GMP Registry Update: New Certificates and Refusals in Mid-February 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The Ministry of Industry and Trade of the Russian Federation has added new data to the “Information on Issued, Withdrawn Certificates of Compliance of Manufacturers of Medicinal Products for Medical Use with the Requirements of Good Manufacturing Practice of the Eurasian Economic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 February 16 and 18, 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 second half of February, the registry was updated with entries for production sites from two countries: Russia and Spain. A total of 7 sites received positive decisions.

Among Russian companies, manufacturers such as PIQ-PHARMA CHEM LLC, In G LLC (multiple decisions), PHARMACOR PRODUCTION LLC (multiple decisions), and Immunotherapy Center “Immunohelp” LLC received confirmation of compliance.

The international segment in this update is represented by the Spanish company Towa Pharmaceutical Europe S.L..

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

Issued GMP Certificates (16.02.2026 – 18.02.2026)

Refusals of Certificates

The inspection procedure also revealed non-compliance with the established requirements. According to the updated registry of refusals, on February 18, 2026, the Ministry of Industry and Trade issued two decisions to refuse a GMP certificate.

Both decisions concern a single institution — the Federal State Budgetary Scientific Institution “All-Russian Scientific Research Institute of Medicinal and Aromatic Plants” (FGBNU VILAR), located in Russia. 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

As of February 20, 2026, 1585 unique production sites with a valid GMP certificate status are registered in the Register of Issued GMP Certificates.

Geographical Distribution

Production sites with a valid EAEU GMP certificate are represented by manufacturers from 62 different countries.

Earlier, the head of the core institute (FBU “GILS i NP” of the Ministry of Industry and Trade of the Russian Federation) Vladislav Shestakov stated that today there are about 700 manufacturers on the market who have not undergone GMP inspections once in the last 10 years.

Previously on the topic:
First Issued GMP Certificates and Refusals in 2026
GMP Registry: New Certificates Issued and Refusals in January 2026
Statistics on GMP Certificate Issuance and Refusal Analysis by Country for a Five-Year Period
GMP Registry: New Certificates Issued and Refusals in January 2026
GMP Registry Update: New Certificate Issuances and Refusals in Early February 2026
GMP Registry Update: New Certificate Issuances by February 13, 2026

Source: Unified Register of Drug Manufacturers