Express Pharma

Strides Shasun gets US FDA nod for generic of Amgen’s Sensipar tabs

0

Cinacalcet hydrochloride tablet is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis

Shasun announced that its wholly owned subsidiary Strides Pharma Global Pte. Ltd 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.

According to IQVIA data, the US market for cinacalcet hydrochloride tablets is approximately US $ 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 US FDA of which 47 ANDAs have been approved as of date and 27 are pending approval.

Comments are closed.