process or technological stage, performed at one time by a machine, a separate apparatus or a worker. So, in the production of tablets, technological operations are: grinding individual ingredients, weighing, sifting, moistening the mixture to be granulated, etc.

In pharmaceutical production, the same type of technological (physical) processes are divided into: mechanical, associated with the processing of solid materials, subject to the laws of solid mechanics. These include: grinding, screening, mixing, dosing, pressing; hydromechanical, used for mixing liquids, emulsifying, filtering, screening, centrifuging, cleaning gases from dust, etc.; thermal, obeying the laws of heat transfer. They proceed with a change in the state of aggregation of matter: evaporation, condensation, melting and are associated with heating, cooling, etc.; mass transfer, characterized by the transition of one or more components from one phase to another through their interface by diffusion. These include: solution

substances, crystallization, extraction, rectification, drying, etc. The methods of carrying out these processes determine the efficiency and profitability of production.

According to the nature of the flow, technological processes are divided into periodic, continuous and combined, or semi-continuous.

Periodic processes are carried out in intermittent machines and are stopped from time to time to unload the resulting product and load a new portion of raw materials.

Continuous processes are characterized by the simultaneous receipt of raw materials and unloading of the finished product.

Combined are batch processes in which one or more steps are continuous, such as the compression step in tableting.

The raw materials entering production for processing are called raw materials, and those that are part of the dosage form in a slightly modified or unchanged form are called ingredients. The final product of the technological process - finished product, and having passed one or more stages of processing -

intermediate or semi-finished product. In the process of processing

source materials can form separate fractions that are not part of the finished product, which are called production waste. If they are of consumer value, i.e., they can be recycled in the future, then they are by-product. Production wastes that are not subject to further processing and do not represent consumer value are waste. They are currently reduced to a minimum through the development of rational technologies or by transferring them into a by-product. Valuable solvents used in the technological process are subjected to regeneration and returned to production again. Finished product of unsatisfactory quality, i.e. technological marriage, which may result from the use of defective source material and in violation of technology.

During the production process, there are always material loss, formed as a result of spraying, evaporation, material sticking to the walls of the equipment, etc.

3. Material balance

material balance- this is the ratio between the quantities of raw materials, the finished product obtained, production waste and material losses. It underlies

production regulations, makes it possible to assess the correctness of the organization of the technological process, compare the effectiveness of its implementation in different industries and can be expressed by an equation, diagram or in the form of a table.

The material balance equation has the following form:

G1 = G2 + G3 + G4 + G5 ,

where G1 is the mass of raw materials; G2 - finished product;

G3 - by-products; G4 - garbage;

G5 - material losses.

In the absence of production waste, the material balance equation will take a simpler form:

G1 = G2 + G3 .

The material balance can be drawn up both in relation to the entire technological process, and in relation to each individual stage or production operation. It can cover all materials (general, total balance) or each individual component.

For example, to prepare 100 kg of boric ointment, 5 kg of boric acid and 95 kg of petroleum jelly are taken. Received 96 kg of ointment containing 4.9% boric acid. The material balance equation will look like: 100 = 96 + 4.

The material balance can be presented in the following form.

The material balance for each component is made taking into account its percentage in the finished product. In this case, for boric acid G1 = 5 kg, the value of G2 should be calculated as follows:

4.9 96 \u003d 4.704 kg. Then G5 = 0.296 kg. 100

The material balance equation for boric acid will take the following form:

5 = 4,704 + 0,296.

For vaseline G1 = 95 kg, G2 = 91.296 kg, since the total loss is 4 kg, of which the loss of vaseline 4 is 0.296 = 3.704 kg.

The material balance equation for Vaseline would be:

95 = 91,296 + 3,704.

Thus, the material balance makes it possible to determine the absolute value of material losses (waste ∑). From the material balance equation, the technological output (η) and the consumption coefficient (Krax) are found.

Technological yield η is the ratio of the mass of the finished product (G2 ) to the mass of the raw materials taken (G1 ), expressed as a percentage:

G2 100%


		(G3
			G4)

Technological waste (∑) is the ratio of the mass of material losses (G5) to the mass of raw materials (G1), expressed as a percentage:

G5 100%,

or in the presence of production waste:


		(G3
			G4)

The lower the technological waste (∑), the more profitable the production.

The consumption coefficient (Krax) is the ratio of the mass of the taken raw materials to the mass of the finished product obtained. Krax is a dimensionless quantity.

					; or to			G 1 (G 3 G 4 )

The consumption coefficient is always greater than one, calculated with an accuracy of 0.001.

The smaller the Crash, the better the technological process is organized. By multiplying the figures of the recipe, compiled without taking into account material losses, by the consumption coefficient, working recipes are obtained. This is necessary to ensure the output of a given amount of the finished product.

4. Energy balance

In addition to the material balance of raw materials in production, an energy balance is also drawn up, representing the ratio of the amounts of energy introduced into the technological process and released at its completion. For example, the energy heat balance is represented by the following equation:

Q + Q1 . + Q2 = Q3 + Q4 ,

where Q is the heat introduced into the technological process with the initial substance, J;

Q1 - heat supplied from outside, J;

Q2 - thermal effect obtained due to exothermic or endothermic reactions. It may have a "+" sign or

Q3 - heat leaving with the finished product, J; Q4 - heat loss, J.

National standard of the Russian Federation Rules for the production and quality control of drugs

military means

GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP) GOST R 52249-2004

2004 N 160-st.

Introduction

In world practice, one of the most important documents that defines the requirements for the production and quality control of medicines for humans and animals is the "Rules for the production of medicines" - "Good Manufacturing Practice for Medicinal Products (GMP)", aimed at ensuring

maintaining a high level of quality and safety of medicinal products and ensuring that the medicinal product is manufactured in accordance with its formula (composition), does not contain foreign inclusions, is properly labeled, packaged and retains its properties throughout the entire shelf life.

Application area

This International Standard specifies requirements for the manufacture and quality control of medicinal products for human and animal use. The standard applies to all types of medicinal products and establishes general requirements for their production and quality control, as well as special requirements for the production of certain types of medicinal products (Appendices 1–18). The standard does not apply to ensuring industrial safety, fire safety, explosion safety, chemical safety and safety of other types in the production of medicines, the requirements for which are given in other regulatory documents.

Primary requirements

1. Quality management

Principles

1.1. The manufacturer of medicinal products must organize their production in such a way that the medicinal products are guaranteed to meet their intended use and requirements and do not pose a risk to consumers due to violations of safety, quality or efficacy. The responsibility for meeting these requirements lies with the managers and all employees of the manufacturer, as well as suppliers and distributors. To achieve this goal, on the basis of this standard (GMP Rules), a quality assurance system must be created at the enterprise, which includes a quality control organization.

The requirements for the quality assurance system should be fully documented and the effectiveness of its functioning should be monitored. All links of this system follow

should be staffed with qualified personnel, provided with the necessary premises, equipment, etc. Responsibility for the functioning of the system rests primarily with managers and authorized persons.

The basic principles of quality assurance, GMP Rules and quality control are interrelated and are of paramount importance in the organization of the production of medicines.

Quality assurance

1.2. Quality assurance is a complex task, the solution of which requires the implementation of all measures aimed at achieving the specified requirements for the quality of medicines. Quality assurance is based on the fulfillment of the requirements of this standard and other normative documents. The quality assurance system (quality system) in the manufacture of medicines must ensure the following.

I. Medicinal products are developed taking into account the requirements of this standard and the requirements for the work of laboratories.

II. For all production and control operations, documentation has been developed in accordance with this standard.

III. The responsibilities and duties of all employees are clearly defined.

IV. Measures are in place to ensure that source and packaging materials are produced, supplied and used in accordance with specified requirements.

V. Control of intermediate products and the technological process (in-house control), certification (validation) of processes and equipment are carried out to the extent necessary.

VI. Production and control of finished products comply with approved instructions (methods).

VII. The sale of medicinal products prior to the issuance of a release permit by an authorized person is excluded. An authorized person must confirm that each batch of products is manufactured and tested in accordance with the established requirements.

VIII. The existing system of measures ensures the level of quality of medicines during their storage, shipment and subsequent handling throughout the entire shelf life.

IX. The procedure for conducting self-inspection and/or quality audit allows you to regularly evaluate the effectiveness of the quality assurance system.

Requirements for the production and quality control of medicines

1.3. This standard is part of the quality system and is aimed at providing assurance that the production and quality control of products constantly meet the requirements established by

updated in documentation.

Primary requirements

I. All production processes should be clearly regulated and periodically reviewed in the light of experience gained. The stability of the production of drugs with a given quality in accordance with their specifications should be monitored.

II. Certification (validation) of critical stages of production processes should be carried out, including when significant changes are made to the technological process.

III. All necessary conditions should be provided to comply with the requirements of this standard, including including the presence of:

a) trained and certified personnel; b) necessary premises and areas;

c) appropriate equipment and service system; d) materials, means of packaging and labeling, satisfying

meeting the given requirements; e) approved instructions and methods;

f) required storage and transportation conditions.

IV. Instructions and procedures should be specific, set out clearly and unambiguously in writing.

V. Personnel must be trained to follow instructions correctly.

VI. During the production process, protocols should be drawn up (filled in handwritten form and / or using technical means) documenting the actual implementation of the technological stages provided for in the instructions and the receipt of products of the required quality in a quantity that meets established standards. All deviations must be investigated and recorded in full.

VII. Batch records, including product sales documentation, must enable traceability of the manufacture of each product batch and must be kept in full and in an accessible form.

VIII. The procedure for the sale (wholesale) of products should minimize any risk to its quality.

IX. A system should be in place to recall any batch of product from sale or supply.

Send your good work in the knowledge base is simple. Use the form below

Students, graduate students, young scientists who use the knowledge base in their studies and work will be very grateful to you.

Summary

MEDIA-ROST LLC (hereinafter referred to as the Enterprise) was established by Vladimir Alekseevich Glubokov and Eduard Konstantinovich Khristin (hereinafter referred to as the Project Initiators) in October 2001 to implement the idea of creating a pharmaceutical production in Volgograd. The initiators of the project have experience in creating and managing Russian and joint ventures and have been in business since 1987.

The idea of creating a pharmaceutical production in the Southern Federal District of the Russian Federation arose from the initiators of the project in 1998. There are practically no pharmaceutical production facilities on the territory of the Okrug, and medicines are mainly imported from abroad (64%) and from other regions of Russia.

Div class="contentByTheme__wrapper" style=" padding: 18px 18px 10px 18px;">

The Enterprise being created should ensure the uninterrupted production of a wide range of high-quality pharmaceutical products (finished medicines and substances) to meet the needs of all population groups in the region for medicines at affordable prices, reduce Russia's dependence on imports of medicines and raw materials for their production. In terms of its capacity, the Enterprise should become the largest in the Southern Federal District and enter the top five largest pharmaceutical enterprises in Russia.

The actual pre-project work was started by the project initiators in 1998. Since then, support has been received from the administration of the Volgograd Region and the Sovetsky District of Volgograd, and the issue of allocating a land plot for construction has been resolved. The initiators of the project received support from the Ministry of Health of the Russian Federation. The best specialists of the Volgograd branch of the International Academy of Investments and Economics of Construction, as well as specialists of the Pharmaceutical Faculty of the Volgograd State Medical Academy were involved to work out the issues of creating production. An in-depth marketing study of the pharmaceutical market in Russia and the Southern Federal District has been carried out, and our own plan for the production and sales of finished medicines and substances has been substantiated.

