Granules India foreign subsidiary gets USFDA approval; stock price gains

This product will be launched through Granules Consumer Health (GCH) division.

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$(“.linkSignUp”).click();
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Granules India share price gained in early trade on July 14 after USFDA approved the ANDA for Acetaminophen and Ibuprofen Tablets.

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of the company, for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC).

It is bioequivalent to the reference listed drug (RLD), Advil Dual Action with Acetaminophen Tablets, 250mg/125 mg (OTC), of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

This product will be launched through Granules Consumer Health (GCH) division.

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Acetaminophen and Ibuprofen Tablets are used for temporary relief of minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis.

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

The Advil Dual Action with Acetaminophen Tablets (OTC) brand and store brands had combined U.S. sales of approximately $70 million for the most recent twelve months based on IRI multi-outlet market data.

Advil is a registered trademark of GlaxoSmithKline Consumer Healthcare Holdings (US).

On July 13, USFDA issued an Establishment Inspection Report (EIR) for the Gagillapur facility of the Company located in Hyderabad, Telangana, India.

This facility, that manufactures finished dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs) was inspected by the US FDA as a part of a PAI in January 2023 which resulted in 3(three) observations during the inspection. The Company responded to these observations within the stipulated period.

At 09:40 hrs Granules India was quoting at Rs 302.95, up Rs 0.60, or 0.20 percent.