Zydus Life gets tentative USFDA nod for Amantadine Capsules

Zydus Life gets tentative USFDA nod for Amantadine Capsules

by admin- Tuesday, October 4th, 2022 06:27:30 PM

Zydus Lifesciences US subsidiary Zydus Pharmaceuticals (USA) Inc. Has received tentative approval from the US Food and Drug Administration (USFDA) to marketplace Amantadine Extended-Release Capsules USP 68.Five mg and 137 mg.

Amantadine is indicated for the remedy of dyskinesia (unexpected out of control actions) in sufferers with Parkinson’s ailment who’re dealt with with levodopa therapy, with or without dopaminergic drugs. The drug can be synthetic on the group’s formula production facility at Ahmedabad SEZ, India.

Amantadine Extended-Release Capsules had annual income of USD 2.7 mn in the United States according to IQVIA statistics.

The institution now has 325 approvals and has to this point filed over 428 ANDAs since the graduation of the filing procedure in FY 2003-04.

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