GMP Registry: 19 New Certificates and 3 Refusals at the End of January

The Ministry of Industry and Trade of the Russian Federation has entered new data into the “Information on issued, withdrawn certificates of compliance of manufacturers of medicinal products for human use with the Rules of Good Manufacturing Practice of the Eurasian Economic Union and certificates whose validity has been suspended or terminated.” In the period from January 23 to January 30, 2026, the regulator issued 19 certificates to Russian and foreign manufacturers, while decisions to refuse issuance were made for three applications.

Geography and Key Recipients

At the end of January, the registry was replenished with entries for production sites from seven countries: Russia, the USA, Italy, India, Argentina, China, and Bosnia and Herzegovina. A total of 19 sites received positive decisions.

Among domestic companies, compliance was confirmed by major players such as Ozon LLC, NPO Petrovax Pharm, ZAO Zelenaya Dubrava (several sites or production lines), as well as PJSC Kraspharma and others.

The foreign segment is represented, in particular, by the US plants of the contract manufacturer Catalent Pharma Solutions, the Italian site of Haupt Pharma Latina, and the Chinese biotechnology company Changchun BCHT Biotechnology.

The full list of issued certificates is presented in the table below.

Issued GMP Certificates (January 23, 2026 – January 30, 2026)

Refusals to Issue Certificates

During the same period, the Ministry of Industry and Trade made decisions to refuse the issuance of certificates for three production sites. The list includes the Spanish company Bioiberica S.A.U., the Argentine TRB Pharma S.A., and the Russian JSC Altaystroydetal.

Previously on the topic:
First Issued GMP Certificates and Refusals in 2026
GMP Registry: New Certificates Issued and Refusals in January 2026

Source: Unified Register of Drug Manufacturers