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Metformin HCl

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

 

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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

 

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