Glenmark Pharma gains on USFDA nod for minor pain relief tablets
Summary
The Acetaminophen and Ibuprofen tablets are used to relieve minor pains. These tablets are used to treat headache, backache, toothache, menstrual cramps, muscle aches or arthritis pain.
Glenmark Pharmaceuticals Ltd shares gained in morning trade on Monday after the company announced receiving final approval from the United States Food and Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets.
These tablets in the strength of 250 mg/125 mg have been deemed bioequivalent to Advil dual action with acetaminophen tablets, 250 mg/125 mg (OTC), distributed by Haleon US Holdings, LLC, Glenmark Pharmaceuticals said in a filing to the stock exchanges.
The Acetaminophen and Ibuprofen tablets are used to relieve minor pains. These tablets are used to treat headaches, backaches, toothaches, menstrual cramps, muscle aches or arthritis pain.
The new drug will be distributed in the US market by Glenmark Therapeutics Inc, USA, Glenmark Pharmaceuticals informed the stock exchanges.
Nielsen syndicated data for the latest 52-week period ending March 23, 2024, indicates that the Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC) market achieved approximately USD 84.1 million in annual sales.
Following the announcement, shares of Glenmark Pharma gained more than 1% in morning trade on Monday to an intraday high of ₹1,092.6 apiece. The pharma stock, however, pared early gains to trade at ₹1,084.6 apiece, up 0.42%, on the BSE around 11:50 am.
Glenmark currently has a portfolio of 195 products authorized for distribution in the US market, with 52 ANDAs awaiting FDA approval.
Alongside its internal filings, Glenmark is actively pursuing external development partnerships to complement and expedite the expansion of its pipeline and portfolio.
In January, Glenmark Pharmaceuticals announced that its subsidiary inked a licensing agreement to distribute cancer medications in India and other territories.
Glenmark Specialty SA entered into a licensing agreement with Jiangsu Alphamab Biopharmaceuticals and 3D Medicines for KN035 Envafolimab, a cancer treatment, in India and various other regions.
The additional territories encompass the Asia Pacific, Middle East, Africa, Russia, CIS, and Latin America, as stated by the company.
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