Glenmark Pharmaceuticals Ltd. has received final approval from the United States Food & Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets, 250 mg/125 mg (OTC).
The tablets were determined by the FDA to be bioequivalent1 to Advil®2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), of Haleon US Holdings, LLC.
Glenmark’s tablets will be distributed in the US by Glenmark Therapeutics Inc., USA.
Glenmark’s current portfolio consists of 195 products authorised for distribution in the US and 52 ANDA’s pending approval with the USFDA. In addition to these internal filings, the company has been exploring external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
The stock traded at ₹1,086.45 on the NSE, up 0.66 per cent as of 9.32 am.