Natalya Papazova, Director General, CDRI LLC
Chemical Diversity Research Institute of the ChemRar Group is a full-cycle pharmaceutical company developing and manufactures innovative and reproduced medicinal products, including pharmaceutical substances, in compliance with all the requirements and rules of good international practice. In its work, the IIHR team is guided by the requirements of the national pharmacopoeia and national standards of the Russian Federation, the requirements of the EAEU, EMA, FDA and ICH recommendations.
More than 30 years of experience in the international drug development market and the availability of a state-of-the-art research infrastructure allow CDRI to perform a full range of services for the development, introduction into production, as well as registration of APIs and finished dosage forms, both solid (tablets, capsules) and solutions for injection, on a contract basis. CDRI research units regularly undergo internal inspections and audits of foreign and Russian pharmaceutical companies.
Registered innovative and generic medicines, the full production cycle of which is carried out by CDRI LLC, are used in various therapeutic areas: oncology, autoimmune, neurological, metabolic, and infectious diseases. The production facility of IIHR LLC is designed and built-in accordance with the rules of good manufacturing practice, has a license of the Ministry of Industry and Trade of the Russian Federation for the production of medicines and a GMP certificate of the EAEU.
All medicines are registered by the Ministry of Health of the Russian Federation and are approved for use in Russia.
CDRI LLC has implemented, operates and constantly improves a pharmaceutical quality system. The main objective of managing the pharmaceutical quality system is to ensure that all medicines produced by our company meet the established standards of good manufacturing practice.
The company has developed a comprehensive approach to product quality assurance, which plays an important role in protecting patient health.
Production sites of CDRI LLC have licenses for the production of medicines (pharmaceutical substances and finished medicines), as well as certificates of compliance with the requirements of the Rules of Good Manufacturing Practice approved by the Decision of the Council of the Eurasian Economic Commission of 03.11.2016 N 77 "On Approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union".
