In a strategic move to further strengthen its footprint in the anti-inflammatory therapeutic segment, Strides Pharma Science Limited announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured United States Food & Drug Administration (USFDA) approval for Celecoxib Capsules in 100 mg, 200 mg, and 400 mg dosages.
The newly approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Celebrex® Capsules of the same strengths, manufactured by Upjohn US 2 LLC. The USFDA clearance enables Strides to cater to a wider segment of patients with effective and affordable treatment options for pain and inflammation management.
Celecoxib is a selective COX-2 inhibitor, classified under nonsteroidal anti-inflammatory drugs (NSAIDs), and is widely used for conditions such as osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea. With an estimated market size of approximately US$ 116 million as per IMS, the approval positions Strides competitively in a high-demand therapeutic area.
The manufacturing of the product will be carried out at Strides’ Puducherry facility, which is part of the company’s expansive global manufacturing network.
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Headquartered in Bengaluru, India, Strides Pharma Science Limited is a globally recognised pharmaceutical company listed on BSE (532531) and NSE (STAR). Known for its focus on “difficult to manufacture” products, Strides has a strong presence in regulated markets and pursues an “in Africa for Africa” strategy, in addition to serving donor-funded institutional markets.
Strides operates through a diversified global footprint, with manufacturing facilities across India (Bengaluru, Chennai, Puducherry), Italy (Milan), Kenya (Nairobi), and the United States (New York). The company exports its products to over 100 countries, addressing complex medical needs through robust R&D, regulatory compliance, and an unwavering commitment to global health.
The approval of Celecoxib further underscores Strides’ growth trajectory in the pain and inflammation space, reaffirming its commitment to expanding access to critical medications across global markets.
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