Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) Alcaftadine Ophthalmic Solution.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lastacaft Solution of AbbVie Inc.
Alcaftadine Ophthalmic Solution is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Alembic has a cumulative total of 216 ANDA approvals (189 final approvals and 27 tentative approvals) from USFDA.
Alembic Pharmaceuticals is in the business of development, manufacturing, and marketing of pharmaceutical products, i.e. formulations and active pharmaceutical ingredients.
The pharmaceutical companys consolidated net profit increased 11.69% to Rs 134.71 crore in Q1 FY25 as compared to Rs 120.60 crore posted in Q1 FY24. Revenue from operations grew 5.09% year on year (YoY) to Rs 1,561.73 crore in the quarter ended 30 June 2024.
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