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Alembic Pharma receives USFDA nod for Brexpiprazole tablets

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Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Brexpiprazole Tablets.

Brexpiprazole is an atypical antipsychotic used as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, and also used in treatment of schizophrenia in adults and pediatric patients ages 13 years and older. Refer label for a detailed indication.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets, of Otsuka Pharmaceutical Company (Otsuka).

Brexpiprazole tablets have an estimated market size of $ 2 billion for twelve months ending September 2024 according to IQVIA.

 

Alembic has a cumulative total of 220 ANDA approvals (194 final approvals and 26 tentative approvals) from USFDA.

Alembic Pharmaceuticals is in the business of the development, manufacturing, and marketing of pharmaceutical products, i.e., formulations and active pharmaceutical ingredients.

The pharmaceutical companys consolidated net profit increased 12.3% to Rs 153.41 crore in Q2 FY25 as compared to Rs 136.56 crore posted in Q2 FY24. Revenue from operations grew 3.3% year on year (YoY) to Rs 1,647.98 crore in the quarter ended 30 September 2024.

The scrip shed 0.44% to currently trade at Rs 1,004.75 on the BSE.

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First Published: Jan 15 2025 | 2:47 PM IST

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