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Pharmaceuticals
USFDA30 Apr 2025, 03:16 pm

Strides Pharma Science Ltd Strengthens Anti-Inflammatory Portfolio with USFDA Approval for Celecoxib Capsules

AI Summary

Strides Pharma Science Limited announced 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. The approval of Celecoxib Capsules strengthens Strides’ portfolio in the anti-inflammatory therapeutic segment and enhances its ability to serve a broader patient population with effective, affordable treatment options. Celecoxib Capsules, 100 mg, 200 mg, and 400 mg have a combined market size of ~USS 116 Mn as per IMS. The product will be manufactured at the company’s facility in Puducherry.

Key Highlights

  • Strides Pharma Science Ltd receives USFDA approval for Celecoxib Capsules, 100 mg, 200 mg, and 400 mg
  • The product is bioequivalent and therapeutically equivalent to the reference listed drug Celebrex® Capsules of Upjohn US 2 LLC
  • The approval strengthens Strides’ portfolio in the anti-inflammatory therapeutic segment
  • The new Celecoxib Capsules have a combined market size of ~USS 116 Mn as per IMS
  • The product will be manufactured at the company’s facility in Puducherry
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Pharmaceuticals
Strides Pharma Science Ltd

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