Granules India arm bags USFDA nod for Acetaminophen and Ibuprofen Tablets

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.

Published On 2023-07-14 05:39 GMT | Update On 2023-07-14 05:39 GMT

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.

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

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

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Granules India arm bags USFDA nod for Acetaminophen and Ibuprofen Tablets

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.

Similar News

Police Have No Jurisdiction to Register FIR Under Drugs & Cosmetics Act: Delhi HC

MSD Pharma gets CDSCO panel nod for New Indications of Pembrolizumab in India

Cough Syrup Row: Rajasthan Practitioners Shift to Levocloperastine, Ambroxol Amid Dextromethorphan Concerns

Dummy Pharma Firms Under Probe for Rs 71 Crore Drug Scam in UP

Trump Warns Pharma Firms of 5-8% Extra Tariffs Ahead of October Drug Pricing Deadline

CDSCO Panel Directs Malik Lifesciences to Revise Phase III Trial Protocol for Tamsulosin, Dutasteride, Tadalafil FDC

Zydus Lifesciences Dr Sharvil Patel takes over as IPA President

Bangalore-based Indegene acquires BioPharm from Omnicom Health Group