Strides Pharma’s arm gets USFDA’s approval for Flucytosine Capsules

20 Apr 2020 Evaluate
Strides Pharma Science’s step?down wholly?owned subsidiary Strides Pharma Global Pte 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.

According to IQVIA MAT data, the US market for Flucytosine Capsules USP, 250 mg and 500 mg is approximately US$ 45 Mn. 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 USFDA of which 86 ANDAs have been   approved and 37 are pending approval.

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.

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