Chemical Diversity Research Institute
Development and production of drugs
Chemical Diversity Research Institute of the ChemRar Group is a pharmaceutical company, which includes an R&D division and its own production of pharmaceutical substances and drug products in solid dosage forms. The available resources and infrastructure allow us to offer our customers a full range of works on the development, production, and registration of drug products, both pharmaceutical substances and finished dosage forms.
In our work, we are guided by the requirements of the national pharmacopoeia and national standards of the Russian Federation, EAEU, EMA, FDA requirements, and ICH recommendations.
Development of active pharmaceutical ingredients (API):
- Development of a synthesis scheme and a technological process for the API production;
- Development of analytical methods for the control of the quality of intermediate and finished products, validation of analytical methods, and development of a quality specification;
- Certification of reference standards;
- Study of API stability in accordance with the ICH recommendations;
- Development of regulatory documents;
- Production of API batches for clinical trials.
Development of technologies for the production of finished dosage forms (FDF):
- Development of the FDF composition and production technology in accordance with the ICH recommendations;
- Development of analytical methods for the control of the quality of drug product, validation of analytical methods, and development of a quality specification;
- Study of FDF stability in accordance with the ICH recommendations;
- Development of regulatory documents;
- Production of FDF batches for non-clinical and clinical trials.
Production of drug products:
- Transfer of the technological process and analytical methods to the client’s production site;
- Development of transfer documentation;
- Contract manufacturing of pharmaceutical substances and drug products.
Regulatory services:
- Development of a drug product dossier in the e-CTD format for the EAEU, EP, FDA markets, etc.
- Registration of drug products in the Russian Federation and the EAEU.
Chemical Diversity Research Institute is now producing 15 drug products. Besides, CDRI has about 20 products in the portfolio that are at various development stages. CDRI carries out the full production cycle of registered innovative and generic drug products used in various therapeutic areas: oncology, autoimmune, neurological, metabolic, viral diseases.