Tuesday, 19 September 2017

Kidney stone drug from Strides Shasun receives USFDA approval

12 September 2017 | News

The product, which is the first approval for an Extended Release tablet for the Company, will be launched immediately.

Courtesy- Wikimedia

Courtesy- Wikimedia

Strides Shasun Limited has received approval from the United States Food & Drug Administration (USFDA) for Potassium Citrate Extended-Release Tablets USP, 5 mEq, 10 mEq, and 15 mEq

According to IMS data, the US market for Potassium Citrate is approximately USD 110 Million.  Strides Shasun will be the second generic player to commercialize the product.

The product, which is the first approval for an Extended Release tablet for the Company, will be launched immediately.

Potassium Citrate, a urinary alkalinizing agent, is used for preventing certain types of kidney stones.  It works by neutralizing some of the acid in the urine, which helps reduce the formation of crystals

Extended release pill is formulated in such a way that the drug is released slowly over time. This has the advantage of taking pills less often and fewer side effects, as the levels of the drug in the body are more consistent.

Strides Shasun is a vertically integrated global pharmaceutical Company headquartered in Bangalore.  The Company has four business verticals, viz., Regulated Markets, Emerging Markets, Institutional Business and Active Pharmaceutical Ingredients.

The Company has global manufacturing foot print with 9 manufacturing facilities spread across three continents including 7 US FDA approved facilities and 2 facilities for the emerging markets. The Company has two dedicated R&D facilities in India with global filing capabilities and a strong commercial footprint across 100 countries.

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