Zydus Lifesciences gains on US FDA nod for anti-depressant drug

The company is slated to be included in the Nifty Next 50 index on September 29 of the ongoing fiscal.

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Zydus Lifesciences shares were up by a percent in the morning trade on August 18 after the pharma major announced that it had received the final approval from the United States Food and Drug Administration (USFDA) for its Doxepin tablets.

The company received the final green light for the sale of its Doxepin Tablets in both 3 mg and 6 mg variants. The tablet which belongs to the class of tricyclic antidepressants is used in managing sleep disorders like insomnia. The drug is designed to extend sleep duration and curtail instances of night-time awakenings.

According to a source cited by the company, Doxepin is said to have an annual sales of $43.4 million in the US. The company said that the tablets will be produced at its formulation manufacturing facility in Moraiya, Gujarat.

With this recent approval, Zydus‘ tally of approvals received from USFDA till date climbs to 376. The company said that it had filed over 444 abbreviated new drug applications with the drug-regulator since the start of the filing process in the fiscal year 2003-04.

At 10am on the NSE, the stock was quoting at Rs 653.20, up Rs 8.35, or 1.29 percent.

In its results for Q1FY24, the company reported a 26.19 percent year-on-year (YoY) rise in its revenue from operations at Rs 5,140 crore. Profit after taxes for the June quarter were up 96.87 percent to Rs 1,134 crore. Meanwhile, the operating profit margins expanded by 900 basis points to 29 percent.

The company is slated to be included in the Nifty Next 50 index on September 29 of the ongoing fiscal.

Zydus Lifesciences, formerly known as Cadila Healthcare, is engaged in the manufacturing of generic drugs.

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