May 2: Bangalore-headquartered drug maker Strides Shasun Ltd on Wednesday announced that its wholly owned subsidiary Strides Pharma Global Pte. Ltd has received final approval for its Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base), and 90 mg (base) from the United States Food & Drug Administration (USFDA).
According to the company, Cinacalcet Hydrochloride Tablets is a generic version of Sensipar Tablets of Amgen Inc.
“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,” it said.
According to IQVIA data, the US market for Cinacalcet Hydrochloride Tablets is approximately USD 1.8 Billion.
The Company has 74 cumulative ANDA filings with USFDA of which 47 ANDAs have been approved as of date and 27 are pending approval.