Strides Pharma Science announced that its step]down wholly owned subsidiary, Strides Pharma Global, 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.
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