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Pharmaceuticals
USFDA10 May 2024, 05:58 pm

Strides Pharma Science Ltd Receives USFDA Approval for Sevelamer Carbonate Tablets, 800 mg

AI Summary

Strides Pharma Science Ltd announced that its subsidiary, Strides Pharma Global Pte. Ltd, has received approval from the USFDA for Sevelamer Carbonate Tablets, 800 mg. This product, a phosphate binder, is bioequivalent and therapeutically equivalent to Renvela® Tablets, 800 mg. The market size for Sevelamer Carbonate Tablets is ~USS 181 Mn. This approval strengthens Strides' presence in the Sevelamer portfolio, complementing the existing approval of Sevelamer Carbonate Powder for Oral Suspension. The tablets will be manufactured at Strides' facility in Puducherry. Strides currently has 245+ ANDAs approved out of 260 cumulative filings and a target to launch ~60 new products over three years in the US.

Key Highlights

  • Strides Pharma Science Ltd receives USFDA approval for Sevelamer Carbonate Tablets, 800 mg
  • Product is bioequivalent and therapeutically equivalent to Renvela® Tablets, 800 mg
  • Sevelamer Carbonate Tablets have a market size of ~USS 181 Mn
  • Approval strengthens Strides' presence in the Sevelamer portfolio
  • Tablets will be manufactured at Strides' facility in Puducherry
  • Strides has 245+ ANDAs approved out of 260 cumulative filings
STAR
Pharmaceuticals
Strides Pharma Science Ltd

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