GMP Registry Update: 19 New Certificates and One Refusal in Mid-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The Ministry of Industry and Trade of the Russian Federation has added new data to the “Information on Issued, Withdrawn Certificates of Compliance of Manufacturers of Medicinal Products for Medical Use with the Requirements of Good Manufacturing Practice of the Eurasian Economic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 11 and 17, 2026, the regulator issued 19 certificates to Russian and foreign manufacturers, while a decision to refuse issuance was made for one application.

Geography and Key Recipients

In mid-April, the registry was updated with entries for production sites from five countries and one dependent territory: Russia, Italy, Austria, Japan, and Puerto Rico. A total of 19 sites received positive decisions.

Among Russian companies, manufacturers such as GEDEON RICHTER-RUS JSC (six decisions at once), N.N. Blokhin National Medical Research Center of Oncology (three decisions), Pharmstandard-Leksredstva OJSC, BioJet LLC, ISIDA LLC, Provider LLC, and CUKBG LLC received confirmation of compliance.

The international segment in this update is represented by manufacturers from Italy (Farmaceutici Formenti S.p.A. and Delpharm Milano S.R.L.), Austria (Globopharm Pharmazeutische Produktions- und Handelsgesellschaft mbH), Japan (Sumitomo Pharma Co., Ltd.), and Puerto Rico (Neolpharma, Inc.).

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

Issued GMP Certificates (11.04.2026 – 17.04.2026)

Refusals of Certificates

The inspection procedure also revealed non-compliance with the established requirements. According to the updated registry, on April 14, 2026, the Ministry of Industry and Trade issued one decision to refuse a GMP certificate.

The refusal was received by the French manufacturer Pharmaster +. 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 17, 2026:

• The total number of GMP certificates with a “Valid” status is 1678;
• The number of sites with a valid GMP certificate (unique address) is 1633;
• The number of companies holding a valid GMP certificate (unique name) is 1087.

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