Strides gets USFDA nod for Generic Suprep Bowel Prep Kit

The company has set a target to launch ~ 60 new products over three years in the US.;

Published On 2023-11-23 06:00 GMT | Update On 2023-11-23 12:06 GMT

Bangalore: Strides Pharma Science Limited has 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.

"The approval bolsters the Company's portfolio of products in bowel preparation that spans both prescription and over the counter offerings," the release stated.

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.

Sodium Sulphate, Potassium Sulphate and Magnesium Sulphate Oral Solution 17.5g/ 3.13g/ 1.6g per 6 ounces belongs to a group of medicines prescribed to those who are required to undergo a colon cleanse prior to a colonoscopy. The kit is available in a carton containing two 6 ounce bottles of the liquid and a mixing container.

Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor‐ funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on “difficult to manufacture” products sold in over 100 countries.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Strides gets USFDA nod for Generic Suprep Bowel Prep Kit

The company has set a target to launch ~ 60 new products over three years in the US.;

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