Shares of Zydus Lifesciences Ltd rose 1.5% to touch a day’s high of Rs 901.30 on 17th March after the firm announced that it had received final approval from the US Food and Drug Administration (USFDA) to manufacture Eluxadoline Tablets, 75 mg and 100 mg.
Eluxadoline is a mu-opioid receptor agonist used in adults to treat irritable bowel syndrome with diarrhoea.
As stated in an exchange filing, Zydus Lifesciences Ltd will manufacture Eluxadoline Tablets, 75 mg and 100 mg, at its SEZ facility in Ahmedabad.
Zydus was among the first ANDA applicants to submit a substantially complete application with a paragraph IV certification for Eluxadoline Tablets, 75 mg and 100 mg.
With this approval, the company is eligible for 180 days of shared generic drug exclusivity for Eluxadoline Tablets, 75 mg and 100 mg.
Eluxadoline tablets recorded annual sales of $243.7 million in the US. Zydus now has 419 approvals and has filed 483 ANDAs since FY 2003-04, as of 31st December 2024.
At 11:04 AM, the shares of Zydus Life were trading 1.34% higher at Rs 894.90 on NSE.
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