EAEU GMP Certificate issued to Pharmasyntez

EAEU GMP Certificate issued to Pharmasyntez

The Pharmasyntez Group of Companies is granted Certificate GMP/EAEU/RU/00016-2021 certifying compliance of the pharmaceutical product manufacturer to the requirements of Good Manufacturing Practice of the Eurasian Economic Union.

GMP certification is an important procedure for any pharmaceutical company. It provides great advantages such as:

  • the potential to introduce its products to the international market
  • the potential to attract investors to implement expansion projects
  • participation in the competitive selection of suppliers, including for public procurement.

The main purpose of the GMP certification process in international practice is to verify the proper functioning of the manufacturer’s pharmaceutical quality system. This, in turn, ensures that drug products meet the safety and efficacy criteria laid down at the stage of their development and tested in clinical trials. Certified facilities manufacture drug products under conditions that allow minimizing risks to patients associated with the product safety and quality.

It should noted that employees of BratskChemSyntez received training in the EAEU GMP requirements late last year.

The Pharmasyntez Group of Companies also was one of the first in Russia to be granted a Marketing Authorization under the EAEU rules. Nomides (INN Oseltamivir), an antiviral drug, was licensed under the new procedure.

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