Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg from the United States Food & Drug Administration (US FDA). Gabapentin Capsules is a generic version of Neurontin Capsules® of Pfizer Inc. The product received approval in the first cycle of review of 10 months under the GDUFA II regime.
According to IQVIA MAT data, the US market for Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg is approximately US$ 270 Mn. The product will be marketed by Strides Pharma Inc. in the US Market.
The company has 78 cumulative ANDA filings with USFDA of which 53 ANDAs have been approved as of date and 25 are pending approval.
Shares of Strides Pharma Science Ltd was last trading in BSE at Rs.424.35 as compared to the previous close of Rs. 433.45. The total number of shares traded during the day was 81766 in over 1770 trades.
The stock hit an intraday high of Rs. 437.5 and intraday low of 417. The net turnover during the day was Rs. 34790168.