GMP Registry Update: 7 New Certificates and 2 Refusals in Late April 2026

The Ministry of Industry and Trade of the Russian Federation has added new data to the “Information on Issued, Withdrawn Certificates of Compliance of Manufacturers of Medicinal Products for Medical Use with the Requirements of Good Manufacturing Practice of the Eurasian Economic Union and Certificates Suspended or Terminated.” Between April 20 and 22, 2026, the regulator issued 7 certificates to Russian and foreign manufacturers, while decisions to refuse issuance were made for two applications.

Geography and Key Recipients

In the beginning of the third decade of April, the registry was updated with entries for production sites from two countries: Russia and Morocco. A total of 7 sites received positive decisions.

Among Russian companies, manufacturers such as Tula Pharmaceutical Factory LLC (TFF LLC) (three decisions), Rapharma JSC, AFS-technologies LLC, and Genentech Inc. received confirmation of compliance.

The international segment in this update is represented by a manufacturer from Morocco — Pharmaceutical Laboratory GALENICA JSC.

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

Issued GMP Certificates (20.04.2026 – 22.04.2026)

Refusals of Certificates

The inspection procedure also revealed non-compliance with the established requirements. According to the updated registry, on April 21, 2026, the Ministry of Industry and Trade issued two decisions to refuse a GMP certificate.

Both refusals were received by the Russian enterprise Advanced Perm LLC. The reasons for refusal are traditionally not disclosed in the public part of the registry, however, they are usually associated with critical or major violations of production processes identified during the audit.

Production Sites with a Valid EAEU GMP Certificate

According to current data, as of April 22, 2026:

• The total number of GMP certificates with a “Valid” status is 1677;
• The number of sites with a valid GMP certificate (unique address) is 1634;
• The number of companies holding a valid GMP certificate (unique name) is 1083.

Geographical Distribution

Production sites with a valid EAEU GMP certificate are represented by manufacturers from dozens of different countries. Almost half of them are located in Russia.

Source: Unified Register of Drug Manufacturers