Strides receives USFDA approval for Potassium Chloride Extended Release Tablets
Deepthi | Myequity news | Date : 05-09-2018 12:00:00 IST
Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Potassium Chloride Extended Release Tablets USP, 8mEq (600mg) and 10mEq (750mg) from the United States Food & Drug Administration (US FDA). This is the second Extended Release product approval for Strides and the company has a strong pipeline of products leveraging its capability in the Extended Release delivery technology. Potassium Chloride Extended-Release tablets is a generic version of Klor-Con Extended Release Tablets of Upsher-Smith and Strides is the first Indian generic company to receive this approval.
According to IQVIA MAT data, the US market for Potassium Chloride Extended Release Tablets is approximately US$ 60 Mn. The product will be manufactured at the company’s facility at Bangalore and marketed by Strides Pharma Inc. in the US Market.
The company has 78 cumulative ANDA filings with USFDA of which 52 ANDAs have been approved as of date and 26 are pending approval.
Potassium Chloride Extended Release Tablets are used for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. Extended release tablet 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.About Strides:
Strides, is global pharmaceutical Company headquartered in Bangalore. The Company has two business verticals, viz., Regulated Markets and Emerging Markets. The Company has a global manufacturing footprint with 7 manufacturing facilities spread across three continents including 5 facilities for Regulated Markets and 2 facilities for the Emerging Markets. The Company has strong R&D infrastructure in India with global filing capabilities and a strong commercial footprint across 100 countries.