Zydus Lifesciences Receives USFDA Approval for Lidocaine and Prilocaine Cream

Zydus Lifesciences Limited has marked another achievement with the USFDA’s final approval for its Lidocaine and Prilocaine Cream USP, 2.5%/2.5%. This topical anaesthetic is used for local analgesia on intact skin and genital mucous membranes. This development reflects Zydus’ commitment to expanding its portfolio in the global healthcare sector. At 12:50 PM on December 19, 2024, Zydus’ share price advanced by 0.55%. 

Strategic Product in a Lucrative Market

Lidocaine and Prilocaine Cream, equivalent to the branded EMLA Cream, addresses a niche yet critical market. The product is utilised for minor surgical procedures and pre-treatment for infiltration anaesthesia. In the United States, the cream generated annual sales of USD 22.05 million as of October 2024 (IQVIA MAT data), highlighting its market potential.

Manufactured in India, Approved for the US

The manufacturing of this product will take place at Zydus’ topical manufacturing site in Changodar, Ahmedabad, a testament to the company’s robust infrastructure and adherence to global standards. This approval underscores Zydus’ capability to compete in the highly regulated US market.

Expanding Regulatory Approvals

This latest approval brings Zydus’ tally to an impressive 412 regulatory nods, with over 473 ANDAs filed since FY 2003-04. It demonstrates the company’s consistent focus on innovation and regulatory compliance, ensuring a steady pipeline of new products for international markets.

About Zydus Lifesciences

With a global workforce of over 27,000, including 1,400 dedicated R&D professionals, Zydus Lifesciences is a leader in healthcare innovation. The company’s mission to empower healthier lives aligns with its extensive portfolio of therapies and breakthrough discoveries.

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