CDRI Production Company (ChemRar Group) has successfully confirmed its compliance with GMP standards
The Chemical Diversity Research Institute (CDRI LLC , part of the ChemRar Group, Khimki, Moscow Region) has successfully passed the inspection of the Ministry of Industry and Trade of the Russian Federation and received an updated GMP certificate, confirming the current license for the production of medicines for medical use.
During the inspection of the inspectorate, the full compliance of production processes and quality control systems of products with established industry standards was confirmed. The company strictly adheres to the requirements of the registration dossier, clinical trial protocols and technical specifications for its products. An integrated approach to product quality guarantees a high degree of patient health protection.
«Receiving the updated GMP certificate of the EAEU once again confirms the highest quality standards of production at our enterprise and indicates serious plans to expand the presence of our medicines on the market of Russia and the Eurasian Economic Union. Compliance with the EAEU GMP requirements guarantees the safety, effectiveness and quality of our products, and allows us to provide patients with modern and affordable medicines. GMP certification is not only a recognition of our work at the national level, but above all, the trust of patients, which we greatly value and do everything necessary and possible to justify it,» commented Natalia Papazova, CEO of CDRI LLC.
CDRI LLC is a full—cycle pharmaceutical company engaged in the development and production of innovative and reproduced medicines, including pharmaceutical substances. In its activities, the company is guided by the requirements of the national pharmacopoeia and the standards of the Russian Federation, the EAEU, the EMA, the FDA, as well as the recommendations of the ICH.
35 years of experience in the Russian and international markets, modern research infrastructure and regular internal and external audits allow CDRI LLC to provide a full range of services for the development, implementation and registration of active pharmaceutical substances and finished dosage forms (tablets, capsules, injection solutions) on a contractual basis. The company’s products are used in various therapeutic fields, including oncology, autoimmune, neurological, metabolic and infectious diseases.