Strides Pharma Science Limited (Strides) today announced that its stepdown 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.
The approval of Celecoxib Capsules strengthens Strides' portfolio in the anti-inflammatory therapeutic segment. This approval complements the company's existing products in the same therapy area and enhances its ability to serve a broader patient population with effective, affordable treatment options. 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 ~US$ 116 Mn as per IMS.
The product will be manufactured at the company's facility in Puducherry.
Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 636.45 as compared to the previous close of Rs. 651.40. The total number of shares traded during the day was 15108 in over 1319 trades.
The stock hit an intraday high of Rs. 661.35 and intraday low of 630.00. The net turnover during the day was Rs. 9723835.00.