Zydus Lifesciences Surges on US FDA Approval for Enzalutamide Production

7 Mar 2024 , 01:34 PM

Zydus Lifesciences Ltd saw a 2% surge in its share price, hitting a fresh 52-week high on Thursday following positive developments at its Ahmedabad facility. The United States Food and Drug Administration (FDA) issued a favourable “post-application action letter” after inspecting the facility, indicating readiness for commercial production of Enzalutamide, a medication used to treat prostate cancer.

The inspection, which covered for-cause current Good Manufacturing Practices (cGMP) surveillance and pre-approval inspection for Enzalutamide, took place from December 14-22, 2023. Zydus Lifesciences informed the stock exchanges about this development in a filing.

The receipt of a positive post-application action letter from the US FDA signifies that the inspected facility is deemed ready for the commercial manufacture and supply of Enzalutamide API.

This positive news propelled the shares of Zydus Lifesciences, witnessing a rise of up to 2.08% to reach a 52-week high of ₹982.1 apiece on the BSE, consequently elevating the company’s market valuation to over ₹99,000 Crore.

Earlier in January, Zydus Lifesciences’ wholly-owned subsidiary secured an exclusive licensing and supply arrangement with Synthon for Palbociclib Tablets, targeting the US market. This collaboration with Synthon, the initial and sole Abbreviated New Drug Application (ANDA) filer for Palbociclib Tablets in various strengths, could potentially qualify for 180 days of exclusivity for generic drug distribution.

Moreover, in December 2023, Zydus Lifesciences announced its approval from the US health regulator to market a generic product addressing a rare blood condition.

As of 11:39 AM, shares of Zydus Lifesciences were trading 1.35% higher at ₹974.85 apiece on the NSE.