Zydus Lifesciences Limited has received final approval from the US Food and Drug Administration (USFDA) to manufacture Lidocaine and Prilocaine Cream USP, 2.5 per cent/2.5 per cent, the company announced today. The cream, which is a generic version of EMLA Cream, will be produced at the company’s topical manufacturing facility in Changodar, Ahmedabad.
The shares of Zydus Lifesciences Limited were trading at ₹984.60 up by ₹ 5.05 or 0.52 per cent on the NSE today at 2.50 pm
The product is a topical anesthetic used for local pain relief on normal skin and genital mucous membranes during minor surgical procedures. According to IQVIA data, the cream recorded annual sales of $22.05 million in the United States as of October 2024.
This approval marks Zydus’s 412th USFDA approval since the company began filing Abbreviated New Drug Applications (ANDAs) in FY 2003-04. The company has filed over 473 ANDAs to date, demonstrating its significant presence in the US generic drug market.
Zydus Lifesciences, which employs over 27,000 people globally, including 1,400 scientists in R&D, focuses on developing and manufacturing 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.
