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.

Departments

  • 01

    Business Development

    In general, this department is responsible for the development of the company's product portfolio based on an analysis of market needs, incoming proposals and company’s technological capabilities. The staff of the department carry out a full cycle of development and production launch of company’s new products - from the synthesis of active molecules and the study of their pharmacological properties, to performance of full-fledged clinical studies and introduction of new finished dosage forms into manufacture

  • 02

    API Manufacture

    This department carries out complete synthesis of active pharmaceutical substances. The department’s technological capabilities allow the production of both synthetic substances in the amount of several tons per year and high-tech substances with an annual consumption of up to 100 grams per year

  • 03

    Manufacture of finished drug products

    This department is responsible for the production of finished drug products in the form of tablets and capsules. Capacities of the finished drug products production allow to manufacture up to 200 million tablets and up to 50 million capsules

  • 04

    Quality

    This department ensures the functioning of the quality assurance system in accordance with the requirements of Russian legislation for the production of drug products and GMP requirements. Quality department carries out proper quality control of drug products at all stages of production, carries out work on prevention and identification of inconsistencies at all stages of the manufacturing process

  • 05

    Technical

    This department provides technical support to the company’s production units in order to ensure uninterrupted production

  • 06

    Procurement and sales

    This department is responsible for supplying the production units with the necessary raw materials and materials of the required quality in a timely manner in order to ensure uninterrupted production of the company's products. In addition, this department is responsible for the sales of finished products

Green focus

  • 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

  • We control the tightness

    During the technological process, the equipment with hermetically sealed containers (is used)

  • 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

  • We clean the air

    The air from the equipment is cleaned before being discharged into the atmosphere

  • 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.

European part of the group:
  • 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).

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).

Please read our privacy policy

The present personal data processing policy is drawn up in accordance with the requirements of the Federal Law of July 27, 2006. No. 152-FЗ “On Personal Data” and determines the procedure for processing personal data and measures to ensure the security of personal data of Mir-Pharm LLC (hereinafter referred to as the Operator).

The operator sets as his most important goal and condition for the implementation of his activities the respect for the rights and freedoms of man and citizen in the processing of his personal data, including the protection of the rights to privacy, personal and family confidentiality.

The Operator's policy regarding the processing of personal data (hereinafter - the Policy) applies to all information that the Operator can receive about visitors of the website https://mirpharm.ru.

The user can get any clarification on issues of interest regarding the processing of his personal data by contacting the Operator via e-mail info@mirpharm.ru.

The current version of the Policy is located in free access on the Internet at https://mirpharm.ru/policy.

This document will reflect any changes in the policy of processing personal data by the Operator. The policy is valid indefinitely until it is replaced with a new version.