Strides Shasun receives US FDA approval for potassium citrate ER tablets

Our Bureau, BengaluruTuesday, September 12, 2017, 14:50 Hrs  [IST]

Strides Shasun  has received approval from the United States Food & Drug Administration (FDA) 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 US$ 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.
The Bengaluru based company has  four business verticals:  regulated markets, emerging markets, institutional business and active pharmaceutical ingredients.