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Metformin DC

Vistin Pharma manufactures two different grades of 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

20 kg net, packed in sealed double polyethylene bags in fiber drums/cartons

SHELF-LIFE

2 years when stored in sealed double polyethylene bags in fiber drums/cartons

MANUFACTURING AND RELEASE

Kragerø, Norway

-   In addition to Metformin granulate DC grade 92.6% Vistin Pharma can manufacture Metformin granulate DC 93.4%, which is without magnesium stearate and intended for use in combination products where our granulate is mixed with another API/granulate prior to compression

 

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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