Shares of Granules India Ltd. gained on Friday after the company said that its foreign arm has received approval from the US Food and Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets, which are used for treating minor pain and aches.
According to a filing to the stock exchanges, the company's arm Granules Pharmaceuticals Inc obtained the clearance for over-the-counter (OTC) medications Acetaminophen and Ibuprofen Tablets in the strength of 250 mg and 125 mg.
The product is bioequivalent to the reference listed drug, Advil Dual Action, with Acetaminophen Tablets, 250mg/125 mg of US-based GlaxoSmithKline Consumer Healthcare Holdings LLC.
Acetaminophen and Ibuprofen tablets are used for temporary relief of minor aches and pains due to headaches, toothache, backaches, menstrual cramps, muscular aches, and minor pain of arthritis.
The company said that the product will be launched through Granules Consumer Health (GCH) division.
The Advil Dual Action with acetaminophen tablets (OTC) brand and store brands had combined sales of USD 70 million in the US for the most recent 12 months based on IRI multi-outlet market data.
With the latest authorisation, Granules now have a total of 59 ANDA approvals from the USFDA comprising 57 final clearances and 2 tentative nods.
On Thursday, Granules received an Establishment Inspection Report (EIR) from the USFDA for its Gagillapur facility located in Hyderabad, Telangana. This facility is used for manufacturing finished dosages and Pharmaceutical Formulation Intermediates (PFIs).
Shares of Granules India were trading 0.55 percent higher at Rs 304 apiece on BSE at 10:01 AM.
