Zydus Amantadine ER Capsules gets USFDA okay

Ahmedabad: Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Amantadine Extended-Release Capsules USP 68.5 mg and 137 mg (USRLD: Gocovri).

Amantadine is indicated for the treatment of dyskinesia (sudden uncontrolled movements) in patients with Parkinson's disease who are treated with levodopa therapy, with or without dopaminergic medicines.

The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.

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Amantadine Extended-Release Capsules had annual sales of USD 2.7 mn in the United States, according to IQVIA data (IQVIA MAT Aug 2022). The group now has 325 approvals and has so far filed over 428* ANDAs since the commencement of the filing process in FY 2003-04.

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Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.

Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and in the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.