Granules India’s arm gets USFDA’s nod for Butalbital, Acetaminophen and Caffeine Capsules

09 Apr 2020 Evaluate
Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals has received approval for its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (US FDA) 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 has a total of 25 ANDA approvals from US FDA (23 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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