Strides Pharma Science’s arm gets USFDA’s nod for Generic Suprep Bowel Prep Kit

23 Nov 2023 Evaluate

Strides Pharma Science’s step?down wholly owned subsidiary -- Strides Pharma Global, 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 $143 Million per IQVIA. The Product will be manufactured at the company’s facility in Bengaluru.

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.


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