Zydus gains USFDA approval for ibuprofen/famotidine tablets

Zydus Lifesciences (BSE: ZYDUSLIFE) announced it has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg. The tablets are indicated for relief of rheumatoid arthritis and osteoarthritis symptoms and reducing the risk of gastrointestinal ulcers in patients taking ibuprofen. Zydus will produce the tablets at its Zydus Lifesciences Ltd (SEZ) facility in Ahmedabad. The annual sales for Ibuprofen and Famotidine tablets stood at $3.6 million in the United States as of December 2024. As of December 31, 2024, Zydus has secured 415 approvals and filed 483 ANDAs since FY2003-04.