Zydus Lifesciences gets USFDA nod for generic Lidocaine and Prilocaine cream; shares trade in green

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market generic Lidocaine and Prilocaine cream.

The US health regulator granted approval for Lidocaine and Prilocaine cream USP, 2.5 per cent/2.5 per cent, Zydus Lifesciences Ltd said in a regulatory filing.

The cream, a topical anaesthetic, is used for local analgesia on normal intact skin and genital mucous membranes for superficial minor surgeries and as a pre-treatment for infiltration anaesthesia.

The product will be manufactured at the company’s topical formulations facility in Changodar, Ahmedabad, Zydus said.

Citing IQVIA data for October 2024, the company noted that Lidocaine and Prilocaine Cream had annual sales of USD 22.05 million in the US market.

With this approval, Zydus now has 412 approvals to its credit and has filed over 473 Abbreviated New Drug Applications (ANDAs) since it began filing in FY 2003-04, the statement added.

Shares of Zydus Lifesciences Ltd were trading at ₹987.80 apiece on the BSE at 2:30 pm, up 0.84% from the previous close.

Zydus Lifesciences is an Indian multinational pharmaceutical company engaged in the discovery, development, and manufacturing of healthcare therapies. It employs over 27,000 people globally, including 1,400 scientists dedicated to research and development.