Investment costs for the project amount to 42 million US$. In order to receive half of the specified amount, MEDIA-ROST LLC intends to attract investors to equity participation in the project. The rest of the Company plans to receive as state support in the form of a credit line or guarantees.

The presented materials and calculations were performed by CJSC Investment Company "Contrast" on the basis of its own marketing research of the pharmaceutical market, the forecast for the development of the external economic environment for the duration of the project, the analysis of project risks, as well as taking into account the timing of the construction and commissioning of the pharmaceutical plant planned by the Company and the estimated sales volumes FPP and substances.

The calculations were performed in the environment of the licensed software product Project Expert 7.01 in accordance with the standards of the international economic organization UNIDO.

Integral indicators of investment attractiveness

The period for calculating integral indicators is 90 months.

Goals and objectives

Mission of the Enterprise, main goals and objectives of the project

The mission of the Enterprise is to ensure the uninterrupted production of a wide range of high-quality pharmaceutical products to meet the needs of all population groups in the region for medicines at affordable prices, to reduce Russia's dependence on imports of medicines and to unlock the entrepreneurial, creative and spiritual potential of the owners and employees of the Enterprise.

Project goals:

It is possible to quickly reach the planned capacities.
Use of advanced technologies and modern equipment.
Production of quality products and setting reasonable prices for it.
Conquering and retaining most of the regional consumer market.
Carrying out a well-thought-out production and marketing policy that meets other goals of the Enterprise.
Carrying out independent research work, timely renewal of capacities and range of manufactured products.
Launch of own developments, creation and maintenance of original brands.
Development and expansion of the Enterprise to an economically justified scale.
Access to foreign markets.
Providing its owners with income, creating conditions for the disclosure of the entrepreneurial, creative and spiritual potential of employees.

To achieve the strategic goals of the project, the Company needs to solve the following main tasks:

After determining the circle of project participants and investors:

Develop the architectural concept of the Enterprise.
Develop a complete set of construction documentation.
Ensure the construction of the Enterprise in the planned time frame.
Ensure the selection, ordering and payment of the main and auxiliary equipment.

After the start of production activities:

Update the product range.
Develop a marketing strategy for the Company's products.
Conduct independent research.
Lead the development and implementation of their own brands.
Carry out constant quality control of the manufactured drugs and substances for compliance with GMP requirements.

Successful solution of all the above tasks will help the Company cover up to 25% of the region's needs for FPP, take a leading position among Russian manufacturers of medicines and substances with the prospect of entering the international market.

Project initiators

To implement the project, a new legal entity LLC "MEDIA-ROST" was registered.

The initiators of the project - General Director of MEDIA-ROST LLC Glubokov Vladimir Alekseevich and Deputy General Director Khristin Eduard Konstantinovich are the owners of the Enterprise.

The initiators of the project have experience in creating and managing Russian and joint ventures (JVs). So, in 1987, on the initiative and with the direct participation of V.A. Glubokov. a private enterprise specializing in the construction of urban engineering networks and communications was established. As a result of the intensive development of the business, which was ensured by the energy of the director of the enterprise V.A. Glubokov, the annual volume of work increased from $20,000 in 1987 to $5 million in 1994. For the period from 1990 to 1996, on the initiative and with the direct participation of V.A. Glubokov. 2 joint ventures were created, one of which is still operating. It should be noted that Glubokov V.A. has a high level of theoretical and practical training in managing an enterprise in a crisis situation (certificate of an anti-crisis manager of the II category), which allows him to anticipate the growth of negative trends in a timely manner and plan adequate actions to overcome them. From the very beginning of work on the project, the initiators of the project began to form a management team.

In the future, the Project Initiators plan to hold senior positions at the Enterprise being created, which will most likely require new knowledge in the field of managing large industrial facilities. In order to comply with the positions held by the Project Initiators, it is planned to undergo additional training during the construction period under one of the training programs for top managers, which will allow systematizing the existing knowledge and experience of previous work, identifying and closing problem areas in advance, and establishing useful contacts.

To date, the Project Initiators have invested about $110,000 of their own funds in the project. Appendix No. 4 to the business plan shows that in the pre-investment period, due to the work performed by the Project Initiators, the total risk of the project decreased from 28.39% to 20.63%. Thus, from the point of view of risk mitigation, the cost of the work already performed by the Project Initiators is estimated at 3.259 million US dollars.

Entrepreneurial intent

The entrepreneurial idea of creating a pharmaceutical production on the territory of the Southern Federal District of the Russian Federation arose in 1998. The main initiator of the project and the author of the entrepreneurial idea is the head of LLC "MEDIA-ROST" Glubokov V.A.

The entrepreneurial idea of the project is to make a profit by creating a modern high-tech pharmaceutical production in the Southern Federal District of the Russian Federation, which fully meets the long-term needs of the state and the region.

The main features of the entrepreneurial idea of the project include:

orientation to the general population, which is achieved by the Company's attractive pricing policy and a wide range of manufactured pharmaceutical products;
focus on the production of import-substituting drugs, as a result of which Russia's security is increased and dependence on imported drugs is reduced;
the desire of the Project Initiators not only to produce finished dosage forms from purchased raw materials, but also to produce the active substance (substances) for the domestic market;
the use of flexible technological schemes of production, allowing you to quickly change the range of products in accordance with the emerging market conditions;
Compliance of the quality of manufactured FPP and substances with GMP and ISO 9001 standards.

Pre-investment study of the project

For the period since 1998 by the Enterprise:

Received support from the administration of the Volgograd region and the Soviet district of the city of Volgograd, at the federal level - support from the Committee of the State Duma of the Russian Federation on credit organizations and financial markets, as well as the head of the Ministry of Health of the Russian Federation.
A decision was received from the municipal authorities to provide a plot of 10 hectares for the location of pharmaceutical production in the city of Volgograd.
An in-depth marketing research of the pharmaceutical market of the Russian Federation and the Southern Federal District was carried out.
Preliminary work has been carried out to obtain a state order for the products of the Enterprise from the Ministry of Health, the Ministry of Defense and the Ministry of Emergency Situations of the Russian Federation.
Specialists of the International Academy of Investments and Economics of Construction, including those working in the Volgograd branch, were involved to work out the issues of creating production.
An analysis was made of companies with experience in building similar plants in Russia. A dialogue was established and negotiations were held with the Yugoslav company Hemofarm, which confirmed in writing its readiness to carry out design, construction, installation and commissioning work related to the creation of pharmaceutical production in the Southern Federal District of the Russian Federation.

Significance of the Enterprise for the state and the region

The state needs to develop domestic production of medicines to provide the country's population with high-quality and affordable pharmaceutical products in sufficient volume and assortment and to reduce dependence on imports. The scale of the planned establishment of the Enterprise goes beyond the regional, and will have a serious impact on the development of the entire pharmaceutical industry in Russia.

For the economy of the Southern Federal District, the creation of such an enterprise will be very significant. The initiators of the project are considering the issue of including the Enterprise in the development program of the Volgograd region. Let us indicate the main positive aspects of the creation of modern pharmaceutical production in the region:

Large tax deductions to the regional budget. A significant reduction in the share of expenditures of the population of the region on medicines due to the production of high-quality pharmaceutical products and lower prices for it, and, as a result, the expansion of the possibility for citizens to use the released funds to meet other needs (balanced nutrition, education, sports, etc.).
Providing medical institutions in the region with cheaper and better medicines.
Creation of new jobs.
Strengthening scientific potential (development and implementation of the latest pharmaceutical technologies).

Marketing Analysis

The full results of the marketing research of the pharmaceutical market in Russia and the region under consideration are given in Appendixes No. 1 and No. 2 to the business plan.

State of the domestic pharmaceutical market

The Russian pharmaceutical market is showing high growth rates. In terms of volume, it is in second place after the food market, and according to the estimates of leading Russian experts, at the beginning of 2002, the capacity of the Russian pharmaceutical market amounted to 3.5 billion US dollars.

In Russia, medicines are produced at 117 enterprises, with 16 largest enterprises accounting for 70% of production. 84% of domestic pharmaceutical industry enterprises have a non-state form of ownership, which cannot be found in any country in the world.

According to official statistics, there are currently about 7 thousand wholesalers in Russia (according to Rospharm, about 3 thousand), although, according to experts, 250-300 large wholesale companies are enough to meet the needs of the domestic market.

Russian medicines

Prior to the 1998 crisis, imported products practically did not meet with serious competition from Russian manufacturers, filling in the gaps in their assortment. However, after the crisis, many domestic pharmaceutical plants relied on the production of import-substituting drugs.

The range of import-substituting products is now approaching two hundred items, and in many respects, domestic production can satisfy all the needs of the Russian market. However, this does not yet have a significant impact on the ratio of imported and domestic drugs. The fact is that most foreign manufacturers are oriented towards consumers with incomes above the average level, who can afford expensive medicines. In addition, the assortment of Russian manufacturers is still limited, and for entire therapeutic groups there is no competition with imports at all.

The diagram below shows the data of the State Statistics Committee of the Russian Federation and the Ministry of Industry and Science of the Russian Federation on the volume of production of medicines by Russian manufacturers in the period 1996-2002. (for 2002 forecast data are given):

According to experts, in the next 5 years (2002-2007), the production of anti-asthma, antihistamine, anti-tuberculosis drugs, plasma-substituting drugs, as well as drugs for the treatment of cardiovascular, eye, neuropsychiatric diseases, diseases of the endocrine system, digestive organs, and dysbacteriosis will increase. . In the production of these drugs, domestic enterprises have so far lagged behind foreign companies due to the lack of modern equipment for the production of pharmaceutical substances.

In 2002, the leading Russian companies (Polipharm, Akrikhin, Kraspharma, Organika, Biosintez, Sintez, etc.) are planning to modernize their production facilities, allocating about 125 million US dollars for this, which will allow to reduce the technological gap from foreign competitors and occupy a niche in the changed market.

Production of substances

The production of drug substances in Russia before the collapse of the USSR was the basic sub-sector of the medical industry: until 1992, domestic substances were the main export products of the industry to the former Soviet republics. With the transition to market relations, due to the high material consumption and energy intensity of the production of substances, their production has become unprofitable. In 1998, the range of produced substances narrowed by 2.7 times compared to 1992 (to 100 items), the production volume decreased by 5 times and amounted to 3.5 thousand tons (19.8% of the 1992 level) , and in 1999 it decreased to 3 thousand tons and amounted to only 17.2% of the base year level. The output of antibiotic and vitamin substances is constantly decreasing (with the exception of a slight increase in their output in 1995 and 1997).

As a result of the constant rise in prices for raw materials and energy resources from 1992 to 2001, medical industry enterprises were forced to significantly reduce the production capacity for the production of substances. Thus, about 40% of the capacities were withdrawn from production. In 2000, the industry's average level of capacity utilization for the production of substances was 18.5%, including 14.7% for synthetic drug substances, 24.3% for antibiotics, and 34% for vitamins.

