Strides receives USFDA approval for Amantadine Hydrochloride Softgel 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 Amantadine Hydrochloride Softgel Capsules USP, 100 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Symmetrel Capsules, 100 mg, of Endo Pharmaceuticals, Inc (Endo).

According to IQVIA MAT December 2021 data, the US market for Amantadine Hydrochloride Capsules USP,100 mg is approximately US$ 11 Mn. The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

The company also has approval for Amantadine Hydrochloride tablets and the combined market size of Tablets and Capsules together is approximately US$ 21 Mn as per IQVIA MAT December 2021 data.

The company has 271 cumulative ANDA filings with USFDA of which 244 ANDAs have been approved and 27 are pending approval.

Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 364.90 as compared to the previous close of Rs. 371.30. The total number of shares traded during the day was 22615 in over 1181 trades.

The stock hit an intraday high of Rs. 371.30 and intraday low of 362.00. The net turnover during the day was Rs. 8295625.00.

Source : Equity Bulls

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