Strides Pharma receives USFDA nod for Flucytosine capsules

Strides Pharma Science Limited informed the bourses on Monday that it's wholly-owned subsidiary-Strides Pharma Global Private Limited (Singapore) has received an approval for Flucytosine capsules USP, 250 mg and 500 mg from United States Food & Drug Administration (USFDA).

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

Strides Pharma Science is a vertically integrated global pharmaceutical company engaged in the development and manufacturing of active pharmaceutical ingredients (APIs) and formulations as well as biotech. Its business segments include pharmaceutical and biotech businesses. The company has 123 cumulative ANDA filings with USFDA of which, 86 ANDAs have been approved and 37 are pending approvals. 

On Monday, the stock closed at Rs 339.50, down by 1.47 per cent or Rs 5.05 per share. The 52-week high is recorded at Rs 547.35 and the 52-week low is Rs 271 on BSE.