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.
Strides specializes in softgel domain and is a global leader in the Rx space. Strides now has a large portfolio of softgel products which now comprises of 10 approved products for the US markets along with a strong product pipeline. Ethosuximide Softgel Capsules is part of Strides niche and small volume product portfolio with limited competition in the US market. According to IQVIA MAT data, the US market for Ethosuximide Softgel Capsules USP, 250 mg is approximately US$ 10 Mn. As part of its portfolio maximization strategy, Strides will also commercialize the product in other geographies leveraging its vast footprint in other regulated markets.
The product will be manufactured at flagship facility in Bangalore and will be marketed by Strides Pharma Inc. in the US market.