Shares of Zydus Lifesciences were trading in the red and 1% lower on 3 October despite the company announced receiving tentative approval from the US Food and Drug Administration (USFDA). 

The company, in its regulatory filing, announced receiving tentative approval to manufacture Enzalutamide tablets, 40 mg and 80 mg, which will be manufactured at the company’s Ahmedabad SEZ manufacturing facility.

Enzalutamide tablets are androgen receptor inhibitors and are used to treat patients with metastatic castration-sensitive prostate cancer and castration-resistant prostate cancer. 

As of 20 June 2024, the group had 400 approvals and had filed over 465 ANDAs since the filing procedure started in FY 2003–04.

On 1 October, the company received the USFDA’s EIR report for the inspection of its transdermal patch manufacturing facility in Pharmez, Ahmedabad, from 15 to 19 July 2024. After the inspection, the facility was classified as Voluntary Action Indicated (VAI).

On 28 September, the USFDA gave Zydus Lifesciences final approval to produce 40 mg Enzalutamide Capsules.

At 12:22 pm, the shares of Zydus Lifesciences were trading 0.80% lower at Rs 1,071.60 on NSE.

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