Our Metformin HCl is synthesised and processed to supply the market with the purest and best free-flowing quality. Vistin Pharma API has no detectable levels of Nitrosamines, and very low levels of residual DMA (Impurity F)
BATCH SIZE
3100 kg
COMPLIANCE
Ph.Eur., BP, JP and USP
REGULATORY STATUS
- Certificate of Suitability to the European Pharmacopoeia (CEP) and European DMF
- Letter of Authorisation to the US DMF available on request
- Manufactured according to current Good Manufacturing Practice (cGMP)
- Inspected by the US Food and Drug Administration (FDA), Brazilian Health Authorities (ANVISA ), Korean Health Authorities (KFDA), Japanese Health Authority (PMDA) and the Norwegian Medicines Agency
PACKING
25 kg net, packed in sealed double polyethylene bags in cardboard carton
400 and 800kg Big Bag packaging available on request
RE-TEST PERIOD
5 years when stored in sealed double polyethylene bags in cardboard carton
MANUFACTURING AND RELEASE
Kragerø, Norway