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Granules India’s arm gets USFDA’s nod for Trospium Chloride Extended-Release Capsules

24 Apr 2020 Evaluate
Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals Inc (GPI), has received approval for its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (US FDA) for Trospium Chloride Extended-Release Capsules, 60 mg. It is bioequivalent to the reference listed drug product (RLD), Sanctura XR Capsules, 60 mg, of Allergan, Inc.

Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

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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