FSUE Endopharm (Moscow Endocrine Plant), subordinate to the Ministry of Industry and Trade of Russia, has launched production of domestic generics of all psychotropic drugs that were previously imported for Russian patients, including those for children suffering from convulsive syndrome of various etiology. The developed series of Clobazam in tablets (the first domestic analogue of the French Frisium), 7000 packages, has received quality compliance confirmation from Roszdravnadzor (Federal Service for Surveillance in Healthcare) and has already been put into civil circulation. FSUE Endopharm received a registration certificate for Clobazam in November last year.
“The organization of own production of such a drug is an important stage not only for Endopharm, but also in ensuring pharmaceutical safety throughout Russia. I would like to note that the company also makes an active contribution to ensuring technological sovereignty in other segments, in particular, it develops and creates local production of pharmaceutical substances (including for vital medicines), develops reference samples necessary for the production and quality control of drugs, has built from scratch the main technological facilities for opium poppy plant cultivation for painkillers manufacturing,” said Denis Manturov, Deputy Prime Minister of the Russian Federation and the country’s Minister of Industry and Trade.
To date, 100% of the needs of the country’s healthcare system in psychotropic drugs with INNs midazolam, diazepam and clobazam, which were previously imported, are satisfied with the products of FSUE Endopharm.
The next step will be the organization of a full-cycle production of these medicines. The company is currently studying the stability of midazolam, its own active pharmaceutical substance, and the production site for its manufacturing is scheduled to be commissioned for operation in the late 2023.