Latest news with #Strides
The Hindu
30-04-2025
- Business
- The Hindu
Strides Pharma Science gets USFDA approval for Celecoxib capsules
Bengaluru-based Strides Pharma Science Limited (Strides) on Wednesday said that its step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Celecoxib Capsules, 100 mg, 200 mg, and 400 mg, from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Celebrex Capsules, 100 mg, 200 mg, and 400 mg, of Upjohn US 2 LLC, and would be manufactured at the company's facility in Puducherry, according to a company statement. The approval of Celecoxib Capsules would strengthen Strides' portfolio in the anti-inflammatory therapeutic segment, it further said. Celecoxib is a selective COX-2 inhibitor used for the management of pain and inflammation associated with various conditions including osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea. Celecoxib Capsules, 100 mg, 200 mg, and 400 mg have a combined market size of $116 Mn as per IMS.
Business Upturn
30-04-2025
- Business
- Business Upturn
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
