Strides Shasun gets USFDA nod for kidney disease capsules

Strides Shasun Limited informed the bourses that its wholly-owned subsidiary Strides Pharma Global Pte. Limited has received final approval for Cinacalcet Hydrochloride Tablets from the United States Food & Drug Administration (USFDA).

Cinacalcet Hydrochloride Tablet is used 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.

Strides Shasun has a global manufacturing footprint with seven manufacturing facilities spread across three continents, including five USFDA approved facilities and two facilities for the emerging markets.

The company has 74 cumulative ANDA filings with USFDA, out of which 46 ANDAs have been approved and 28 are still awaiting approval.

On Wednesday, the stock of Strides Shasun opened at Rs. 644 per share and touched an intra-day high and low of Rs. 644.30, and Rs. 634.75, respectively, on the BSE.