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.