Strides Shasun receives USFDA approval for Cinacalcet Hydrochloride Tablets
Strides Shasun Limited today announced that its wholly owned subsidiary Strides Pharma Global Pte. Limited has received final approval for Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base), and 90 mg (base) from the United States Food & Drug Administration (US FDA). Cinacalcet Hydrochloride Tablets is a generic version of Sensipar® Tablets of Amgen Inc. Cinacalcet Hydrochloride Tablet is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis.
Strides Shasun, listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR), is a vertically integrated global pharmaceutical Company headquartered in Bangalore. The Company has two business verticals, viz., Regulated Markets and Emerging Markets. The Company has global manufacturing foot print with 7 manufacturing facilities spread across three continents including 5 US FDA approved facilities 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.
According to IQVIA data, the US market for Cinacalcet Hydrochloride Tablets is approximately USD 1.8 Billion. The product is part of the backward integrated formulations portfolio and will receive API supplies from Solara Active Pharma Sciences under a long term manufacturing agreement. The product will be manufactured at the Company’s Oral dosage facility at Puducherry and will be marketed by Strides Pharma Inc. in the US Market. The Company has 74 cumulative ANDA filings with USFDA of which 47 ANDAs have been approved as of date and 27 are pending approval.
