Zydus Lifesciences Limited has received final approval from the U.S. Food and Drug Administration (USFDA) for the production of Lidocaine and Prilocaine Cream USP, 2.5 percent/2.5 percent, the company announced today. The cream, a generic version of EMLA Cream, will be manufactured at the company’s local manufacturing facility in Changodar, Ahmedabad.
Shares of Zydus Lifesciences Limited were trading at ₹984.60 at 2:50 PM today, up ₹5.05 or 0.52 percent on the NSE.
The product is a local anesthetic used for local pain relief on normal skin and genital mucous membranes during minor surgical procedures. According to data from IQVIA, the cream recorded annual sales of $22.05 million in the United States as of October 2024.
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This approval marks Zydus’s 412th USFDA approval since the company began filing Abbreviated New Drug Applications (ANDAs) in fiscal year 2003-2004. The company has filed more than 473 ANDAs to date, demonstrating its significant presence in the U.S. generic drug market.
Zydus Lifesciences, which employs more than 27,000 people worldwide, including 1,400 scientists in R&D, focuses on the development and production of healthcare therapies. The Ahmedabad-based pharmaceutical company has been expanding its portfolio of generic drugs in the US market through regular ANDA filings and approvals.
