Vistin Pharma manufactures Metformin Direct Compressible:
- Metformin granulate DC grade 92.6% is with magnesium stearate (lubricant), and thus direct compressible material for intended for plain Metformin immediate release tablets.
Batch size
800 kg
COMPLIANCE
USP for the API
REGULATORY STATUS
- 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) and the Norwegian Medicines Agency
PACKING
25 kg net, packed in sealed double polyethylene bags in fiber drums/cartons
400 and 800kg Big Bag packaging on request.
SHELF-LIFE
2 years when stored in sealed double polyethylene bags in fiber drums/cartons
MANUFACTURING AND RELEASE
Kragerø, Norway
- Metformin DC 95% grade available on request.