Investment project

A. Project Opportunity Description:

Al. Project Name: Set up of manufacturing drugs in Soft and Hard Gelatin Capsules at MINSKINTERCAPS UV
a. Short name: Set up of manufacturing drugs in gelatin capsules
b. Full name: Set up of manufacturing drugs in Soft and Hard, output 500.0 mln capsules per year
c. Summary description: Production set up with the aim to increase output of finish dosage forms in gelatin capsules meeting the requirements of GMP; to satisfy public demand of top-quality products and further output increase of import substituted drugs, to maintain and expand the market in CIS members.

A2. Progress Status:
Investment project Development of business-plan
Available plot of land of 13,000.0 M3 at the address: 26 Inzhenernaya st., Free Economic Zone MINSK

A3. Organizations involved and their roles:
MINSKINTERCAPS U.V. 26 Inzhenernaya st,, 220075-Minsk
Mr.Bondarev Andrey Vasilievich-Director
Decision-making authority
Tel./fax: (+375 17)3445623
Mr.Ladutko Igor Victorovich-Chief Engineer Solution of technical issues
Tel./fax: (+375 17)3445633
E-mail: info@mic.by www.mic.by

A4. Project Description:
     Realization of investment project provides the foundation of the production of drugs in gelatin capsules meeting the requirements of respective national and international rules of Good Manufacturing Practice (GMP). The production under foundation is completely mechanized and robotized that consents to increase product quality and its consuming characteristics. Project realization consents to increase product competitiveness, to maintain, and also to increase the quantity of drugs supplied for export that assures the rise of currency incomes.
     This investment project can be completely modified subject to the available actual offers of the investor.
A4a. Project cost (mln USD): 20.0

A5. Background / history / overall programm / related or similar projects:
     MINSKINTERCAPS launched its manufacturing activity in 1995. In 2003 Manufacturing Republican Unitary Venture MINSKINTERCAPS became member of Belarusian State Concern for manufacturing and marketing of pharmaceutical and microbiological products (BELBIOPHARM).
     Currently the list of manufactured drugs is more than 50 positions; the enterprise manufactures also biological active food additives; Hard Gelatin Capsules. MINSKINTERCAPS U.V. is located in the territory of more than 2.3 ha.
The area of free-standing buildings and structures is 5,840. M2.
Production facilities: 2,119. M2.
Storage rooms: 825 M2.
Chemico-microbiological laboratory: 245 M2. 

      Production facilities of the factory: Empty Hard Gelatin Capsules: 400 mln capsules per year.
Production of drugs in HGC: 185 mln per year.
Production of drugs in SGC: 225 mln per year.
     New drugs have been introduced to the production by specialists of R&D and Registration department. The factory has chemico-microbiological laboratory equipped with all the necessary devices for QC of drugs in full compliance with the requirements of normative technical documentation at each stage of the technological process of the product manufacturing.
     The main scope - the production of drugs is assured by the following units:
- Production department: production line for hard gelatin capsules and production line for soft gelatin capsules;
- Mechanical-repair shop (manufacturing of accessories for the equipment, press-instruments, tooling, new equipment assembly)
- Power engineering department (power supply, utilization and due repair of power equipment)
- Chemico-microbiological laboratory of MINSKINTERCAPS U.V. is certified for technical expertise in accordance with the requirements of STB ISO/MEK 17025-2007.
- Number of employees: 284. 

      Quality Certificates:
- Quality Management System in compliance with STB ISO 9001-2009 has been implemented and maintained since 2000 at the enterprise MINSKINTERCAPS U.V.
- The production of biological active food additives in soft and hard gelatin capsules is certified by BALTCERT for the compliance to the requirements of EC Commission Regular (EC) N.852/2004.
- The production of drugs in hard and soft gelatin capsules, of hard gelatin capsules meets the requirements of STB 1435-2004 and TKP 030-2006 Good Manufacturing Practice (GMP).
     MINSKINTERCAPS U.V. was granted the Certificate of Compliance of Occupational Safety and Health Management System to the requirements of STB ISO 18001-2005, and Ecological Certificate meeting the requirements of STB ISO 14001-2005.
     Production in 2008: USD 10.5 mln.
     Drug output: 8.6 mln of packs.
Currently the main task of the team is the construction of a new building for further development. It implies the development of business-plan of the investment project. The investment costs for the construction are estimated at the amount of approx.USD 20 mln. To realize this project there’s land available in the territory of MINSKINTERCAPS U.V. The factory is interested in engaging investor to make contribution to authorized capital of the enterprise under foundation, and further, to make an offer on the production of highly effective drugs.
The factory is ready to study the offer of eligible investment for the production of drugs at MINSKINTERCAPS U.V.
The financial standing of the factory is stable.
The index of current liquidity: 2.68 The index of financial security of own funds: 0.02. Profitability of realized products within January/June: 25.3%.

A6. Environmental impact summary: Negative impact on the environment is not subject to modern technology and equipment of commissioning.

A7.Possible obstacles / problems / risk assessment:
Possible disadvantages of project implementation can be classified as follows:
- raw and material price increase
- additional investment costs out of the project
- product registration and certification problems in foreign market

A8. Term of realization / term of recoupment (years): 3-4 years

A9. Project’s branch: Pharmaceutical industry

                                                         H. Project information source:

H1. This form was completed by:
Director of MINSKINTERCAPS U.V. Mr.Bondarev Andrey Vasilievich
for contacts: English speaking person Mrs.Tsarik Natalia Sergueevna, secretary-adviser

H2. Organization (address):
MINSKINTERCAPS U.V. 26 Inzhenernaya st., 220075 Minsk, Republic of Belarus

H3. Tel / Fax / E-mail:
Reception Tel./fax: (+375 17)3445623
E-mail: info@mic.by www.mic.by

H4. Date: October, 2009

H5. Supreme organization: Belarusian State Concern for manufacturing and realization of pharmaceutical and microbiological products (concern BELBIOPHARM)