Strides receives USFDA approval for Ibuprofen Oral Suspension

Strides Pharma Science Limited (Strides) today announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ibuprofen Oral Suspension USP, 100 mg/5 mL from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil).

According to IQVIA MAT March 2022 data, the US market for Ibuprofen Oral Suspension USP, 100 mg/5 mL is approximately ~US$ 66 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 has 274 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 250 ANDAs have been approved and 24 are pending approval. The company currently has ~60 commercialized products in the US and has set a target to launch ~ 20 new products every year from the combined portfolio.

Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 326.60 as compared to the previous close of Rs. 321.85. The total number of shares traded during the day was 38411 in over 1719 trades.

The stock hit an intraday high of Rs. 330.70 and intraday low of 320.00. The net turnover during the day was Rs. 12546405.00.

Source : Equity Bulls

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StridesPharmaScience INE939A01011 USFDA Approval Ibuprofen OralSuspension