Strides receives USFDA approval for Levetiracetam Oral Solution

Strides Pharma Science Limited (Strides) today announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Levetiracetam Oral Solution USP, 100 mg/mL, from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Keppra Oral Solution, 100 mg/mL of UCB, Inc. It is used in the treatment of seizures.

The Levetiracetam Oral Solution has a market size of ~US$55 Mn per IQVIA. The product will be manufactured at the company's facility in Bengaluru.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.

Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 490.35 as compared to the previous close of Rs. 484.05. The total number of shares traded during the day was 11722 in over 963 trades.

The stock hit an intraday high of Rs. 497.65 and intraday low of 483.00. The net turnover during the day was Rs. 5757699.00.

Source : Equity Bulls

Keywords

StridesPharmaScience INE939A01011 StridesPharmaGlobal Approval LevetiracetamOralSolution USFDA