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 USD 22.05 mn 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.