Strides Pharma gets USFDA approval for Flucytosine capsules

Strides Pharma Science on 20 April 2020 announced that its step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, has received approval for Flucytosine capsules USP, 250 mg and 500 mg from the US drug regulator.

Flucytosine Capsule is indicated only in the treatment of serious infections caused by susceptible strains of Candida (septicemia, endocarditis and urinary system infections) and/or Cryptococcus (meningitis and pulmonary infections).

The product is a generic version of Ancobon Capsules, 250 mg and 500 mg, of Bausch Health US, LLC. According to IOVIA MAT data, the US market for Flucytosine capsules USP, 250 mg and 500 mg is approximately $45 million. The product will be manufactured at the company's flagship facility at Bangalore and will be marketed by Strides Pharma Inc. in the US market.

The company has 123 cumulative ANDA filings with United States Food & Drug Administration (USFDA) of which 86 abbreviated new drug application (ANDA) have been approved and 37 are pending approval.

Strides Pharma Science is a global pharmaceutical company. It focuses on difficult to manufacture products that are sold in over 100 countries. The company has 123 cumulative ANDA filings with USFDA of which 86 ANDAs have been approved and 37 are pending approval.

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