First Issued GMP Certificates and Refusals in 2026

January 2026 was marked by high regulatory activity: the Ministry of Industry and Trade (Minpromtorg) issued a number of Good Manufacturing Practice (GMP) compliance certificates to both foreign giants and domestic plants, though not without refusals.

Successful Inspections

Among the foreign manufacturers confirming their sites’ compliance with Russian requirements at the beginning of the year are production units of global corporations. In particular, certificates were received by the facilities of Takeda (Austria), Astellas (Ireland), and Sanofi (Genzyme site in Flanders).

The Russian segment also replenished its portfolio of permits. The manufacturer of radiopharmaceuticals RadioMedSyntez, the Sintez plant (Kurgan), and the pharmaceutical division of the metallurgical giant NLMK successfully passed inspections.

List of Issued GMP Certificates (January 2026)

Refusals to Issue

The regulator also issued a number of negative decisions. Difficulties in confirming compliance arose for two Russian enterprises. It is noteworthy that the Kurgan plant Sintez, which received a certificate on January 16, received refusals both the day before and on the same day (likely concerning other production lines or specific areas).

The list of refusals also includes FSUE SKTB Technolog.

List of Refusal Decisions (January 2026)

Source: Unified Register of Medicines Manufacturers