Strides Strengthens U.S. Market Position with Celecoxib Capsule Approval

The U.S. Food & Drug Administration has approved Celecoxib capsules to market in values of 100 mg, 200 mg, and 400 mg, proceeded by the Singapore-based entirely-owned subsidiary of Strides Pharma, Strides Pharma Global Pte. Ltd.

This standard version is therapeutic and bioequivalent to Celebrex capsules, the reference-listed drug developed by Upjohn US 2 LLC. Based on the latest approval, Strides significantly expands its impression in the anti-inflammatory sector, adding to its current product portfolio and furthering its mission to deliver cost-effective and high-quality treatments.

The capsule strength is valued at around $116 million in the total U.S. market. According to IMS data, Celecoxib, the particular COX-2 inhibitor, is a broadly used NSAID specified for the treatment of pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, acute pain, and menstrual pain.

The approved product will be manufactured at Strides' facility in Puducherry, India, which is already approved for U.S. exports. The addition of Celecoxib develops Strides’ position as a main player in the U.S. generics market, especially in the high-demand anti-inflammatory therapy class.