USFDA approves Strides Pharma's Amantadine Hydrochloride Softgel capsules

21 Feb 2022 , 12:54 PM

Strides Pharma, a step-down wholly-owned subsidiary,  Strides Pharma Global Pte. Limited, Singapore, has received approval for Amantadine Hydrochloride Softgel Capsules USP,100 mg from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Symmetrel Capsules, 100 mg, of Endo Pharmaceuticals, Inc (Endo).

According to IQVIA MAT December 2021 data, the US market for Amantadine Hydrochloride Capsules USP,100 mg is approximately US$ 11 Mn.

The product will be manufactured at the company’s facility in Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

The company also has approval for Amantadine Hydrochloride tablets and the combined market size of Tablets and Capsules together is approximately US$ 21 Mn as per IQVIA MAT December 2021 data.

The company has 271 cumulative ANDA filings with USFDA of which 244 ANDAs have been approved and 27 are pending approval.

At around 12.52  PM, Strides was trading at Rs360.90 per piece down by 1.01% on BSE.