Granules India arm bags USFDA nod for Acetaminophen and Ibuprofen Tablets

Written by Ruchika Sharma Published On 2023-07-14T11:09:29+05:30 | Updated On 14 July 2023 11:09 AM IST

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

Hyderabad: 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.

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

Medical Dialogues team had earlier reported that Marksans Pharma Ltd., a provider of consumer self-care products had also received final approval from the USFDA for its ANDA for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg, OTC bioequivalent of Advil Dual Action Tablets 250 mg/125 mg.

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).

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered at Hyderabad. The company is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, U.S. and U.K. The Company has 8 manufacturing facilities out of which 6 are located in India and 2 are in 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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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751