Zydus Lifesciences shares surge on USFDA nod for generic drug

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, has received a green signal from the US health regulator to market a generic product, according to a stock market filing.

"Zydus has received final approval for levothyroxine sodium for injection, 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial from the United States Food and Drug Administration (USFDA)," the company said in a BSE statement.

Levothyroxine sodium injection is used for the treatment of myxedema coma. The drug will be manufactured at Zydus' injectable manufacturing facility at Jarod, near Vadodara in India.

Simultaneously, the company has also got a approval for doxepin hydrochloride capsules USP of strength 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg from USFDA.

"Doxepin hydrochloride capsule is recommended for the treatment of Psychoneurotic patients with depression and/or anxiety, Depression and/or anxiety associated with alcoholism and organic disease, and Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India)," the company said.

After these two approvals, Zydus has a total of 355 approvals and has so far filed over 440 ANDAs (as of 31 December 2022). The company started the filing process in FY 2003-04.

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Zydus share price

Shares of Zydus were trading at Rs 482.65 each, up 0.10 per cent on BSE on Tuesday, 28 March at 12.50 PM. The pharma stock opened at Rs 478.60 apiece and hit the day's high at Rs 483.90. The company's shares have provided returns of over 36 per cent in the last one year and almost 15 per cent on a year-to-date (YTD) basis. Zydus has a current market capitalisation of Rs 48,854.03 crore.

What does Zydus do?

Ahmedabad-headquartered Zydus is primarily engaged in the manufacturing of specialty and generic drugs and makes products like active pharmaceutical ingredients, human formulations, health and wellness, and animal health and veterinary products. Some of its brands include Falcigo, Nucoxia, Aten, Levoday, Metscore and Arzep among others.  

ALSO READ: Zydus Lifesciences gets US health regulator's nod for its generic medicine