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Metformin HCl

Vistin Pharma is a leading European producer and supplier of high quality Metformin HCl, an active pharmaceutical ingredient in first-line treatment of diabetes II, and commands around 10 percent of the global Metformin HCl market. Vistin Pharma produces Metformin HCl at a dedicated modern plant in Kragerø, Norway: the world’s largest production line for Metformin HCl with batch sizes of 3000 kg. Our Metformin HCl is synthesised and processed to supply the market with the purest and best free-flowing quality.

COMPLIANCE

Ph.Eur., BP, JP and USP

REGULATORY STATUS

  • Certificate of Suitability to the European Pharmacopoeia (CEP), European DMF, and 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), Brazillian Health Authorities (ANVISA ), Korean Health Authorities (KFDA) and the Norwegian Medicines Agency.

PACKING

25 kg net, packed in sealed double polyethylene bags in cardboard carton.

RE-TEST PERIOD

5 years when stored in sealed double polyethylene bags in cardboard carton.

MANUFACTURING AND RELEASE

Kragerø, Norway

 

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Tips en venn

Vistin Pharma AS
Østensjøveien 27
P.O. Box 6735 Etterstad
NO-0609 Oslo, Norway
Tel: +47 35 98 42 00
E-mail: vistin@vistin.com
VAT No: NO813120232MVA