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Zydus Lifesciences Shares Hit 52-Week High on Receiving USFDA Approval

The company stated that it would work closely with the FDA to address and respond to the observations as soon as possible.

Shares of Zydus Lifesciences hit a 52-week high of Rs 893.75 on 16 February after the company announced receiving USFDA approval for Isosorbide Mononitrate Extended-Release tablets.

In its regulatory filing, the company announced that it had received US Food and Drug Administration (USFDA) approval for Isosorbide Mononitrate Extended-Release tablets in USP strength of 30 mg, 60 mg, and 120 mg.

Through this approval, the company will be able to manufacture and sell these tablets in the US market, which will be manufactured at its formulation facility at Ahmedabad SEZ in Gujarat.

Along with the latest approval, the company now has a total approval of 388 and has filed for over 460 abbreviated new drug applications since the fiscal year 2003-04.

In February, the company received tentative approval from the USFDA to manufacture and market Dexamethasone Tablets USP, 1mg, which is used to treat ailments such as blood/hormone disorders, arthritis, skin diseases, eye problems, allergic reactions, cancer, breathing problems, bowel disorders, and immune system disorders.

At 3:30 pm, the shares of Zydus Lifescience closed 1.48% higher at Rs 892 on NSE.

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