The Medicines Agency of the Republic of Moldova has issued the GMP Certificate for Balkan Pharmaceuticals


On 26.06.2017, the Medicines and Medical Devices Agency of the Republic of Moldova released the GMP Certificate for the Balkan Pharmaceuticals factory. The Certificate is issued for manufacturing sterile products (aseptic preparations - low volume liquids and injectable suspensions, sterilized products), non-sterile products (capsules, tablets, powders for solutions / suspensions for oral use) as well as for tests of quality control.

GMP Certificate No. AMDM/MD/GMP/001/2017 is the second certificate issued to Balkan Pharmaceuticals, since the Ministry of Health Order no. 309 of 26.03.2013 made the Good Manufacturing Practice (GMP) rules mandatory.

GMP regulations require a quality-based approach to manufacturing. Only 6 producers in the Republic of Moldova have a GMP Certificate.