Zydus Gets USFDA Nod for Enzalutamide Tablets Production

On October 2, 2024, Zydus Lifesciences Limited (including its subsidiaries/affiliates, collectively called “Zydus”) received tentative approval from the USFDA to produce Enzalutamide Tablets in 40 mg and 80 mg doses (a generic version of Xtandi® Tablets). 

These tablets are used to treat patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. The tablets will be manufactured at Zydus’ facility in SEZ, Ahmedabad. Enzalutamide Tablets had annual sales of USD 1,417.2 million in the U.S. as of July 2024. Zydus now holds 400 approvals and has filed over 465 ANDAs since FY 2003-04.

In their recent press release on October 1, 2024, the company received the EIR (Establishment Inspection Report) from the USFDA for the inspection conducted at its transdermal patch manufacturing facility in Pharmez, Ahmedabad. The examination took place from July 15 to 19, 2024, and the facility has been classified as Voluntary Action Indicated (VAI).

Financial Highlights

Zydus Lifesciences reported a 31% increase in its consolidated net profit, reaching ₹1,420 crore in the first quarter of June 2024, driven by strong sales. Last year, the company posted a net profit of ₹1,087 crore for the same April-June period. Revenue from operations rose to ₹6,207 crore, compared to ₹5,140 crore in the June quarter of FY24. Zydus’ India sales grew 15% to ₹2,212 crore, up from ₹1,921 crore a year earlier. US formulation sales increased 26% to ₹3,093 crore in Q1, compared to ₹2,454 crore in the same period last year.

About Zydus Lifesciences Limited

In 1995, the group underwent a restructuring, leading to the formation of Cadila Healthcare under the Zydus Group. Starting with a modest turnover of ₹250 crore in 1995, the group saw impressive financial growth, reaching over ₹14,253 crore by FY20. Committed to its mission of improving lives, Zydus continues to innovate and address unmet healthcare needs while working towards building healthier, happier communities worldwide. It is now one of the top five pharmaceutical companies in India.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.