The rise in prices for material resources led to a significant increase in the cost of substances, as a result of which prices for this type of product became higher than world prices. Therefore, domestic manufacturers of finished dosage forms began to purchase imported substances as raw materials, significantly narrowing the sales market for Russian products. To bring prices for pharmaceutical substances to the world level, domestic enterprises need to reduce their production costs by at least 2 times, which is possible only with the use of new resource-saving and less energy-intensive technologies. However, given the current financial situation of enterprises in the industry, it is extremely difficult to modernize production.

And yet, despite the existing difficulties, in 2001, the production of high-tech medicinal substances was launched on the Russian pharmaceutical market for the first time. The Farmavit group launched the Pharmsintez plant in the village of Kuzmolovo (Leningrad region) for the production of high-tech medicinal substances. This is the first enterprise of its kind in Russia. Domestic pharmaceutical enterprises, as a rule, produce inexpensive substances and prefer to reduce their share in production, since they are far from being as profitable as finished drugs.

The holding "Farmavit" includes JSC "Farmavit", "ASGL - Research Laboratories", "National Biotechnologies", research and production company "Farmsintez". The holding is a shareholder of several pharmaceutical plants - Biokhimik (Saransk), Biosintez (Penza), AKO Sintez (Kurgan). According to Pharmexpert data, these plants account for about 20% of the Russian production of finished medicines.

The plant was designed with the participation of leading foreign and Russian companies. Currently, the installation of unique technological equipment is being completed. The design capacity of the plant is up to 20 tons of substances per year. The area of the occupied territory is 5 hectares.

At the first stage, it is planned to produce 10 types of chemical substances. In the future, it is planned to master the production of up to 50 types of substances.

The enterprise was supposed to start work at the end of December 1999, but the deadlines were postponed several times. JSC "Farmavit" and CJSC "Gazenergofinance" acted as investors of the project. The cost of the project is $15 million. A third of the products will consist of original drugs developed by the Farmavit holding, the rest will be generics.

Pharmsintez will occupy a new niche for Russian companies. Part of the produced substances will be supplied to the countries of Southeast Asia and North Africa. The products of this enterprise will be 30% cheaper than imported analogues. The strategic partner in this project is the Hong Kong company Cathey World Investments, which provided Farmavit with an investment loan in the amount of $2.5 million. According to pharmaceutical market experts, not a single Russian enterprise produces high-tech substances yet. According to Pharmmedsbyt experts, the cost of high-tech substances can be up to $5,000 per 1 kg. At the same time, substances produced by Russian enterprises usually cost from $2 to $10 per 1 kg. The only exception is the dikain substance, which is produced by the Novokuznetsk plant "Organika" - it costs $1000 per 1 kg. If the substances produced by Pharmsynthez really are one-third cheaper than imported analogues, this may be of interest to drug manufacturers and affect the price of the final product.

Imported medicines

Despite the fact that the increase in the share of Russian pharmaceuticals in the domestic market has become one of the most important trends in 2000-2001, imported finished medicinal products (FPP) continue to occupy an unreasonably large place on it.

The diagram below shows the structure of the Russian drug market at the beginning of 2002 by manufacturers. The main competitors for domestic pharmaceutical companies are enterprises from the CIS countries, the Baltic states, Eastern Europe, as well as India and Turkey. Among the competitors are such traditional Russian suppliers as Chinoin and Gedeon Richter (Hungary), KRKA (Slovenia), Zork, Zdravle (Yugoslavia), Ranbaxy Laboratories, Dr. Redd's Laboratories, Torrent (India). Together they fill about 70% of the Russian pharmaceutical market.

Since the beginning of the 90s, the main specialization of pharmaceutical factories of competitors has been the production of generics, i.e. original developments of leading Western firms, the term of the exclusive patent for which has expired. Prices for such drugs are lower than for original drugs. Another group of suppliers are pharmaceutical companies from developed countries: Astra, Bayer, Bristol-Myers Squibb (BMS), Ebewe, Hoechst, Pfizer, Glaxo Welcom, etc. There are about 40 such companies, they mainly export drugs that have no analogues and monopoly high prices.

The Russian pharmaceutical market is unbalanced - generics occupy an unreasonably large place on it. The cheapness of generics is, in fact, the main reason for their popularity. This trend will continue over the next decade. According to experts, the production of generics is the most important and leading strategic direction in the development of the Russian pharmaceutical industry.

On the Russian pharmaceutical market, the FPPs of the following pharmaco-therapeutic groups are in the greatest demand:

cardiovascular agents;
antibiotics;
antipyretic and anti-inflammatory;
antihypertensive (hypertensive) drugs.

Description of the geographic segment

The projected enterprise will be located on the territory of the Volgograd region. In its activities, it should focus primarily on the domestic market. Up to 80% of manufactured products are planned to be sold in the Southern Federal District. The rest of the products will be sold in the Volga Federal District, Voronezh, Sverdlovsk and Chelyabinsk Regions of the Central and Ural Federal Districts.

The total area of the region under consideration is 1914.29 thousand square meters. km. The population is 62.753 million people. The Southern Federal District contains 13, and the Volga District - 14 republics, territories and regions.

In total, there are 13 operating pharmaceutical enterprises of Russian and regional significance in the region.

Pharmaceutical production in the region under consideration

Region	Business name	Manufactured products
Volga Federal District
Mari El Republic	JSC "ICN-Marbiopharm", Yoshkar-Ola	Medicines, vitamin preparations
The Republic of Mordovia	OJSC "Biochemist", Saransk	Antibiotics, blood substitutes, diuretics, local anesthetics, tablets, ointments
Kirov region	JSC "Vostok" Kirov region, Omutninsky district, Vostochny settlement	Medicines, injection solutions, disposable syringes
Nizhny Novgorod Region	AOOT "Nizhpharmzavod", Nizhny Novgorod	Medicines, more than 90 items
Penza region	OJSC "Biosintez", Penza	Medicines, antibiotics
Republic of Tatarstan	"Kazan Pharmaceutical Factory" "Tathhimpharmaceuticals"	The youngest farm. Russian factory established in 1997 (GMP) One of the largest pharmaceutical companies in Russia, the only manufacturer of suture surgical materials (GMP) in Russia
Republic Bashkortostan	OAO "Ufa Vitamin Plant" Ufa SUE "Imunopreparat", Ufa	Finished medicinal products of various pharmacotherapeutic groups, substances, dietary supplements Immunobiological and medicinal products. Preparations of more than 80 items
Southern Federal District
Volgograd region	Volgograd Pharmaceutical Factory	Camphor alcohol, formic alcohol, pertussin, licorice root syrup
Rostov region	"Novocherkassk Plant of Synthetic Products", Novocherkassk	methanol, drugs
Ural federal district
Sverdlovsk region	OJSC "Irbit Chemical and Pharmaceutical Plant Plant", Irbit	Painkillers, antipyretics, vitamin and cardiovascular drugs
Chelyabinsk region	AOOT "Polypharm", Chelyabinsk	Medicines for internal and external use

The nearest pharmaceutical plants of Russian importance to the place of creation of production - OJSC "Biosintez" (Penza), "Nizhpharmzavod" (Nizhny Novgorod), "Kazan Pharmaceutical Factory", "Tatkhimfarmpreparaty" (Kazan) are located in the Volga Federal District. At the same time, in the Southern Federal District (SFD) there are only two enterprises for the production of medicines, which are focused exclusively on local markets and do not have the capacity to produce modern medicines in an assortment and quantity sufficient for the selected geographical segment.

Peculiarities of FPP consumption in the region

The structure of the incidence of the region's population is in many respects similar to the structure of the incidence in industrialized countries - an aging population, diseases of a developed society (cardiovascular, oncology, diseases of the digestive system).

Thus, the needs of the region for certain drugs mainly depend on the structure of the incidence of its population.

The diagram below shows the structure of the incidence of the population of the region under consideration, made according to the data of the Ministry of Health of the Russian Federation.

The import of medicines to the regions of Russia is quite large. The Southern Federal District almost completely depends on imports (there are no significant pharmaceutical productions on its territory), and the Volga Federal District is also heavily dependent on imports, despite the fact that such large pharmaceutical productions as OAO "Biosintez", OJSC "ICN-Marbiopharm", "Nizhpharmzavod" and a number of other fairly large ones.

Interest in the pharmaceutical market of the study region is actively shown by foreign manufacturers, including Gedeon Richter (Hungary), Hoechst Marion Roussel Ltd, Berlin-Chemie AG/Menarini Group, KRKA D.D., Hinoin, etc.

According to the Department of Pharmacy under the Ministry of Health of the Russian Federation, the share of imported medicines in the total volume of medicinal products in the region's market is 64%. At the same time, according to experts, the ratio of domestic and imported drugs is considered to be optimal as 70% to 30%. Thus, we can conclude that there is a significant shortage of cheap domestic drugs in the pharmaceutical market of the region.

Analysis of the pharmaceutical market in the region under consideration

Formation of a strategy for the behavior of an enterprise in the market is impossible without market analysis, competitive and situational analyses.

A complete analysis of the pharmaceutical market in the study region is set out in Appendix No. 2 to the business plan. Below are the main results of the analysis.

Market segmentation

Segmentation by type of business

The pharmaceutical market of the region can be divided into the following main segments:

production of substances;
production of finished medicinal products (FPP).

The subjects of the market are large and medium-sized pharmaceutical enterprises in the region.

Production of substances by pharmaceutical enterprises of the region.

Groups of manufactured substances

Name of groups of produced substances:

Natural antibiotics (substances obtained by microbiological method)
Semi-synthetic and synthetic antibiotics
Cardiovascular agents
Anti-inflammatory and analgesic substances
Other types of substances
Insulin production
Production of vitamin preparations, including cyanocobalamin (vitamin B12)

Production of FPP by pharmaceutical enterprises in the region.

(*) In the table, the following designations of the groups of produced FPPs are accepted:

1 - Sterile powders of antibiotics packed.

2 - Tablet preparations.

3 - Sterile and non-sterile solutions.

4 - Ampoule forms.

5 - Ointments, suspensions, powders, capsules.

6 - Endocrine drugs (insulin)

7 - Vitamins (solid forms, injectable forms).

Pharmaceutical companies in Russia are updating their range of OTC drugs mainly with generic drugs made from imported substances. This is due to the lack of Russian substances in the pharmaceutical market.

Segmentation by product type

Segmentation by types of products, taking into account the existing structure of demand in the selected geographical segment, as well as studies of regional pharmaceutical markets conducted by leading experts, made it possible to determine that the greatest consumer preference among FPPs is given to tablet medicines.

Analysis of market segments by types of business

Production of substances

The lack of available reliable statistical information on the volumes of production by Russian pharmaceutical companies of the main types of substances, as well as data on their import, makes it difficult to conduct a quantitative analysis of this market segment.

The current situation with the production of substances in the regional pharmaceutical market can be assessed by analyzing the distribution of production of various groups of substances in the pharmaceutical enterprises of the region.

The results of the analysis of the production of various groups of substances at the pharmaceutical enterprises of the region are shown in the diagrams.

The first diagram shows data on the number of groups of substances produced at the main regional pharmaceutical enterprises.

The second diagram shows the distribution of the main regional producers by the presence of production of certain groups of substances.

In the table below, groups of substances are arranged and ranked in ascending order by the number of regional manufacturers producing them. A lower value of the attractiveness rank of a group of substances corresponds to a greater attractiveness for locating the production of this group at the Enterprise being created.

