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Granules India receives USFDA approval for Metformin ER Tablets

20 Mar 2018 Evaluate

Granules India has received approval from the US Food & Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Metformin Extended Release (ER) Tablets 500 mg and 750 mg. The approved ANDA is the bioequivalent to the reference listed drug product (RLD), Glucophage XR tablets of Bristol Myers Squibb. The company intends to commercialize this product shortly.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).



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