Blending of pharmaceutical excipients under certification EXCiPACT®, production in clean room class D (ISO 8 according to EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines).
The highest achievable class of purity prescribed for pharmaceutical excipients.
EXCiPACT® certificate scope: Manufacturing of pharmaceutical excipients by blending, mixing and packaging of mono-excipients in powder.
PRODUCTION TECHNOLOGY FOR BLENDING:
Volume: 1100 litres of new modern technology, made from stainless steel
600 kg blends per batch
Performance: 4 650 000 kg per year
Complemented by storage of excipients in GDP (Good Distribution Practice) certified warehouse, capacity up to 5.000 pallets locations, temperature-controlled + refrigerated rooms, service is provided in Stachovice HUB.