Alembic Pharmaceuticals on Tuesday announced that its wholly owned subsidiary, Aleor Dermaceuticals has received final approval from the USFDA lidocaine and prilocaine cream.
Lidocaine and prilocaine is indicated as a topical anesthetic for use on normal intact skin for local analgesia and genital mucous membranes for superficial minor surgery. The cream is also used as pretreatment for infiltration anesthesia.The approved drug is therapeutically equivalent to the reference listed drug product EMLA Cream of Teva Branded Pharmaceutical Products R&D. According to IQVIA, lidocaine and prilocaine cream has an estimated market size of $29 million for twelve months ending December 2021.
Alembic has now received a cumulative total of 163 ANDA approvals (140 final approvals and 23 tentative approvals) from USFDA.
Shares of Alembic Pharmaceuticals were trading 0.81% lower at Rs 769.65 on BSE.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
On a consolidated basis, the company reported a 39.7% fall in net profit to Rs 176.42 crore on a 3.2% fall in net sales to Rs 1,271.7 crore in Q3 FY22 over Q3 FY21.
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