FDA grants Strides Pharma approval for Amantadine Hydrochloride Softgel Capsules, 100mg

Bengaluru : Strides Pharma Science Limited announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for Amantadine Hydrochloride Softgel Capsules USP, 100mg from the United States Food & Drug Administration (US FDA). The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Symmetrel Capsules, 100 mg, of Endo Pharmaceuticals, Inc.

According to IQVIA MAT December 2021 data, the US market for Amantadine Hydrochloride Capsules USP,100mg is approximately $11 million. The product will be manufactured at the company’s facility at 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 $21 million as per IQVIA MAT December 2021 data.