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.
Source: amed.md