The Ministry of Industry and Trade of the Russian Federation issued certificates of compliance with the regulations of good manufacturing practice of the Eurasian Economic Union to FSUE “Moscow Endocrine Plant” (“Endopharm”).
During the inspection conducted, the authorized regulatory body of the Russian Federation comprehensively assessed the organization and equipment of production, the processes for ensuring and controlling the quality of medicines produced at the production sites of Endopharm.
Information about the certificates of each EAEU GMP production site issued to Endopharm is published in the state register on the website of the Ministry of Industry and Trade of Russia.
The inspected sites produce more than 100 types of drugs used in various fields of medicine: anesthesiology, ophthalmology, cardiology, psychiatry, gynecology, neurology, gastroenterology, most of which are included in the list of vital and essential drugs, including a portfolio of centrally acting analgesics in a wide range of dosage forms.
Compliance with GMP reguations has been confirmed, among other items, for the production of various types of active pharmaceutical ingredients from raw materials of animal origin, plant origin, obtained by biotechnological and chemical synthesis methods.
The pharmaceutical quality system of Endopharm ensures compliance with international and local regulatory legal acts and guarantees the safety, quality and effectiveness of products released.
FSUE “Moscow Endocrine Plant” (“Endopharm”) Confirmed Compliance with the EAEU GMP Standard
13 April 2022
Comment type is not specified in the component properties.