Zydus Lifesciences Gets USFDA Nod For Celecoxib Capsules, Expands Pain Management Portfolio

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Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) to market Celecoxib Capsules in the US, strengthening its presence in the anti-inflammatory and pain relief segment. The drug is a generic version of Celebrex, widely used for treating arthritis and acute pain.

Key Highlights From The Approval

- Celecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) indicated for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and menstrual pain
- The approved strengths include 50 mg, 100 mg, 200 mg, and 400 mg capsules
- Zydus will manufacture the drug at its formulation facility in Ahmedabad SEZ, India
- The approval adds to Zydus’s growing US generics portfolio, which now includes over 392 final approvals and 460 ANDA filings since FY 2003–04

Market And Strategic Impact

- Celecoxib had annual US sales of over USD 300 million, according to IQVIA data
- The approval enhances Zydus’s competitiveness in the chronic pain and inflammation segment, especially amid rising demand for affordable alternatives
- The company continues to focus on expanding its specialty and generics pipeline in regulated markets

Outlook

Zydus’s latest approval reflects its consistent regulatory momentum and strategic focus on high-volume therapeutic areas. The launch is expected to contribute meaningfully to its US revenue in FY26.

Sources: Business Standard, Economic Times, Zydus Lifesciences Corporate Filings, USFDA Database, Moneycontrol.