Zydus Lifesciences Limited has recently informed exchanges that the company received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Ibuprofen and Famotidine tablets (800 mg/26.6 mg) in the U.S. This product is the generic version of Duexis® tablets and is used to relieve symptoms of rheumatoid arthritis and osteoarthritis while reducing the risk of upper gastrointestinal ulcers in patients taking ibuprofen.
The approved tablets will be manufactured at Zydus Lifesciences Ltd (SEZ), Ahmedabad. The combination of ibuprofen, a pain reliever, and famotidine, an acid-reducing agent, helps patients manage pain without increasing the risk of stomach ulcers.
According to IQVIA MAT data (December 2024), the Ibuprofen and Famotidine tablet market in the U.S. was valued at approximately USD 3.6 million annually.
With this approval, Zydus now has a total of 415 USFDA approvals and has filed 483 Abbreviated New Drug Applications (ANDAs) since FY 2003-04.
In the meantime, on February 14, the company successfully completed a routine USFDA surveillance inspection at its Topical Manufacturing facility in Changodar, Ahmedabad. The inspection, conducted from February 10 to 14, 2025, concluded with zero observations, highlighting the company’s unwavering commitment to quality, safety, and regulatory compliance.
