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Zydus Lifesciences Shares Surge 4% on USFDA Final Approval 

The tablets will be manufactured at the company's manufacturing site at Moriya, Ahmedabad.

Shares of Zydus Lifesciences increased 3.8% to Rs 1156 on Wednesday, 28 August, after the company announced receiving final approval from the US Food and Drug Administration’s (USFDA) to market Amantadine extended-release capsules, 68.5 mg and also received tentative approval for 137 mg.

The drug is a generic copy of the US reference-listed drug Gocovri. 

Amantadine extended-release capsules are used to treat dyskinesia in Parkinson’s disease patients who are receiving levodopa-based therapy, either in conjunction with or apart from concomitant dopaminergic medications. 

The business stated in an exchange filing on Tuesday that the medication will be produced at the group’s formulation manufacturing facility in Ahmedabad SEZ – II, India. 

With this approval, Zydus will have 180 days of exclusive use of Amantadine 68.5 mg extended-release capsules. 

Since the filing procedure began in FY 2003–04, the Zydus group has received 400 approvals and has submitted over 465 new medicine applications, according to the company. 

Strong sales helped Zydus Lifesciences announce a 31% increase in consolidated net profit to Rs 1,420 crore for the April–June quarter of the fiscal year 2024–25 (Q1FY25).

The company’s stock price has soared 78.4% in the past year, and it has increased by 61.8% year to date.

At 12:02 pm, the shares of Zydus Lifesciences were trading 1.30% higher at Rs 1,128.70 on NSE.

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