Zydus Life receives USFDA approval for manufacturing Ibuprofen and Famotidine tablets

Zydus Lifesciences said that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Ibuprofen and Famotidine tablets, 800 mg/26.6 mg. (USRLD: Duexis Tablets, 800 mg/26.6 mg).

The combination of ibuprofen and famotidine is indicated for relieving the signs and symptoms of rheumatoid arthritis and osteoarthritis and for reducing the risk of developing upper gastrointestinal ulcers (gastric and/or duodenal ulcers) in patients using ibuprofen for these conditions. The tablets will be produced at Zydus Lifesciences' facility in SEZ, Ahmedabad.

Ibuprofen and Famotidine tablets generated annual sales of $3.6 million in the United States, according to IQVIA MAT December 2024. Since FY 2003-04, the company has filed 483 ANDAs and received 415 approvals.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter.

The scrip rose 0.79% to Rs 892.10 on the BSE.

Powered by Capital Market - Live News