Group of manufactured substances	Number of manufacturers	Rank of attractiveness of a group of substances
Insulin	2	1
Natural antibiotics (substances obtained by microbiological method)	6	2
Semi-synthetic and synthetic antibiotics	6	2
Cardiovascular agents	6	2
Vitamin preparations, including cyanocobalamin (vitamin B12)	7	3
Anti-inflammatory and analgesic substances	8	4
Other types of substances	10	-

The number of different groups of substances produced at one regional pharmaceutical enterprise ranges from one to six (“Tatkhimfarmpreparaty”), and on average four different types of substances are produced at one enterprise.

The least represented on the regional pharmaceutical market is the production of the following groups of substances:

insulin
Natural antibiotics (substances obtained by microbiological method).
Semi-synthetic and synthetic antibiotics.
Cardiovascular funds.

Vitamin preparations, including cyanocobalamin (vitamin B12).
Anti-inflammatory and analgesic substances.

Manufacture of finished medicinal products (FPP)

Consider the features of the regional market for the production of drugs.

The situation with the production of OTC drugs in the regional pharmaceutical market can be assessed by analyzing the distribution of production of various groups of OTC drugs in the region's pharmaceutical enterprises.

The results of the analysis of the production of various groups of FPPs at the main pharmaceutical enterprises in the region are shown in the diagrams.

The first diagram shows data on the number of different groups of FPPs produced at the main pharmaceutical enterprises in the region.

The second diagram shows the distribution of the main producers in the region by the presence of production of certain groups of drugs.

The same diagrams show the average values of the analyzed parameters (blue color).

In the table below, the FPP groups are located and ranked in ascending order by the number of regional manufacturers producing them. The lower value of the attractiveness rank of the FPP group corresponds to the greater attractiveness of this group for production at the projected Enterprise.

The number of different types of OTC drugs produced at one regional pharmaceutical enterprise varies from one (Kazan Pharmaceutical Factory) to seven (AKO Sintez), and on average, one enterprise produces four different types of OTC drugs.

The production of the following groups of FPPs is least represented on the regional pharmaceutical market:

Endocrine drugs (insulin).
Sterile powders of antibiotics packed up.
ampoule forms.
Ointments, suspensions, powders, capsules.

The production is represented to a greater extent:

Vitamin preparations (solid forms and injection forms).
Tableted drugs.
Sterile and non-sterile solutions.

Analysis of market segments by product types

Analysis of the regional market by pharmaco-therapeutic groups of drugs

The table shows the results of ranking the segments of the regional pharmaceutical market according to FTG drugs, obtained by analyzing the predicted volumes of these segments. The lowest value of the rank corresponds to the largest predicted volume of the regional market segment.

Analysis of the regional market by type of FPP

The diagram shows the predicted values of the capacity of the segments of the regional pharmaceutical market by type of FPP.

Analysis of the regional market by groups of solid drugs

The diagram shows the results of predicted values of the capacity of the regional pharmaceutical market segments by groups of solid drugs.

Share of products in the total market volume

The sales market for the Company's products has sufficient potential to ensure solvent demand for its products. The potential volume of the share of the regional pharmaceutical market that the Company can take is about 150 million US$/year, which is 25% of the total volume of the region's market.

The output volumes of the Enterprise, firstly, must be substantiated by the analysis of the current and forecast of the future potential capacity of the regional pharmaceutical market, and, secondly, correspond to the typical values of large Russian pharmaceutical enterprises. In this case, the Company's actions, most likely, will not provoke aggressive actions on the part of major world manufacturers to prevent a competitor from entering the market they have already mastered, and the Company's products will be able to gradually replace imported imported drugs without intense competition.

The diagrams below give an assessment of the minimum and maximum values of the potential share of the projected Enterprise in the regional pharmaceutical market for various pharmaco-therapeutic groups of drugs.

Competitive Analysis

Competing enterprises

The competitive analysis given in Annexes No. 1 and No. 2 made it possible to identify the following main competitors of the Company:

Large and medium-sized pharmaceutical enterprises in the region that produce similar products.
Dealer firms supplying small wholesale firms with FPP directly from manufacturers (Russian and foreign) to the region.

Currently, there are 5 large and medium-sized pharmaceutical enterprises of Russian importance in the region under consideration.

Company "Nizhpharm" (Nizhny Novgorod)

The main performance indicators of the company "Nizhpharm" in 2001:

Sales volume - 75547 thousand packs (753.744 million rubles, in foreign currency 25792 thousand dollars).
The share of Nizhpharm in the Russian pharmaceutical market is 0.86%.
Assortment - more than 90 items (share of brands - 38.9%).
Brands - sales leaders: Betanikomilon, Vitaprost, Levomekol, Osarbon, Chondroxide, Cefekon, Essliver Forte, Espol, Efkamon.

Pharmaceutical company Nizhpharm is one of the ten largest pharmaceutical companies in Russia. Currently, the company is equipped with modern highly efficient domestic and imported equipment. Production capacities allow to produce up to 150 million packages of finished medicines annually. The company is traditionally a leader in the production and sales of ointments and other soft dosage forms.

In 1998, the production of solid form medicines - tablets was mastered according to international GMP rules. Currently, the reconstruction of production is being completed at the enterprise.

At the end of December 2000 the production of tablets was recognized as complying with the requirements of international GMP rules and the Industry Standard OST 42-510-98 "Rules for the organization of production and quality control of medicines (GMP)". April 2001 Nizhpharm received certificates of conformity of the quality system to international standards ISO 9001:1994 and GOST R ISO 9001:1996. Nizhpharm's development strategy provides for a complete modernization of the enterprise in accordance with international GMP rules, which will make it possible to achieve excellent quality of manufactured drugs, as well as successfully compete with global pharmaceutical manufacturers. Nizhpharm manufactures more than 90 finished drugs in 32 pharmacotherapeutic groups.

Since 1995, the company has launched more than 40 new drugs on the market.

JSC "Biosintez"

Geographically, the closest to the site of the proposed construction is JSC "Biosintez" (Penza). According to the results of 2001, this enterprise was among the five largest manufacturers of pharmaceutical products in Russia.

Production activity at the enterprise began more than 40 years ago, in 1959. At that time, the main products of the enterprise were substances obtained by the microbiological method - the antibiotic biomycin and vitamin B12. Subsequently, the list of manufactured products was replenished with the antibiotic substances of oleandomycin, tetracycline, nystatin, heliomycin, fusidine, levorin, as well as other drugs.

Subsequently, the plant began the production of finished medicines: in 1961, the production of tablets was mastered, in 1971 - infusion solutions and packaged injection powders. In 1986, the production of insulin began, in 1989 - heparin.

At present, the enterprise produces FPP and substances. The range of manufactured products is more than 120 names of medicines of nine pharmacotherapeutic groups. 30% of medicines are included in the list of vital medicines. The volume of marketable output for the first half of 2001 amounted to 377 million rubles, sales proceeds - 350 million rubles, and profit from sales - 66 million rubles. The company employs more than four thousand people.

The company's equipment includes tablet presses "Kilian" and "Fette", installations for coating tablets with a film of aqueous solutions and organic solvents. Packing, packaging and stacking of tablets is carried out by the automatic line "Zanazi". The total capacity of the tablet production shop is more than 100 million packs No. 15 per year.

In addition to preparations in the form of tablets, JSC "Biosintez" produces injectable preparations in the form of powders and solutions. The complex for the production of powders includes equipment from the firms "Zanazi", "Huber" and others. Capacities for the production of infusion solutions include all types of equipment for the preparation of solutions, washing, sterilization, bottling and packaging of bottles in compliance with sterile production conditions, which makes it possible to produce about 18 million bottles of blood substitutes, blood preservatives, saline and detox solutions per year. In 1999, the production of ampoules was mastered. Three lines of syringe filling of ampoules allow the production of about 100 million ampoules with a capacity of 2 ml, 5 ml and 10 ml annually. The production of soft dosage forms includes areas for the production of ointments and suppositories.

Production capacities allow to produce about 700 conditional tons of substances by microbiological synthesis. In the first half of 2001, the output of antibiotic substances amounted to 100 conditional tons, i.e. capacities are loaded by approximately 28%, which is a fairly high figure for Russian producers of substances.

Currently, the main substance is benzylpenicillin sodium salt. JSC "Biosintez" is the only Russian manufacturer of antifungal antibiotic substances nystatin, levorin, griseovulifin. In addition to antibiotics, the range of substances includes the cardiovascular drug riboxin. The enterprise also has a complex for the production of endocrine preparations, which produces various enzymes for medical purposes: insulin, heparin, pancreatin, lidase, thyreodin, as well as the immunomodulating agent sodium nucleinate.

Further development of the enterprise is associated with technical re-equipment and increasing the efficiency of existing production. A major role in this is given to the scientific center of JSC "Biosintez". It includes the microbiological, chemical, chemical engineering and analytical sectors, as well as the finished dosage forms sector.

Currently JSC "Biosintez" sets itself the task of development and production of affordable import-substituting drugs, as well as the creation of its own original medicines. To this end, the enterprise is actively developing cooperation with the leading scientific centers of the country - the State Scientific Center of the Russian Academy of Medical Sciences, the All-Russian Scientific Center of BAV, the Hematological Center of the Russian Academy of Medical Sciences.

OAO "Officina"

Open Joint Stock Company "Officina" is located in Millerovo, Rostov Region. The company is the largest distributor of medicines in the South of Russia and specializes in providing a wide range of service and information services in the field of distribution of pharmaceutical products to pharmacies and medical institutions. The company has been operating in the Russian pharmaceutical market since 1989.

The structure of JSC "Officina" includes a central wholesale pharmaceutical warehouse, a customs warehouse, branches and representative offices in other cities and regions (Rostov-on-Don, Krasnodar, Pyatigorsk, Volgograd), nine pharmacies, in which five pharmacy points and two pharmacy kiosks are open , an optics store, as well as a repair and construction site, a gas station, an association of food and industrial stores.

The wholesale trade in medicines and medical products accounts for 85% of the company's turnover. The price list of the company contains more than 2000 names of medicines of almost all pharmacological groups. The range offered is constantly expanding and updating.

For many years JSC "Officina" has been cooperating directly with more than one hundred leading domestic and 60 foreign manufacturers of medicines and medical products. We have established strong relationships with all suppliers. Large volumes of purchases contribute to obtaining significant discounts, which in turn allows the company to set low prices and apply minimum trade margins to the products offered. For the clients of OAO "Officina" this makes it possible to have competitive prices for purchased goods.

The organization of sales in OAO "Officina" is based on the regional principle, i.е. all existing and potential clients of the company - pharmacies - are divided into geographical regions, each of which is handled by specific managers of the sales department or branch.

Informational interaction with its customers, as well as their direct service for the implementation of orders, OJSC "Officina" carries out both from the central office in Millerovo, and through branches and representative offices of the company. The presence of our own car park, which is constantly updated and expanded, allows customers who place an order with JSC "Officina" to have free delivery of goods exactly at the agreed time. Regular schedules for the delivery of goods to various regions have been worked out.

Specialists of JSC "Officina" regularly monitor the needs of customers. Thus, the company's management clearly understands the expectations of customers. In order to fully meet the needs of customers, JSC "Officina" purchases goods directly from manufacturers and, in general, on a full prepayment basis in order to ensure lower prices.

The main strategic task of OAO "Officina" remains the fullest possible satisfaction of demand in the market of pharmaceutical goods and services in the South of Russia.

