Strides Pharma Science’s arm gets USFDA’s nod for Ethosuximide Softgel Capsules
20th Feb 2019

Strides Pharma Science’s step-down wholly owned subsidiary -- Strides Pharma Global Pte., Singapore, has received approval for Ethosuximide Softgel Capsules USP, 250 mg from the United States Food & Drug Administration (USFDA). The product was approved in the first review cycle by the USFDA in less than 10 months of filing under the GDUFA II regime. The product is a generic version of Zarontin Capsules, 250 mg, of Pfizer Inc.

The product will be manufactured at flagship facility in Bangalore and will be marketed by Strides Pharma Inc. in the US market. The company has 86 cumulative ANDA filings with USFDA of which 57 ANDAs have been approved including 13 approvals received in FY-19.

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.