Granules India’s arm gets USFDA’s nod for Potassium Chloride Extended-Release Tablets

05 Mar 2020 Evaluate

Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc. has received approval from US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended-Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg). It is bioequivalent to the reference listed drug product (RLD), Klor-Con Extended- Release Tablets, 8 mEq (600 mg) and 10 mEq (750 mg), of Upsher-Smith Laboratories, LLC.( Klor-Con is a trademark of Upsher-Smith Laboratories, LLC.) 

The Klor-Con brand and generic had U.S. sales of approximately $54 million MAT for the most recent twelve months ending in December 2019. The company now has a total of 24 ANDA approvals from USFDA (22 Final approvals and 2 tentative approvals).

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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