The Ministry of Industry and Trade of the Russian Federation has added new data to the “Information on Issued, Withdrawn Certificates of Compliance of Manufacturers of Medicinal Products for Medical Use with the Requirements of Good Manufacturing Practice of the Eurasian Economic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 January 30 and February 5, 2026, the regulator issued 18 certificates to Russian and foreign manufacturers, while a decision to refuse issuance was made for one application.
Geography and Key Recipients
In early February, the registry was updated with entries for production sites from four countries: Russia, Serbia, Bulgaria, and Spain. [cite_start]A total of 18 sites received positive decisions[cite: 206].
Among Russian companies, major players such as Velpharm LLC (multiple decisions), NPF Materia Medica Holding LLC, and Kraspharma PJSC received confirmation of compliance. [cite_start]Certificates were also issued to medical gas producers (Praxair Samara LLC, Kubantechgaz CJSC, Promgazservis LLC) and the Samara Regional Clinical Blood Transfusion Station[cite: 206].
[cite_start]The international segment is represented by the Serbian site PharmaS d.o.o., the Bulgarian manufacturer Adipharm EAD, and the Spanish company Laboratorios Rubio S.A.[cite: 206].The full list of issued certificates is presented in the table below.
Issued GMP Certificates (30.01.2026 – 05.02.2026)
| Manufacturer | Country | Decision Date |
|---|---|---|
| Samara Regional Clinical Blood Transfusion Station (GBUZ SOKSPK) | Russia | 30.01.2026 |
| Kraspharma PJSC | Russia | 30.01.2026 |
| Kraspharma PJSC | Russia | 30.01.2026 |
| Praxair Samara LLC | Russia | 30.01.2026 |
| PharmaS d.o.o. Belgrade | Serbia | 30.01.2026 |
| Kubantechgaz CJSC | Russia | 30.01.2026 |
| Adipharm EAD | Bulgaria | 02.02.2026 |
| Kraspharma PJSC | Russia | 02.02.2026 |
| Promgazservis LLC | Russia | 03.02.2026 |
| Laboratorios Rubio S.A. | Spain | 03.02.2026 |
| Velpharm LLC | Russia | 04.02.2026 |
| Velpharm LLC | Russia | 04.02.2026 |
| Velpharm LLC | Russia | 04.02.2026 |
| NPF Materia Medica Holding LLC | Russia | 04.02.2026 |
| NPF Materia Medica Holding LLC | Russia | 04.02.2026 |
| NPF Materia Medica Holding LLC | Russia | 05.02.2026 |
| Velpharm LLC | Russia | 05.02.2026 |
| Velpharm LLC | Russia | 05.02.2026 |
Refusals of Certificates
[cite_start]During the same period, the Ministry of Industry and Trade made a decision to refuse the issuance of a certificate for one production site. The list includes the Russian manufacturer YuzhPharm LLC[cite: 207].| Enterprise | Country | Decision Date |
|---|---|---|
| YuzhPharm LLC | Russia | 02.02.2026 |
Previously on the topic:
First GMP certificates issued and refusals in 2026
GMP Registry: New Certificates Issued and Refusals in January 2026
GMP Registry: 19 new certificates and 3 refusals at the end of January
Source: Unified Register of Drug Manufacturers
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