Analysis of competitive forces

Competitive forces analysis is carried out in order to determine the opportunities and dangers that the Enterprise may face in the industry.

The table shows the generalized results of the competitive analysis according to M. Porter (model of the impact of five forces that affect the possibility of increasing prices and profits):

1. Risk of entry of potential competitors	While moderate, will increase over time. Barriers to entry: absolute cost advantage (lower production costs provide modern GMP-compliant facilities with significant benefits that are difficult for older facilities to achieve);
2. Rivalry among competing firms (pharmaceutical manufacturers and suppliers of imported drugs)	While weak. Russian companies are investing heavily in the re-equipment of enterprises. With the transition of industry enterprises to the GMP standard (by 2005) it will increase. The influence of domestic drug manufacturers will increase, the share of imports will gradually decrease.
3. The ability to "bargain" buyers.	Weak. The supply industry consists mainly of large and medium-sized enterprises. There are many buyers of FPPs, and there is a shortage of domestic pharmaceutical products.
4. The ability to "bargain" suppliers.	Weak. There are quite a lot of companies on the pharmaceutical market that supply substances for the production of OTC drugs. Before the Enterprise there is always a choice of the supplier.
5. Competition of substitute products.	While moderate. It will increase over time. Since the range of import-substituting drugs produced by domestic enterprises is constantly increasing.

SWOT analysis

SWOT - analysis is the most important part of the situational analysis, and should answer the following questions:

What are the strengths, weaknesses, opportunities and threats for the Company;

How strong are the competitive positions of the Enterprise.

Qualitatively, on the basis of expert assessments, we determine the list of strengths and weaknesses of the Enterprise, their relationship with opportunities and threats, and draw up a SWOT-analysis matrix.

Key Success Factors

The results of calculating the weighted assessment of the strategic strength of the Enterprise relative to competitors are shown in the table.

KFU	KFU weight	P	1	2
Use of flexible technological schemes of production	0,135	9(1,215)	7(0,945)	0
Creation of medium-tonnage production of new types of highly effective substances in accordance with GMP requirements	0,114	9(1,026)	8(0,912)	0
Compliance of the quality of produced FPP and substances with GMP and ISO 9000 standards	0,12	9(1,08)	7(0,84)	9(1,08)
Use of the latest technological equipment	0,098	8(0,784)	5(0,49)	0
Introduction of new technologies, own developments	0,095	8(0,76)	9,5(0,903)	1(0,095)
Ability to quickly respond to changing market conditions	0,105	7(0,735)	7,5(0,788)	9(0,945)
Attractive pricing policy	0,1	9(0,9)	9(0,9)	7(0,7)
Experience, qualifications of managers and staff	0,068	8(0,544)	9(0,612)	10(0,68)
Accurate customer satisfaction	0,052	8(0,416)	7(0,364)	10(0,52)
Convenient location	0,067	7(0,469)	8(0,536)	9(0,603)
Access to financial capital	0,046	5(0,23)	7(0,322)	9(0,414)
Weighted Strength Rating	1,00	8,159	7,612	5,037

Accepted designations: P - Enterprise; 1 - JSC "Biosintez"; 2 - OAO "Officina".

The diagram below shows the selected key success factors of the Enterprise (KSF) and the estimates of the weights of each KSF obtained by an expert.

conclusions

1. The large capacity of the pharmaceutical market makes business in this sector of the economy attractive and stable.

2. The plans of the state and some companies to expand the production of medicines leave from 3 to 5 years for a relatively easy entry into the market.

3. In the selected geographical segment, there is an acute shortage of inexpensive and high-quality domestic FPPs. The main needs for FPP are met through imports, which creates favorable conditions for import substitution.

4. The sales market for the Company's products has sufficient potential to ensure effective demand for its products. The potential volume of the share of the regional pharmaceutical market that the Company can take is 150 million US$/year.

5. The analysis of the regional pharmaceutical market allows us to identify the following range of products, the production of which is advisable to organize at the established Enterprise:

Substances:

insulin;
natural antibiotics;
semi-synthetic and synthetic antibiotics;
cardiovascular agents; funds acting on the central nervous system;

Medicinal preparations by pharmaco-therapeutic groups:

means for the treatment of diseases of the digestive tract;
analgesic, antipyretic, antirheumatic drugs;
antibiotics;
agents for the treatment of cardiovascular diseases;

Including for certain types of FPP:

tablet preparations (uncoated, coated, capsules);
ampoule forms;
ointments, suspensions, powders;
sterile powders of antibiotics packaged;
endocrine drugs (insulin).

6. Based on the above data and calculations made in Appendix No. 2, it can be concluded that the Enterprise potentially has greater competitive power compared to its closest competitors. The competitive advantage of the Company is achieved through the following key factors:

use of flexible technological schemes of production;
compliance of the quality of the produced FPP and substances with GMP and ISO 9000 standards;
creation of medium-tonnage production of new types of highly effective substances in accordance with GMP requirements;
the ability to respond quickly to changing market conditions;
attractive pricing policy;
use of the latest technological equipment;
introduction of new technologies, own developments.

Company Description

Corporate requirements for the organization of pharmaceutical production

Currently, for all pharmaceutical companies in Russia, the main document regulating the production of medicines is the GMP rules ("Good manufacturing practice" - "Rules for the correct production"). So far, not all enterprises in the country meet the requirements of these rules, but even now most pharmaceutical enterprises are directing significant funds for reconstruction and technical re-equipment.

Land plot

The initiators of the project reached an agreement with the administration of the city of Volgograd and the Volgograd region on the provision of a land plot of 10 hectares for the construction of a pharmaceutical plant. The site is located north of the village. MR-1 in the village of Gorky, Volgograd Region. The distance from the construction site to residential development is more than 2 km, which will allow, in accordance with the norms of SNiP, to place the most toxic and dangerous industries on the allocated territory. The size of the allocated area allows to expand production in the future.

The main parameters of the land plot

Name	Parameter description
Land area	The site has an area of 100 thousand square meters. m (10 ha) It is possible to transfer the land to the ownership of the Enterprise. The main condition for obtaining ownership of a land plot is the availability of investment resources in an amount sufficient to implement the project.
Electricity	The use of local networks capable of providing the production of electrical energy in the amount of 1000 kW/h.
Water	Water supply is provided by three collectors with a diameter of more than 300 mm, located at a distance of no more than 1 km from the site.
Gas supply	It is carried out by a medium pressure gas pipeline located at a distance of no more than 500 m from the site
Heat supply	In the future, it is planned to build its own gas-fired boiler house.
Domestic drains	Discharged to the city sewer.
Industrial waste	They are dumped into storage tanks located on the territory of the Enterprise, with subsequent removal by road to ponds - settling tanks of chemical enterprises in the city of Volgograd at a distance of no more than 100 km.

The main characteristics of the created production

The projected Enterprise is intended both for the production of FPP from purchased raw materials, and for the production of substances in accordance with ISO9001 international standards and GMP requirements, as well as for the introduction and implementation of new technologies and the development of new brands.

The total building area is more than 50 thousand square meters. m., including: 25% - production area, 60% - technical area and warehouses and 15% - non-production area.

Basic (sterile) production

Auxiliary production

Object name	Design (excluding VAT), thousand US$	Construction cost (without VAT), thousand US$
Room for plant for the production of water for ampoules	45	120
Premises for installation of a complex for water treatment for industrial needs	45	120
Room for the installation of technological equipment for the production of glass ampoules	150	300
Polyethylene bubble production workshop	20	120
	60	200
Transformer substation	25	150
	25	150
	15	90
	300	1800
	130	300
	5	30
Warehouses for raw materials and finished products in accordance with GMP requirements	25	150
TOTAL	845	3530

According to the production program, the capacity of the Enterprise at the first stage will be 2.2 billion units of finished products per year. Subsequently, the capacity of the Enterprise will be increased to 3 billion units of finished products per year with the organization of work in three shifts.

The production program of the Company is fully focused on import substitution, the production of the most modern vital medicines in solid, soft and injectable forms for the treatment of various diseases.

The substance production area at the Enterprise will be built on a modular basis. The modular principle allows the equipment to be reconfigured for the production of a substance of the required type within a few hours. This technological scheme is new not only for Russia, but also for the West.

Design capacities of the Enterprise

The composition of the main equipment

The main manufacturers of equipment for the pharmaceutical industry are traditionally Germany (BOSH, Kilian, Fette), Switzerland (Huber, Zanazi), Italy.

Russian representative offices of large foreign pharmaceutical companies (Hemofarm, KRKA, Pliva), as well as a number of Russian companies, are supplying special equipment.

Conditions and terms of delivery of equipment must be negotiated in each specific case when concluding supply contracts. There is a possibility of acquiring equipment on lease.

Equipment suppliers will be firms determined by the Enterprise on the basis of a tender.

A detailed list and completeness of the necessary equipment should be prepared by the chief technologist of the Enterprise together with the supplier. Below is only a possible list of the necessary equipment with an indication of the maximum allowable price level for it.

List of main equipment

List of additional equipment

Object name	Cost of equipment (without VAT), thousand US$	Cost of start-up and adjustment works (excluding VAT), thousand US$
Plant for the production of water for ampoules	270	30
Complex for water treatment for industrial needs	270	30
Technological equipment for the production of glass ampoules	900	100
Polyethylene bubble production plant	120	13,3
Autonomous boiler room on natural gas	360	40
Transformer substation	150	16,67
Garage for 10 large-capacity vehicles, including auxiliary facilities (repair, washing, diagnostics, etc.)	150	16,67
Office premises (about 3000 m2)	90	10
Scientific - research laboratory	1800	200
Technological laboratory (manufacturing process control)	780	86,67
Premises for security (200 m2)	30	3,33
Equipment for warehouses of raw materials and finished products in accordance with GMP requirements	150	16,67
TOTAL	5070	563,34

conclusions

The projected Enterprise should receive a number of significant advantages compared to similar Enterprises in the region:

full compliance with the rules;
application of the latest technologies in construction;
use of flexible technologies in production;
high power;
use of own cheaper raw materials;
full computerization of the Enterprise;
the possibility of implementing their own developments.

In terms of its capacity, the enterprise should become the largest in the Southern Federal District and enter the top five largest pharmaceutical enterprises in Russia. By the level of its equipment and the use of modern technologies, the Enterprise can take its place among the most modern pharmaceutical plants in Russia and Eastern Europe.

Production and marketing program

Formation of the assortment

The use of flexible technological schemes of production and the use of high-tech equipment will allow the Company to quickly respond to changing market conditions. The marketing analysis of the regional pharmaceutical market, given in Appendix No. 2, made it possible to distinguish the following range of FPPs and substances by pharmacotherapeutic groups and types of FPPs.

To carry out economic calculations on the basis of the above data, the Initiators of the project formed a preliminary range of products of the Enterprise.

Pre-production range

Production

The volume of output when the Enterprise reaches the planned capacity

The table shows output volumes at the following capacity utilization factors: 2005 - 0.6; 2006 - 0.7; 2007 - 0.8.

Price structure. Pricing policy of the Enterprise

Prices for FPP and substances of the Enterprise are set on average 15-20% lower than for similar imported drugs.

Product price

The share of direct costs for drugs produced from purchased substances is taken from the calculation, on average, up to 50% of the selling price. The use of own substances reduces direct costs by 20%. The share of direct costs in the production of substances is, on average, 40% of the cost of production.

