Glenmark Pharmaceuticals Receives FDA Approval for Acetaminophen and Ibuprofen Tablets

On April 29, 2024, Glenmark Pharmaceuticals informed the stock exchanges that the company had received final approval from the United States Food & Drug Administration (US FDA) for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC).

The company stated that the Food & Drug Administration determined these tablets to be bioequivalent to Advil®2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), of Haleon US Holdings, LLC. Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the United States by Glenmark Therapeutics Inc., USA.

According to Nielsen® syndicated data for the latest 52-week period ending March 23, 2024, the Advil® Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC) market achieved annual sales of approximately $84.1 million.

Currently, Glenmark Pharmaceuticals’ portfolio consists of 195 products authorised for distribution in the United States marketplace and 52 Abbreviated New Drug Application (ANDA) pending approval with the United States Food & Drug Administration. In addition to these internal filings, Glenmark Pharmaceuticals stated that the company continues to determine and research external development collaborations to increase and accelerate the growth of its existing pipeline and portfolio.

In January 2024, Glenmark Pharmaceuticals partnered with Ichnos Sciences Inc and formed Ichnos Glenmark Innovation, to accelerate new drug discovery in cancer treatment. The newly established Ichnos Glenmark Innovation boasts a strong pipeline comprising three innovative oncology molecules undergoing clinical trials, targeting multiple myeloma, acute myeloid leukaemia, and solid tumours. Two of these molecules have received orphan drug designation from the United States Food & Drug Administration. Moreover, Ichnos Glenmark Innovation possesses two autoimmune disease assets licensed to prominent companies.

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd is a research-led pharmaceutical company in the world. The company has a presence across branded, generics, and Over-the-Counter (OTC) segments, focusing on therapeutic areas such as dermatology, oncology and respiratory. The company has 11 world-class manufacturing facilities spread across 4 continents and operations in more than 80 countries. In Q3 FY 2024, Glenmark Pharmaceuticals Ltd reported a revenue of ₹1,365.10 crore, which is less by approximately 36.86% compared to Q3 FY 2023.

On April 29, 2024, the share price of Glenmark Pharmaceuticals Ltd opened at ₹1,090.00, touching the day’s high at ₹1,090.95, as of 9:36 AM on the NSE.

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