Strides gets USFDA approval for Flucytosine capsules

PTI Bengaluru | Updated on April 20, 2020 Published on April 20, 2020

Strides Pharma Science Limited (Strides) on Monday announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Flucytosine Capsules USP, 250 mg and 500 mg from the United States Food & Drug Administration (USFDA).

The product is a generic version of Ancobon Capsules, 250 mg and 500 mg, of Bausch Health US, LLC, the Bengaluru- headquartered pharmaceutical company said in a statement.

The product will be manufactured at the company’s flagship facility here and marketed by Strides Pharma Inc. in the US market.

The company has 123 cumulative ANDA (Abbreviated New Drug Application) filings with USFDA of which 86 have been approved and 37 are pending approval, the statement added.

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Published on April 20, 2020
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