Strides gets USFDA nod for Flucytosine Capsules
Bangalore: Strides Pharma Science Limited today 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.
According to IQVIA MAT data, the US market for Flucytosine Capsules USP, 250 mg and 500 mg are 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.
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).
Strides is a global pharmaceutical company headquartered in Bangalore, India. The Company mainly operates in the regulated markets and has an "in Africa for Africa" strategy along with an institutional business to service donor‐funded markets.
The Company's global manufacturing sites are located in India‐ Bangalore (two locations), Pondicherry, and Chennai, Singapore, Italy‐ Milan, Kenya‐ Nairobi and United States‐Florida.