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The approval received from US Food & Drug Administration (USFDA) is for its Abbreviated New Drug Application (ANDA) for lidocaine and prilocaine cream USP, 2.5%/2.5%. lidocaine 2.5% and prilocaine 2.5% cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on normal intact skin for local analgesia and genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US$29 million for twelve months ending December 2021 according to IQVIA.
Alembic has received a cumulative total of 163 ANDA approvals (140 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
The pharma company reported 36.6% fall in the net profit to Rs 164.25 crore on 3.2% decline in net profit to Rs 1271.70 crore in Q4 FY22 as against Q4 FY21.
Shares of Alembic Pharmaceuticals were trading 0.81% lower at Rs 769.65 on BSE.
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