Granules India gets USFDA approval for Butalbital, Acetaminophen, Caffeine Capsules

Hyderabad: Granules India Limited has announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly-owned foreign subsidiary of Granules India Limited for Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg.

It is bioequivalent to the reference listed drug product (RLD), Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg, of Nexgen Pharma, Inc.

Butalbital, Acetaminophen and Caffeine Capsules are used for the relief of the symptom complex of tension (or muscle contraction) headache.

Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg had U.S. sales of approximately $42 million MAT for the most recent twelve months ending in February 2020 according to IQVIA Health.

Granules now have a total of 25 ANDA approvals from US FDA (23 Final approvals and 2 tentative approvals).

Granules India is a growing pharmaceutical manufacturing company committed to operational excellence, quality and customer service. The Company produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice.

Granules support customers with a unique value, extensive product range, and proactive solutions. The Company's global presence extends to over 250 customers in 60 countries through offices in India, the U.S., and the U.K.

The Company has 6 manufacturing facilities out of which 5 are located in India and 1 in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.

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