Direct unit costs products

Sales volumes. Sales organization

The production and commercial program of the Enterprise is designed for a depth of four years. Taking into account the financial calculations and data obtained as a result of marketing analysis (Appendix No. 2), the Company adopted the following sales volume plan:

For the duration of the project, the Company has developed the following strategy for promoting its products to the pharmaceutical market in Russia and the region:

Advertising

Advertising is an integral part of the successful promotion of the company's products on the market. The purpose of advertising for the advertiser is to bring information to consumers and achieve their location in order to expand demand for the product. According to experts, for a successful advertising campaign, any company needs to go through the following path:

Stages	Actions
Creation of a single concept of an advertising campaign.	It is carried out on the basis of conducted marketing research with the participation of an advertising agency.
Development of thematic and financial plan.	It is compiled by the marketing service of the enterprise for a certain time period, approved by the head.
Development of corporate identity of the enterprise	The main elements of corporate identity: trademark, logo, corporate block (trademark and logo combined into a single composition), etc., creating the company's image.
Media plan development	The choice of media, determining the size, time, place and frequency of placement in it.
Selection of criteria for evaluating the effectiveness of an advertising campaign	Most Russian enterprises most often evaluate the effectiveness of an advertising campaign by how products are sold, foreign enterprises - by conducting surveys that determine who, how often and what kind of advertising has been seen.
Advertising effectiveness analysis, pretest	A preliminary forecast of the effectiveness of the impact of the created advertisement.
Post test	Monitoring the effectiveness of an advertising message, designed to study whether the advertising has achieved its goal and what conclusions can be drawn from the advertising campaign.

The most effective is the testing of advertising products both at the "Launch" stage of the campaign and after its completion. It is necessary to first test the very concept of the planned advertising campaign, and then - its individual elements (videos, printed products). In this case, it also makes sense to test the course of the campaign directly at the stage of its implementation, which allows for prompt correction without interrupting the course of the campaign.

It should be noted the importance of preliminary testing of the advertising campaign and the created advertising material. At this stage, such psychological factors as the frequency of exposure, the environment that really surrounds the advertisement are not taken into account. However, during the pretest, you can first study the perception of the concept of an advertising campaign, the psychological impact of the advertising message, as well as make the necessary changes and additions in accordance with the results of the study.

Clients	Strategic goal		Methods Used
	Sale of FPP	Sale of substances
Dealer firms	Attracting as many target consumers as possible through the deployment of an advertising campaign focused on the optimal price / quality ratio, the existing system of discounts for regular wholesale buyers.	-	Direct mail, presentations, advertising in specialized publications, on the Internet, outdoor advertising.
Pharmaceutical enterprises	-	Attracting as many target consumers as possible through the deployment of an advertising campaign with a focus on the optimal price / quality ratio	Direct mail, participation in exhibitions, meetings, seminars.
State bodies (Ministry of Emergency Situations, Ministry of Health of the Russian Federation, Ministry of Defense of the Russian Federation, Ministry of Internal Affairs)	Receiving government orders	Receiving government orders	Participation in government tenders, competitions, personal contacts.
Population	Attracting as many target consumers as possible through the deployment of an advertising campaign with a focus on the optimal price / quality ratio.	-	Advertising of FPP in mass print media, on the Internet, outdoor advertising, advertising on TV (in specialized programs, videos).

This business plan provides only preliminary estimates and recommendations regarding the promotion of the project. More accurate data should be obtained after the development of the concept of the entire advertising campaign. The approximate stages of the advertising campaign are shown in the table:

Period of activity of the Enterprise	Events	Note
After attracting investment	Signing an agreement with an advertising agency	-
After attracting investment	Development of the concept of the entire advertising campaign of the Enterprise	-
Enterprise construction period	Placement of billboards	-
	Information in printed publications about the Enterprise under construction
	Advertising on the Internet	Advertising on specialized sites on the Internet
After the commissioning of the enterprise	Advertising in specialized magazines	"Remedium", "Farmarket", "Health"
	Creation of the Enterprise website on the Internet	-
	Creating a video for TV	-

According to expert estimates, the cost of developing and conducting an advertising campaign for an enterprise can be about 3% of the sales volume.

Methods of winning and retaining customers

The cost of developing and implementing sales promotion and customer retention measures is about 2% of the sales volume.

The ability to win and retain customers is becoming an increasingly popular weapon in the competition among the most "intelligent" companies. Programs to encourage regular customers are concretely embodied in the manufactured products and the prices set for them. As the century unfolds, the struggle between companies seeking to wrest and retain each other's most attractive customers will become even fiercer.

Customer retention is a dynamic concept, dependent on investments made over time and steps taken over time. To understand and solve the problem of customer retention, it is necessary to predict the possible development of events from the very beginning.

According to international experts (Karl Shapiro - Professor at the Haas School of Business at the University of California, Berkeley, www.inforules.com), the popularity of loyalty programs is growing every year. Preference will be given to "deserved" customers, and the cost of switching to another supplier will increase.

Reward programs are much easier to run when companies have information about the consumer behavior of their customers. Already, many trading companies are collecting information about the preferences of their customers. These methods involve tracking purchases made over a certain time by specific customers, and a separate column should be entered for each customer. With the development of information technology, the processing of such information is becoming cheaper, and more and more companies (including quite small ones) believe that the cost of analyzing consumer behavior is justified.

Today we can already say that the most complex information systems and targeted promotional activities are becoming weapons in the competitive struggle. This weapon replaces traditional techniques: giving products a spectacular appearance and pricing policy.

A brief description of the methods aimed at retaining customers by the Enterprise

Method	Description of the method
Formation of the client base.	Client bases are formed for each of the types of core business of the Company (sale of FPP and sale of substances) using modern computer programs.
Offering a wide range of manufactured FPPs and substances to the client	The Marketing Department of the Company constantly monitors the changing market conditions. Gives recommendations on the formation of a product range.
System of discounts for wholesale buyers.	For wholesale buyers, a special system of discounts for purchased FPPs is applied, depending on the size of the purchased batch of goods, assortment.
The use of various benefits and bonuses when working with regular customers.	The use of various discount, accumulative cards in customer service.

organizational plan

Stages and terms of project implementation

Name	Duration (days)	start date	expiration date	Responsible
Preparatory stage	302	01.06.2002	29.03.2003
Business plan preparation	30	01.06.2002	30.06.2002	ZAO IK "Contrast"
	30	01.06.2002	30.09.2002
Getting a land plot	30	15.07.2002	13.08.2002	LLC "Media-Rost"
IRD preparation	60	01.08.2002	29.09.2002
	60	01.08.2002	29.09.2002
	180	01.10.2002	29.03.2003
Construction of FFS shops and auxiliary production	736	01.05.2003	05.05.2005	general contractor
Advance payment 30%		01.05.2003	05.05.2003	Adjustments to the construction payment scheme are possible in agreement with the general contractor
Payment 1		01.07.2003	05.07.2003
Payment 2		01.09.2003	05.09.2003
Payment 3		01.11.2003	05.11.2003
Payment 4		01.01.2004	05.01.2004
Payment 5		01.03.2004	05.03.2004
Payment 6		01.05.2004	05.05.2004
Payment 7		01.07.2004	05.07.2004
Payment 8		01.09.2004	05.09.2004
Payment 9		01.11.2004	05.11.2004
Payment 10		01.01.2005	05.01.2005
Payment 11		01.03.2005	05.03.2005
Payment 12		01.05.2005	05.05.2005
Order and supply of equipment	3603603603	01.05.2004	01.05.2005	LLC "Media-Rost"
Advance payment for equipment-50%		01.05.2004	05.05.2004
Equipment payment		01.05.2005	05.05.2005
	185	01.05.2005	01.11.2005	general contractor
Start of FPP production	-	01.11.2005	-	LLC "Media-Rost"
Construction of organic synthesis lines	730	01.05.2003	29.04.2005	general contractor
Order and payment for equipment for organic synthesis	366	01.05.2004	01.05.2005	LLC "Media-Rost"
Commissioning works	185	01.05.2005	01.11.2005	general contractor
Purchase of technologies	90	01.05.2005	29.07.2005	LLC "Media-Rost"

According to the presented schedule, the final validation of the plant can be started in the 3rd quarter of 2005.

Management team

Top managers of the Company include:

No. p / p	FULL NAME. job title	Tasks, functions, responsibility	Education, work experience in the field
1.	General Director – Glubokov Vladimir Alekseevich	Enterprise management	Higher technical, retraining "Anti-crisis management of an enterprise", certificate of an anti-crisis manager of the II category
2.	Deputy CEO Khristin Eduard Konstantinovich	Enterprise management	Higher
3.	Professional Advisor - Anatoly Kuzmich Brel		Higher degree, chemical engineer, technologist, second higher education - pharmacist. Doctor of Chemistry, Professor, Dean of the Faculty of Pharmacy, Head of the Department of Chemistry of the Volgograd State Academy of Architecture and Civil Engineering, full member and member of the Presidium of the Russian Academy of Natural Sciences, author of more than 200 inventions for the pharmaceutical industry.
4.	Economic Adviser - Vadim Nikolaevich Kabanov		Degree in economics. Doctor of Economics, Professor of the Volgograd State Academy of Architecture and Construction, full member of the International Academy of Investments and Construction Economics, author of more than 100 publications.

Production personnel

In accordance with international standards, the staff of a pharmaceutical enterprise of this level should be about 3 thousand people, and, as a rule, a fifth of the employees should have a diploma of higher specialized (chemical-pharmaceutical) education. Employees must constantly improve their skills. The training project for the employees of the Enterprise must be drawn up in accordance with the world quality standards of the ISO9000 series. To do this, it is necessary to provide special premises where training of new employees, trainees, quality controllers and advanced training of managers of the Enterprise will take place.

Project implementation partners

The main partners of the Enterprise for the implementation of the project are:

No. p / p	Partner	Project Needs
1.	Administration of the Volgograd region and the Soviet district of the city of Volgograd	Allocation of a land plot for the construction of the Enterprise
2.	International Academy of Investments and Construction Economics	Economic calculations and development of an enterprise development strategy
3.	Volgograd State Academy of Architecture and Civil Engineering	Scientific and technological implementation of the project
4.	ZAO IK "Contrast"	Marketing research, external economic environment forecast, project risk analysis, business plan development
5.	Hemofarm Co.	Design, construction and installation and commissioning works

Tasks of organizational building

Among the priority tasks of organizational building, the management of the Enterprise identifies the following:

High-quality preparation of pre-project documents.
Establishing reliable professional relationships with the management of Hemofarm, financial partners, suppliers of special and industrial equipment.
Formation of the core of the main managers of the Enterprise.
Invitation of foreign managers for the period of debugging and start-up of production.

Financial plan

Investment project financing

Project participants

The date - 06/01/2002 was taken as a conditional date for the start of the project.

The period for calculating the effectiveness of investments is 90 months from the start of the project.

Share capital structure

Shareholder 2 makes the first contribution to the authorized capital in the 1st month of the project. The remaining amounts are paid according to the scheme, covering the shortage of funds during the entire construction of the Enterprise.

State support in the form of a loan is provided to the Enterprise starting from the 24th month of the project at the stage of completion of construction.

