30-04-2025
Strides Pharma receives USFDA approval for Celecoxib Capsules
By Aman Shukla Published on April 30, 2025, 15:09 IST
Strides Pharma Science Limited announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, based in Singapore, has received approval from the United States Food & Drug Administration (USFDA) for Celecoxib Capsules in 100 mg, 200 mg, and 400 mg strengths.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Celebrex® (Celecoxib) Capsules, manufactured by Upjohn US 2 LLC. This approval allows Strides to expand its offerings in the anti-inflammatory therapeutic area.
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) and a selective COX-2 inhibitor. It is used in the treatment of various conditions including osteoarthritis, rheumatoid arthritis, acute pain, and primary dysmenorrhea.
According to data from IQVIA (IMS), the combined U.S. market size for Celecoxib Capsules across all approved strengths is approximately USD 116 million.
Strides will manufacture the approved Celecoxib Capsules at its facility located in Puducherry, India.
This development adds to Strides Pharma's generic product portfolio for the U.S. market and supports its strategy of providing cost-effective treatment options in the anti-inflammatory segment.
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
