Strides receives USFDA approval for Potassium Chloride Extended Release tablets

Strides Pharma Science Limited (Strides) recently announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Potassium Chloride Extended Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg) from the United States Food & Drug Administration (US FDA).

This is the second Extended Release product approval for Strides and the company has a strong pipeline of products leveraging its capability in the Extended Release delivery technology. Potassium Chloride Extended-Release tablets is a generic version of Klor-Con Extended Release Tablets of Upsher-Smith and Strides is the first Indian generic company to receive this approval.

According to IQVIA MAT data, the US market for Potassium Chloride Extended Release Tablets is approximately US$ 60 mn. The product will be manufactured at the company’s facility at Bengaluru and marketed by Strides Pharma in the US Market.

The company has 78 cumulative ANDA filings with USFDA of which 52 ANDAs have been approved as of date and 26 are pending approval.

-----------------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.