The approved drug is a reference listed drug of Gocovri (amantadine) extended-release capsules, 68.5 mg and 137 mg.

The Amantadine extended-release capsules are indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ-II, India.

This approval makes Zydus eligible for 180 days of exclusivity for Amantadine extended-release capsules, 68.5 mg.

The group now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The pharma company’s consolidated net profit surged 30.64% to Rs 1,419.9 crore in Q1 FY25 as compared to Rs 1,086.9 crore posted in Q1 FY24. Revenue from operations jumped 20.77% year on year (YoY) to Rs 6,207.5 crore in the quarter ended 30 June 2024.