Ahmedabad, India, February 22, 2025 – Zydus Lifesciences Limited (NSE: ZYDUSLIFE, BSE: 532321) has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg. This approval marks another milestone in Zydus' growing portfolio of U.S.-approved formulations.
Key Highlights:
- Drug Indication:
- Used for relief of rheumatoid arthritis and osteoarthritis symptoms
- Helps reduce the risk of upper gastrointestinal ulcers in patients using ibuprofen for extended periods
- Reference Drug: Duexis Tablets (800 mg/26.6 mg)
- Manufacturing Location: Zydus Lifesciences Ltd (SEZ), Ahmedabad
- Market Data:
- The drug recorded annual sales of $3.6 million in the U.S. (IQVIA MAT December 2024)
- Regulatory Milestone:
- With this approval, Zydus now has 415 USFDA approvals
- The company has filed 483 ANDAs since FY 2003-04 (as of December 31, 2024)
