Shares of Strides Pharma Science added nearly 2 percent intraday Wednesday as company received USFDA approval for Ethosuximide softgel capsules.
The company'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 company 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.
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.
At 12:44 hrs Strides Pharma Science was quoting at Rs 406.20, up Rs 3.30, or 0.82 percent on the BSE.
For more market news, click here First Published on Feb 20, 2019 12:51 pm
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