State support in the form of a loan

Name	date	Amount ($US)	Term	Bid(%)
Loan amount	01.05.2004	29 101 445,61	26 months	13

Investment costs, thousand US$

Line	3 sq. 2002	4 sq. 2002	2003	2004	2005 year
Solving the problems of the municipality	500
Business plan preparation	20
Allotment of land	500
IRD preparation	250
Development of an architectural concept	250
Development of construction documentation		2718
Obtaining all kinds of permits, licensing	5000
Consulting	1260
Advance payment			2534,4
Payment 1			400
Payment 2			400
Payment 3			400
Payment 4				400
Payment 5				400
Payment 6				400
Payment 7				400
Payment 8				400
Payment 9				400
Payment 10					400
Payment 11					400
Payment 12					1513,6
Reserve -10% of the cost of construction					3000
Advance payment for equipment
Equipment payment					8154
Installation, adjustment, start-up of equipment					1811,9
Purchase of technologies					3000
TOTAL	7780	2718	3734,4	10554	18279,5

Income of project participants

Taxation

Since January 1, 2002, a 10% VAT was established for the pharmaceutical industry (for all medicines and medicinal substances without exception). As a result of the introduction of 10% VAT, drug prices increased by 14-16%. However, it should be kept in mind that the 10% VAT on medicines is most likely a temporary phenomenon, and by 2003 the tax could be increased to 15%.

A serious factor in curbing the growth of prices for medicines is the reduction in the number of intermediaries in the chain from the manufacturer to the consumer. In the future, it can be expected that the growth of ruble prices for medicines will be approximately equal to the VAT rate + % of monthly inflation in the country.

Tax rates used

Project performance indicators

The period for calculating performance indicators is 90 months.

Project risk assessment

The main risks of the project

Project risk analysis can be subdivided into qualitative (description of all expected project risks, as well as assessment of their consequences and mitigation measures) and quantitative (direct calculations of changes in project efficiency due to the implementation of certain risks). A detailed description of the methodology and the results of the risk assessment are given in Appendix No. 4 to the business plan.

Qualitative risk analysis

The proposed scenario for the implementation of the investment project covers several fairly well-defined stages, so it is advisable to carry out a qualitative risk assessment by project stages.

One of the methods of qualitative risk analysis that affects the feasibility of the project is the method of stage-by-stage risk assessment proposed by Lipsits I.V. and Kossov V.V.

In this methodology, risk is understood as the danger that the goals set in the project may not be partially or completely achieved.

In the considered investment project, the following periods and stages are distinguished:

1. Preparatory period.

1.1. Research and development.
1.2 Allocation, purchase or lease of a land plot.

2. Construction and installation of equipment.
2.1 Construction, rental or acquisition of buildings and structures.
2.2 Acquisition and installation of technological equipment.

3. Licensing and certification of pharmaceutical production.

4. Production and marketing (sales of products).

Staged risk assessment is based on the fact that the risks are determined for each period or stage of the project separately, and then the total risk for the entire project is found.

The investment project under study is individually developed, which, in essence, leaves the only possibility for assessing the risk values - an expert assessment. The experts of the project developers acted as experts, and the opinions of specialists working in the pharmaceutical and construction industries were also taken into account.

Appendix No. 6 describes the actions taken by the Project Initiators for its implementation, as well as assessments of simple risks with and without taking into account these actions. The risk assessment of the project as a whole was also carried out for two options: with and without taking into account the actions already taken by the Project Initiators aimed at reducing the consequences and the likelihood of risks. It was found that the total risk of the project was:

28.4% - without taking into account the actions of the Project Initiators;
20.6% - taking into account the actions of the Project Initiators.

The tables below show the results of project risk assessment by periods (stages) of implementation and by groups of simple risks.

Risk assessment by project implementation periods<_o3a_p>

Periods and stages	Risk (without taking into account the actions of the Initiators)	Risk (taking into account the actions of the Initiators)
Preparation period	8,6%	5,5%
Research and development	6,2%	3,7%
Allocation, purchase or lease of land	2,3%	1,7%
Construction and installation of equipment	5,8%	4,6%
Construction, rental or acquisition of buildings and structures	4,2%	3,1%
Acquisition and installation of technological equipment	1,6%	1,5%
Licensing and certification of pharmaceutical production	2,9%	2,1%
Production and marketing (sales of products)	11,1%	8,4%
In general, for the project	28,4%	20,6%

Project risk assessment by groups

Quantitative risk analysis. Sensitivity analysis

The task of quantitative analysis is to numerically measure the impact of the implementation of certain risk factors on the effectiveness of the project.

The most common quantitative method of risk analysis is the sensitivity analysis of project performance indicators.

The wider the range of parameters in which the performance indicators remain within acceptable values, the higher the “margin of safety” of the project, the better it is protected from fluctuations of various factors that affect the results of the project. The study of the sensitivity of the project to possible changes in parameters was carried out using the computer software system Project Expert 7.01 by Pro-Invest IT.

As integral indicators characterizing the financial result of the project, when assessing the sensitivity, cash flow parameters are used, namely:

profitability index (PI);
internal rate of return (IRR);
net present value of income (NPV).

The table below shows the factors that varied during the sensitivity analysis and the range of their change, as well as the calculated values of the integral indicators.

Sensitivity analysis

Parameter\Range	-20%	-10%	0%	10%	20%

Tax rates	3,06	2,94	2,83	2,72	2,62
Investment size	3,4	3,08	2,83	2,61	2,43
Sales volume	2,2	2,51	2,83	3,14	3,46
Sales price	1,69	2,26	2,83	3,41	4
direct costs	3,36	3,09	2,83	2,57	2,31
General costs	2,9	2,87	2,83	2,79	2,76
Salary	2,9	2,87	2,83	2,79	2,75
Loan rate	2,85	2,84	2,83	2,82	2,81

Tax rates	146,1	137,88	129,97	122,36	115,04
Investment size	139,55	134,76	129,97	125,17	120,38
Sales volume	85,07	107,52	129,97	152,41	174,86
Sales price	49,88	89,93	129,97	170,01	210,05
direct costs	165,16	147,56	129,97	112,37	94,77
General costs	133,71	131,84	129,97	128,09	126,22
Salary	135,05	132,51	129,97	127,42	124,88
Loan rate	130,46	130,21	129,97	129,72	129,48

Tax rates	31,92	30,82	29,73	28,65	27,57
Investment size	35,95	32,63	29,73	27,18	24,9
Sales volume	21,93	26,03	29,73	33,11	36,23
Sales price	14,34	22,81	29,73	35,63	40,79
direct costs	35,02	32,46	29,73	26,81	23,66
General costs	30,4	30,07	29,73	29,4	29,06
Salary	30,55	30,14	29,73	29,32	28,9
Loan rate	29,88	29,81	29,73	29,66	29,59

An analysis of the sensitivity of integral performance indicators to changes in various factors characterizing the project shows that project indicators depend to the greatest extent on:

sales prices of products;
sales volumes;
direct costs;
volume of attracted investments.

To the least extent of the factors considered, the project performance indicators are affected by:

change in payroll costs;
the interest rate on the borrowed loan.

The most critical integral indicator of the project's effectiveness is the internal rate of return IRR, which decreases to 14% with a 20% decrease in the selling price of products. In general, the sensitivity analysis indicates that the project is sufficiently resistant to adverse changes in the considered factors.

Risk Mitigation Methods

The table below shows the main risks of the investment project and recommended measures to reduce them.

simple risk	Wi	Measures to prevent risks and reduce the consequences of their implementation
Negative change in the political situation in the country	1,2%
Negative change in the economic situation in the country	1,2%	Monitoring and forecasting the development of the economic and political situation in the Russian Federation. Optimization of financing schemes.
High competition among manufacturers of similar products	1,0%	Implementation of flexible technological schemes of production, allowing to quickly adapt to changing market conditions. Improving the functioning of the marketing departments of the enterprise.
Inability to provide the Enterprise with raw materials of the required quality at affordable prices	0,8%	Optimization of the scheme for providing the enterprise with raw materials and supplies. Transition to cheaper raw materials and materials, including the replacement of imported materials with domestic ones. Optimization of technological processes and production schemes, creation of reserves and stocks of raw materials and materials. Cost reduction. Establishment of long-term cooperation with suppliers, participation in the share capital of enterprises - suppliers.
Lack of demand for the Company's products	0,8%	Market monitoring. Improving the functioning of the marketing departments of the enterprise.
Opposition from representatives of the authorities	0,72%
Loss of control over the Enterprise	0,68%	Development and implementation of protection strategies, including protection against takeovers and retention of a controlling stake in the enterprise.
Lack of experience of the project initiators for its implementation	0,6%	Involvement of experienced managers and consultants for the implementation of the project.
Lack of companies that are ready to perform construction work and have the required level of qualification and experience in the construction of modern pharmaceutical enterprises	0,6%	Involvement of foreign companies with the required level of qualification and experience in the construction of modern pharmaceutical enterprises.
Expensive and complicated procedure for licensing and certification of production	0,6%	The optimal choice of the range of manufactured products, corresponding to the real possibilities of the enterprise to obtain the appropriate licenses. Attracting experienced lawyers and specialists to obtain the appropriate licenses, lobbying.
High cost of delivery of raw materials	0,6%	Optimization of the scheme for providing the enterprise with raw materials and supplies. Implementation of promising schemes for the delivery of raw materials and materials.
The prospect of curtailing the market in the short or medium term, reducing effective demand	0,6%	Introduction of flexible technological schemes of production. Improving the functioning of the marketing departments of the enterprise. Market monitoring.
Unrealizable (unworkable) project idea	0,6%	Additional elaboration of the project idea. Careful selection of consultants.
Intervention of the state or legal institutions in the process of production and distribution of products	0,6%	Optimization of financing schemes. Creation of a competent legal service at the enterprise. Establishing partnerships with government agencies.
Illegal actions against the Company, falling under the influence of criminal structures	0,5%	Maximum information openness of the project, maximum use of legal schemes, including financing and marketing in the course of project implementation. Careful selection of contractors and partners. Involvement of competent specialists to solve emerging problems. Development and implementation of protection strategies, including protection against takeovers and retention of a controlling stake in the enterprise.
Absence of local building materials and increase in the cost of the project due to the high cost of their delivery to the construction site	0,5%	Optimization of the scheme for providing construction materials. Switching to cheaper materials, including the replacement of imported materials with domestic ones. Optimization of construction, creation of reasonable reserves and stocks of building materials.
Lack of technical and/or technological capability to implement the project	0,4%	Additional elaboration of the project idea and the concept of its implementation. Careful selection of consultants.
Lack of qualified specialists who can be employed in production	0,4%	Search and attraction of necessary specialists, including abroad. Development of a program for targeted training of specialists.
Lack of working capital	0,4%	Creation of reserves. Development of a system of measures to reduce the company's need for working capital by increasing the rhythm of work, reducing stocks, and working with debtors.
Insufficiency of own funds of the Project Initiators to finance pre-project studies and overhead costs	0,4%
Inability to ensure profitable operation of the Enterprise in specific economic conditions	0,4%	Additional elaboration of the project idea and the concept of its implementation, development of the financial model of the project. Careful selection of consultants.
Inability to select and/or obtain on acceptable terms a land plot that meets the requirements for pharmaceutical production enterprises	0,4%
Lack of qualified scientific personnel, underdeveloped scientific base or inability to establish partnerships with the local scientific community	0,4%	Establishment of partnership relations with specialized scientific organizations and higher educational institutions. Involvement of specialists from other regions of the Russian Federation, as well as other countries.
The Project Initiators do not have their own funds for the purchase or lease of a land plot	0,4%	The use of various schemes for attracting financial resources, including borrowed and equity. Search for investors and creditors.
Lack of financial resources to pay for the construction, rent or purchase of buildings	0,4%	The use of various schemes for attracting financial resources, including borrowed and equity. Search for investors and creditors.
Lack of funds for the purchase and installation of equipment	0,4%	The use of various schemes for attracting financial resources, including borrowed and equity. Search for investors and creditors.
Stricter requirements for ensuring the safety of production and storage of pharmaceutical products	0,4%	Optimization of the product range and technology of its production; storage and transportation of raw materials and products, taking into account the specific requirements for the organization of pharmaceutical production and ensuring its safety.
Major accidents, fires	0,3%	Improving the system for ensuring the safety and control of construction, production, storage and transportation of raw materials and finished products, the use of various risk insurance schemes.
Counteraction of competitors	0,14%	Development of own brands, optimization of production technology - identification and formation of competitive advantages of the Enterprise.
Lack of a piece of land that meets environmental requirements	0,1%	Search for alternative options for locating the enterprise, including in other regions of the country.
Lack of funds for licensing and certification of pharmaceutical production by the Project Initiators	0,1%	The use of various schemes for attracting financial resources, including borrowed and equity. Search for investors and creditors.
Rising cost of resources in the capital market	0,08%	The use of various schemes for attracting financial resources, including borrowed and equity. Search for investors and creditors. Development of alternative financing options, including through the issuance of corporate shares and bonds.
Natural disasters	0,06%	Improvement and optimization of the system for ensuring the safety and control of construction, production, storage and transportation of raw materials and finished products, the use of various risk insurance schemes.
Energy issues	0,05%	Introduction of energy-saving technologies. Search for alternative options for providing production with energy. Creation of own subdivisions to provide the enterprise with energy. Equity participation in the share capital of energy enterprises.
Opposition from public organizations	0,04%	Using the media to create a favorable image of the Company
Default by creditors or investors	0,04%	Attracting various investors and lenders. Optimization of financing schemes and improvement of contractual relations. Creation of a competent legal service at the enterprise.
Lack of skilled labor for construction and installation of equipment	0,04%	Establishing cooperation with educational institutions of the relevant profile. Attracting qualified specialists from other regions of the country and neighboring countries.
Consumer insolvency	0,03%	Market monitoring. Entering new markets. Implementation of technological schemes in production, allowing to quickly adapt to changing market conditions. Improving the functioning of the marketing departments of the enterprise.

