Manufacture
Obninsk Chemical and Pharmaceutical Company CJSC
High quality of a product is possible only with constant monitoring of all stages. Therefore, we carry out full-cycle pharmaceutical development projects, starting from the synthesis of pharmaceutical substance from high-quality raw materials and ending with the drug product manufacture.
Our focus is the development of high technology with their further use in the manufacture of substances and drug products. As a result, we manufacture complex drug products on a cycle “from the flask” to industrial scales, ensuring high quality, controlled cost and independence from regular deliveries from foreign markets.
Green focus
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We save water
There is practically no sewage water in the technological process, as water is used only to moisten a tablet mass, which further evaporates during granule drying
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We control the tightness
During the technological process, the equipment with hermetically sealed containers (is used)
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We exclude dispersion
Transportation of raw materials in the form of powder and granules in production facilities is carried out in closed containers that exclude dispersion
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We clean the air
The air from the equipment is cleaned before being discharged into the atmosphere
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We monitor cleanliness
Wastes from production stages are collected and disposed of
We manufacture
- Tablets
- Coated tablets
- Soft capsules
- Hard capsules
In addition to substances and finished dosage forms for our own needs, we produce them for partners on the basis of contract manufacture. Learn more
The main customers for the contract manufacture are Nizhpharm (STADA CIS) and Valenta Pharm.
Under contracts with Valenta Pharm, we produce substances and finished drug products in the form of tablets, including the substance Vitaglutam® for the antiviral agent Ingavirin®.
Under contracts with Nizhpharm, we produce drug products with the trade names Mexiprim®, Ginepriston®, Ginestril®, Miropriston®, Mirolut®, Tranexam®.
On a contract basis, (in our laboratories) we develop active pharmaceutical ingredients and finished drug products, scale technologies to an industrial level, create all the necessary regulatory documents and registration dossiers, including the analytical part.
- Czech Republic - development and manufacture of pharmaceutical substances and control methods, commercial manufacture of pharmaceutical substances.
- Latvia - development of injectable dosage forms and control methods, commercial manufacture of injectable dosage forms (products are sold in Europe and the World - more than 40 countries).
GMP Certificates
Science
Mirpharm group of companies implements projects on full cycle pharmaceutical developments in Russia and abroad.
Our possibilities
- own R&D departments in the Russian Federation and the EU;
- own production of substances in the Russian Federation and the EU;
- own production of finished drug products in the Russian Federation and the EU;
- two-way transfer of analytics and technology (from the RF to the EU, from the EU to the RF);
- more than 18 years of practical experience of our own development, registration and introduction into the manufacture.
Substances
- development of technologies for the synthesis of substances;
- scaling to an industrial level;
- development and validation of control methods;
- creation of ASMF in CTD format;
- creation of regulatory documentation (RF, EAEU);
- support of the registration process;
- commercial production of substances at Mirpharm sites (RF and EU);
- technology transfer to the customer’s site.
Finished dosage forms
- development of the finished drug products formulations (solid, liquid);
- scaling to an industrial level;
- development and validation of control methods;
- creation of registration dossiers in CTD and EAEU formats;
- conducting preclinical and clinical studies;
- support of the registration process;
- commercial production of substances at Mirpharm sites (RF and EU);
- technology transfer to the customer’s site.
Contract manufacture services
- contract manufacture of substances in Russia and the EU;
- contract manufacture of finished drug products in Russia - solid forms (tablets, capsules);
- contract manufacture of finished drug products in Europe - liquid forms (solutions for injections, concentrates, lyophilisates, including peptide and oncological ones).