Binnopharm Group Boosts Its Export Potential: 49 New Marketing Authorisations in 2025
In 2025, Binnopharm Group strengthened its product portfolio and geographical presence by obtaining 49 new marketing authorisations (MA) for medicines and dietary supplements. Two-thirds of new registrations were in CIS countries, where 32 national authorisations were obtained. Another 17 MAs were successfully obtained in the markets of the Eurasian Economic Union (EAEU) member states. The procedures were conducted in full compliance with EAEU regulatory requirements and the national legislation of 11 countries, covering both prescription and over-the-counter drugs in various therapeutic areas.
At the same time, the company is actively engaged in the expansion of its presence in Southeast Asia. Thus, at the end of 2025, an application for registration of a gastroenterological drug was submitted in Vietnam. Following this, registration procedures are scheduled to begin in Indonesia.
Gulnara Setdekova, Director of Research and Regulatory Binnopharm Group: «In 2026, Binnopharm Group plans to continue its active registration work, focusing both on launching new products in countries where it already has a presence and on obtaining its first authorisations in key markets of Southeast Asia. This is in line with the company's long-term strategy to increase exports».
In addition to registering new drugs, over the past year Binnopharm Group has ensured the validity of more than 300 previously issued marketing authorisations in terms of compliance of drugs, excipients, and packaging materials quality with modern requirements, as well as extension of their validity periods, adding new substance manufacturers, updating instructions and package inserts. This work ensured continuity of production and supplies, and reduced the risks associated with change in the regulatory requirements.
