GMP Registry Update: New Certificate Issuances and Refusals in Early 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The Ministry of Industry and Trade of the Russian Federation has added new data to the “Information on Issued, Withdrawn Certificates of Compliance of Manufacturers of Medicinal Products for Medical Use with the Requirements of Good Manufacturing Practice of the Eurasian Economic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 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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