Strides receives US FDA approval for Amantadine Hydrochloride Softgel capsules
Capsules to be marketed by Strides Pharma Inc in the US market
Strides Pharma Science yesterday announced that its step-down wholly-owned subsidiary, Strides Pharma Global Singapore, has received approval for Amantadine Hydrochloride Softgel capsules USP, 100 mg from the United States Food and Drug Administration (FDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Symmetrel capsules, 100 mg, of Endo Pharmaceuticals, Inc (Endo), Strides said in a statement.
According to IQVIA MAT December 2021 data, the US market for Amantadine Hydrochloride capsules
USP, 100 mg 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 statement further said.
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.
The company has 271 cumulative ANDA filings with US FDA of which 244 ANDAs have been approved
and 27 are pending approval, concluded the statement.
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