FSUE “Endopharm” received the report on the conformity of the manufacturer of medicinal products for veterinary use to the requirements of the rules of Good Manufacturing Practice of the Eurasian Economic Union No. GMP-76/22.
EEU GMP rules for the production of veterinary medicinal products are the same as for the production of medicinal products for human use and additionally include special requirements for certain groups of veterinary medicinal products and immunobiological veterinary medicinal products.
The organization and equipping of production, the processes for ensuring and controlling the quality of veterinary medicinal products manufactured by the Enterprise were comprehensively assessed during the inspection conducted by the authorized regulatory body of the Russian Federation.
Medicines for animals is a new promising and demanded area of work for FSUE “Endopharm”, the purpose of which is to ensure the availability of necessary veterinary medicines in Russia. This year, the Enterprise released the first medicine for veterinary use – an analgesic with a combined mechanism of action. Until the end of the year, it is planned to release an injectable dosage form for non-inhalation general anesthesia.
The report on conformity to the EEU GMP requirements for the production of veterinary medicinal products increases the export potential of the Enterprise due to the possibility of bringing popular medicinal products for veterinary use to a single market of the EEU.
The production facilities of FSUE “Endopharm” also allow producing veterinary medicinal products in a wide range of dosage forms under contract manufacturing. The presence of an accredited testing laboratory, the scope of accreditation of which includes quality control of veterinary medicines, is an additional advantage of the Enterprise.
Reference:
GMP is the Good Manufacturing Practice rules that establish requirements for the organization of manufacture and quality control of medicines for medical and veterinary use.
Certificates of conformity of the manufacturer of medicinal products for medical use to the EEU GMP rules were issued to FSUE “Endopharm” by the Ministry of Industry and Trade of the Russian Federation in 2021. Compliance with GMP rules has been established, among other things, for the production of various types of active pharmaceutical ingredients from raw materials of animal origin, plant origin, those obtained by biotechnological and chemical synthesis methods.
Comment type is not specified in the component properties.