Zydus Lifesciences share price trading maginally lower in the opening trade on October 3 despite the company received tentative approval from the United States Food and Drug Administration (USFDA) to manufacture Enzalutamide Tablets, 40 mg and 80 mg.
At 09:30am, Zydus Lifesciences was quoting at Rs 1,074.20, down Rs 6.40, or 0.59 percent, on the BSE.
Enzalutamide tablets are androgen receptor inhibitors indicated for the treatment of patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
Enzalutamide tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad.
The group now has 400 approvals and has so far filed over 465 ANDAs (as of June 20, 2024) since the commencement of the filing process in FY 2003-04.
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On October 1, the company received the EIR report from the USFDA for the inspection conducted between 15to 19 July 2024 at its transdermal patch manufacturing facility located at Pharmez, Ahmedabad, which classified as Voluntary Action Indicated (VAI).
On September 28, the company received final approval from USFDA to manufacture Enzalutamide Capsules, 40 mg.
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