Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval from the United States Food and Drug Administration (USFDA) for Celecoxib Capsules in strengths of 100 mg, 200 mg, and 400 mg.
According to Strides, the product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Celebrex Capsules, in the same strengths, which is marketed by Upjohn US 2 LLC.
Celecoxib is a selective COX-2 inhibitor and is classified as a nonsteroidal anti-inflammatory drug (NSAID). It is prescribed for the management of pain and inflammation linked to conditions such as osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhoea. It works by reducing the production of hormones that cause pain and inflammation in the body.
The company stated that the approval of Celecoxib Capsules strengthens its presence in the anti-inflammatory therapeutic segment and complements its existing products in this category. Strides added that this development enhances its ability to provide treatment options across a broader patient population.
Strides also noted that Celecoxib Capsules in the approved strengths represent a combined market size of approximately US$ 116 million, based on IMS data.
The product will be manufactured at the company’s facility located in Puducherry, India.