conclusions

1. A qualitative risk analysis made it possible to identify the main risks of the project and assess both the likelihood of their implementation and the probability of project failure when each simple risk is realized. Estimates of project risk reduction as a result of the work performed by the Initiators in the pre-investment period of the project were obtained. The risk assessment for the project as a whole is 28.4%, and taking into account the work performed by the Project Initiators - 20.6%.

2. The greatest threat to the project is technological, marketing, financial, economic and socio-political risk groups. The most risky are the preparatory period and the period of production and marketing (sales of products).

3. The most dangerous for the successful implementation of the project are the following simple risks:

negative change in the political and economic situation in the country;
high competition among manufacturers of similar products.
loss of control over the Company;
inability to provide the Enterprise with raw materials of the required quality at affordable prices;
lack of demand for the Company's products;
opposition from representatives of the authorities;
the lack of companies that are ready to perform construction work and have the required level of qualification and experience in the construction of modern pharmaceutical enterprises;
expensive and complicated procedure for licensing and certification of production;
high cost of delivery of raw materials;
the prospect of curtailing the market in the short or medium term, reducing effective demand;
intervention of the state or legal institutions in the process of production and distribution of products.

4. Sensitivity analysis showed that to the greatest extent project performance indicators (PI, IRR, NPV) depend on:

sales prices of products;
sales volumes;
direct costs;
volumes of attracted investments.

In general, the results of the sensitivity analysis indicate that the project is sufficiently resistant to adverse changes in the considered factors.

List of sources used

Order of the Ministry of Health of the Russian Federation and the Ministry of Economy of the Russian Federation of December 3, 1999 No. 432/512 "On the Enactment of the Industry Standard OST 42-510-98 "Rules for the Organization of Production and Quality Control of Medicines (GMP)". Order of the Ministry of Health of the Russian Federation of November 1, 2001 No. 388 "On State Quality Standards for Medicinal Products" State Register of Prices for Medicinal Products (10th edition, as of November 5, 2001) Decree of the Government of the Russian Federation of November 9, 2001 No. 782 "On State Regulation prices for medicines". Order of the State Customs Committee of the Russian Federation and the Ministry of Health of the Russian Federation dated August 13, 2001 No. 792/321 "On Approval of the Regulations on the Procedure for Customs Clearance of Medical Goods, Raw Materials and Components for Their Production Using a Special Procedure for Declaration of Goods". Orlov A. I. Strategic management, 1998 http://www.akdi.ru/econom/program/ V. Boikova, F. Fili, I. Sheiman, S. Shishkin "Public participation in health financing" http://rcc .ru/Eng/Pharmaceuticals "VAT on medicines increases the cost of medicines." http://ad.ir.ru Academy “Civil Society. Analytics." http://verofarm.ru Veropharm is switching to the production of generics. http://www.remedium.ru/news "KRKA has opened one of the most modern pharmaceutical plants in the world." http://www.dsm.ru/st1.htm "General issues of information support for the pharmaceutical business". http://www.remedium.ru/news "Construction of a pharmaceutical plant LLC "Krka RUS" is underway in the city of Istra, Moscow Region.". http://www.pharmvestnik.ru/ISSUES/0162 "Pharmaceutical industry of France". http://www.remedium.ru "The French drug offensive continues." http://www.pharmateca.ru/№299/P14.htm "ISO 9000 series standards - perspectives of application in pharmaceutical industry". http://www.remedium.ru Generics. World Trends and Russian Reality”. http://www.remedium.ru "Quality of substances and GMP rules - imaginary incompatibility". http://www.remedium.ru/business/pharm/analysis/manuf/china.asp "China is the birthplace of pharmaceutical substances". http://www.remedium.ru/business/pharm/analysis/regrev/0012.asp "The influence of state regulation on the development of regional models of the pharmaceutical market". http://www.remedium.ru "Reviews of drug markets". http://www.remedium.ru/business/pharm/analysis/manuf/mbmfr99.asp “Production of drugs. Microbiological industry of Russia. http://www.remedium.ru/business/pharm/analysis/manuf/rem00115.asp “Drug production. Ensuring “pharmaceutical” quality”. http://www.remedium.ru/business/pharm/analysis/regrev/ph_deutch.asp "German Pharmaceutical Firms in the Russian Market". Magazine "Remedium" №1-12, 2001 http: //www.remedium.ru. "Forecast of the production of pharmacological preparations in Russia in 2002. "Profile" 21.01.02 http://www.marketsurveys.ru/s01005066.html. On the Russian pharmaceutical market. Izvestiya 26.01.02 http://www.marketsurveys.ru/s01005098 .html Russian Pharmaceutical Market http://www.marketsurveys.ru/s0100669.html JSC Nizhpharm http://www.nizhfarm.ru JSC Biosintez http://www.remedium.ru/ business/pharm/analysis/dossier/biosintez/index.asp JSC "Irbit Chemical-Pharmaceutical Plant" http://www.remedium.ru/business/pharm/analysis/dossier/irbithfz/index.asp JSC "Vostok" http://www.remedium.ru/business/pharm/analysis/dossier/irbithfz/index.asp ://www.vostok-kirov.ru/ .Largest foreign firms-suppliers.Largest firms importing medicines to Russia.Drugs - leaders in imports.http://www.pharmateca.ru/new/RFP12000.htm. Fight against counterfeit medicines in Russia" http://www.pharmateca.ru/2001/№2001.11/falsification.htm. "Import of medicines to the regions" http://www.pharmateca. Analytical materials. http://www .remedium.ru/business/pharm/analysis/index.asp "The influence of state regulation on the development of regional models of the pharmaceutical market". http://www.remedium.ru/business/pharm/analysis/regrev/0012.asp Thematic reviews. http://www.remedium.ru/business/pharm/analysis/reviews/index.asp Regional reviews. http://www.remedium.ru/business/pharm/index.asp Analytical materials http://www.remedium.ru/business/pharm/analysis/index.asp Present and future of Russian substances. http://www.remedium.ru/business/pharm/analysis/manuf/now.asp Healthy business. http://www.cfin.ru/press/boss/2001-09/06.shtml Domestic narcotic drugs. http://www.remedium.ru/business/pharm/analysis/drugrev/0036.asp Methods for assessing the capacity of regional pharmaceutical markets. http://www.remedium.ru/business/pharm/analysis/regrev/reg_appreciate.asp "Production of high-tech medicinal substances". http://www.marketsurveys.ru/s01004689.html. "The use of marketing elements in the practice of a modern pharmacy". http://www.remedium.ru/business/pharm/analysis/market/ra0016.asp. "Strategy of assortment formation". http://www.remedium.ru/business/pharm/analysis/retail/ra0014.asp "Analysis of price changes in connection with the introduction from January 1, 2002 VAT on FPP". http://www.remedium.ru/business/pharm/analysis/retail/vat.asp.

Applications

Appendix No. 1 "Preliminary marketing analysis".

Appendix No. 2 "Strategic goals and main tasks of the Enterprise".

Appendix No. 3 "Analysis and forecast of the external economic environment."

Appendix No. 4 "Analysis of project risks and methods for their reduction."

Appendix No. 5 "Detailed financial plan".

Business plan for the production of dosage forms. Business plans in medicine and pharmaceuticals

How is a pharmaceutical business organized on the Internet

Who buys pills online

Making money on the farm - why you should try

Send your good work in the knowledge base is simple. Use the form below

Similar Documents

Summary

Goals and objectives

Mission of the Enterprise, main goals and objectives of the project

Project initiators

Entrepreneurial intent

Significance of the Enterprise for the state and the region

Marketing Analysis

State of the domestic pharmaceutical market

Russian medicines

Production of substances

Imported medicines

Description of the geographic segment

Peculiarities of FPP consumption in the region

Analysis of the pharmaceutical market in the region under consideration

Market segmentation

Analysis of market segments by types of business

Analysis of market segments by product types

Analysis of the regional market by pharmaco-therapeutic groups of drugs

Share of products in the total market volume

Competitive Analysis

Competing enterprises

Analysis of competitive forces

SWOT analysis

Key Success Factors

KFU

conclusions

Company Description

Corporate requirements for the organization of pharmaceutical production

Land plot

The main characteristics of the created production

The composition of the main equipment

conclusions

Production and marketing program

Formation of the assortment

Production

Price structure. Pricing policy of the Enterprise

Sales volumes. Sales organization

Advertising

Methods of winning and retaining customers

organizational plan

Stages and terms of project implementation

Management team

Production personnel

Project implementation partners

Tasks of organizational building

Financial plan

Investment project financing

Taxation

Project performance indicators

Project risk assessment

The main risks of the project

Qualitative risk analysis

Quantitative risk analysis. Sensitivity analysis

conclusions

List of sources used

Applications

Popular