Zydus Lifesciences gains nearly 4% on USFDA nod for Parkinson’s treatment drug; check details

Zydus Lifesciences informed the exchanges on August 27 that it has received final approval from the US drug regulator to market Amantadine 68.5 mg extended-release capsules. The company also said that it has received tentative approval for marketing Gocovri (Amantadine) 68.5 mg and 137 mg extended-release capsules.

Amantadine capsules are used in the treatment of dyskinesia in patients with Parkinson’s disease who are receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

Zydus Lifesciences said that the drug will be manufactured at the company’s manufacturing facility located in Ahmedabad SEZ-II.

The company mentioned in the release that the USFDA approval makes Zydus eligible for 180 days of exclusivity for Amantadine extended release capsules, 68.5 mg. The company said that the group has 400 approvals and has so far filed over 465 Abbreviated New Drug Application (ANDAs) since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences informed the exchanges on August 24 via a release that it will acquire 50% shareholding in Sterling Biotech Limited (SBL) from its wholly owned subsidiary Perfect Day Inc. Post the transaction, Sterling Biotech will become a 50:50 Joint Venture (JV) with equal representation on the Board. Sterling Biotech Ltd is currently engaged in manufacturing and selling of fermentation-based Active Pharmaceutical Ingredients (API) products and gelatine.

As part of the JV, the company will establish a facility to manufacture fermented animal-free protein. The acquisition will also mark the pharma company’s foray into specialised biotech products for health and nutrition.

Zydus Lifesciences shares are trading at ₹1,131 apiece, up 1.58% on the NSE at 1:15 pm.