Drugs Medical Pharma

Granules India gets FDA nod for bio equivalent of Advil


HQ Team

July 15, 2023: Granules India Limited, an Indian vertically integrated, high-growth pharmaceutical product manufacturing company, has got the US Food & Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for acetaminophen and ibuprofen tablets, 250 mg/125 mg (OTC). These are bioequivalents of the reference listed drug (RLD), Advil Dual Action with acetaminophen tablets, 250mg/125 mg (OTC), of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company, filed the application. This product will be launched through the Granules Consumer Health (GCH) division.

Acetaminophen and ibuprofen tablets are used for temporary relief of minor aches and pains due to headaches, toothaches, backaches, menstrual cramps, muscular aches, and minor arthritis pain.

Granules has a total of 59 ANDA approvals from the US FDA (57 Final and 2 tentative approvals).

The USFDA, in January, issued an Establishment Inspection Report (EIR) for the Gagillapur facility of Granular located in Hyderabad, Telangana, India. This facility manufactures finished dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs).

According to IRI multi-outlet market data, the Advil Dual Action with acetaminophen tablets (OTC) brand and store brands had combined US sales of approximately $70 million last year.

Advil is a registered trademark of GlaxoSmithKline Consumer Healthcare Holdings (US). Granules products are distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US and UK.





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