Zydus Lifesciences Shares in Focus: Received Final Approval From US FDA

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Fludrocortisone Acetate Tablets USP, 0.1 mg (USRLD: Florinef Tablets, 0.1 mg). This approval marks a significant milestone for Zydus, as it expands its portfolio of generic medications and solidifies its presence in the US market.  

Fludrocortisone acetate tablets are used to treat primary and secondary adrenocortical insufficiency in Addison’s disease and for the treatment of salt-losing adrenogenital syndrome. The tablets will be manufactured at Zydus’ manufacturing site at Moraiya, Ahmedabad, India.  

With this approval, Zydus’ annual sales in the United States are expected to increase by USD 19.9 million, based on IQVIA MAT July 2024 data. This is a significant boost to Zydus’ revenue and profitability.

Since the commencement of the filing process in FY 2003-04, Zydus has filed over 465 ANDAs with the USFDA and has received approval for 400 of them. This demonstrates Zydus’ strong track record in developing and manufacturing high-quality generic medications.

Zydus’ receipt of final approval for Fludrocortisone Acetate Tablets USP, 0.1 mg is a testament to the company’s commitment to providing affordable and accessible generic medications to patients in the United States. Zydus is well-positioned to continue its growth in the US market and to expand its portfolio of generic medications.

On October 18, 2024, Zydus Lifesciences shares opened at ₹1,025.05 and touched the day high of ₹1,028.00 at 09:55 AM. 

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.