Strides receives USFDA approval for Pregabalin Capsules

Strides Pharma Science Limited (Strides) today announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Pregabalin capsules, 25 mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg. from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Lyrica capsules of Upjohn US. It is used in the treatment of fibromyalgia.

The Pregabalin capsules has a market size of ~US$248 Mn per IQVIA. The product will be manufactured at the company's facility in Puducherry.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 235+ 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. 685.75 as compared to the previous close of Rs. 670.50. The total number of shares traded during the day was 12574 in over 656 trades.

The stock hit an intraday high of Rs. 688.95 and intraday low of 661.05. The net turnover during the day was Rs. 8587311.00.

Source : Equity Bulls

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StridesPharmaScience INE939A01011 StridesPharmaGlobal Singapore USFDA Approval PregabalinCapsules