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Granules India rose 1.57% to Rs 326.90 after the company said that US drug regulator has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).The product is bioequivalent to the reference listed drug product (RLD), Excedrin migraine tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The drug is indicated for treating migraine. The product will be manufactured at the company s Hyderabad facility and is expected to be launched shortly. Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc., commenting on the approval, said: We are pleased to announce approval of acetaminophen, aspirin and caffeine tablets, emphasizing our focus on building sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months from filing. With this, we have received three ANDA approvals over the past month.

Andhra pradeshUnited kingdomPriyanka chigurupatiGranules pharmaceuticals incGranules indiaAbbreviated new drug applicationCaffeine tabletsGlaxosmithkline consumerExecutive directorGranules pharmaceuticalsCapital marketMg carsExcedrin migraineHyderabad facilityPharmaceutical formulation intermediatesTriple combination