Shares of Zydus Lifesciences hit a 52-week high of Rs 1,203 on 11 July after the company announced that the US Food and Drug Administration (USFDA) had approved two of its drugs.

In its regulatory filing, the company said that its diroximel fumarate delayed-release capsules had secured tentative approval from the USFDA. This drug is used to treat relapsing forms of multiple sclerosis (MS) in adults and will be manufactured at the company’s formulation manufacturing facility in Ahmedabad SEZ, India. 

According to IQVIA MAT, in May 2024, proximal fumarate-containing delayed-release capsules had annual sales of $847.4 million in the US.

In a separate filing, the company announced that they have received final approval to market sacubitril and valsartan tablets. 

Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation. The drug will be made in the company’s formulation manufacturing facility in Ahmedabad, Moraiya, India.

IQVIA MAT May 2024 reports that the combination medication generated $5,483 million in sales in the US annually. 

Since the filing procedure began in FY 2003–04, the group has filed over 460 ANDAs and currently has 399 approvals.

At 1:48 pm, the shares of Zydus Lifesciences shed all its early gains and were trading 1.81% lower at Rs 1,158.75 on NSE.

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