Strides receives USFDA approval for Generic Suprep® Bowel Prep Kit

Strides Pharma Science Limited (Strides) today announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Sodium Sulphate, Potassium Sulphate and Magnesium Sulphate Oral Solution 17.5g/ 3.13g/ 1.6g per 6 ounces (Product) from the United States Food & Drug Administration (USFDA).

The Product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Suprep Bowel Prep Kit Oral Solution 17.5g/ 3.13g/ 1.6g per 6 ounces of Braintree Laboratories Inc. (Braintree). The approval bolsters the Company's portfolio of products in bowel preparation that spans both prescription and over the counter offerings.

The Product has a market size of ~US$143 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. 486.45 as compared to the previous close of Rs. 495.75. The total number of shares traded during the day was 32237 in over 1485 trades.

The stock hit an intraday high of Rs. 497.65 and intraday low of 484.40. The net turnover during the day was Rs. 15807542.00.

Source : Equity Bulls

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StridesPharmaScience INE939A01011 StridesPharmaGlobal USFDA Approval