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Zydus Lifesciences gets USFDA’s approval for Lidocaine and Prilocaine cream

19 Dec 2024 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Lidocaine and Prilocaine Cream USP, 2.5%/2.5% (USRLD: EMLA Cream, 2.5%/2.5%). Lidocaine and Prilocaine Cream USP is indicated as a topical anaesthetic for use on normal intact skin for local analgesia and genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anaesthesia. 

Lidocaine and Prilocaine cream will be produced at the Group’s topical manufacturing site at Changodar, Ahmedabad. Lidocaine and Prilocaine cream had annual sales of $22.05 million in the United States (IQVIA MAT October 2024). The group now has 412 approvals and has so far filed over 473 ANDAs since the commencement of the filing process in FY 2003-04. 

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

Peers
Company Name CMP
Sun Pharma. Inds. 1748.90
Dr. Reddys Labs. 1214.10
Cipla 1312.85
Lupin 1954.80
Zydus Lifesciences 1124.00
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