Zydus Lifesciences Limited has secured final approval from the United States Food and Drug Administration (USFDA) for Celecoxib Capsules in four strengths: 50 mg, 100 mg, 200 mg, and 400 mg. The generic version references Celebrex Capsules and represents a significant addition to the company's growing portfolio of FDA-approved medications.
Market Opportunity and Manufacturing
The approved Celecoxib capsules will be manufactured at Zydus Lifesciences Ltd (SEZ) in Ahmedabad. According to IQVIA MAT data from May 2025, Celecoxib Capsules recorded annual sales of approximately USD 122.6 million in the U.S. market, indicating substantial commercial potential for the generic version.
Therapeutic Applications
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing hormones that cause inflammation and pain in the body. The medication is indicated for treating pain or inflammation caused by multiple conditions including arthritis, ankylosing spondylitis, and menstrual pain. Additionally, it is approved for treating juvenile rheumatoid arthritis in children who are at least 2 years old.
Regulatory Milestone
This approval marks another significant regulatory achievement for Zydus Lifesciences. The company now holds 428 final approvals and has filed 492 Abbreviated New Drug Applications (ANDAs) since beginning its U.S. regulatory filing process in FY 2003-04.
Earlier this year in February, the company also received USFDA approval to manufacture Ibuprofen and Famotidine tablets, 800 mg/26.6 mg, as a generic version of Duexis Tablets. This combination medication is indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis while decreasing the risk of developing upper gastrointestinal ulcers in patients taking ibuprofen for those indications.
Company Profile
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The organization employs 27,000 people worldwide, including 1,400 scientists engaged in research and development. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
The company's consolidated net profit decreased 0.96% to Rs 1,170.9 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 compared to Q4 FY24.
