Strides Pharma gets USFDA okay for Amantadine Hydrochloride Softgel Capsules
The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
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Bengaluru: Strides Pharma Science Limited today announced that its 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.
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