Alembic Pharmaceuticals Secures USFDA Final Approval for Brexpiprazole Tablets

Alembic Pharmaceuticals Limited, founded in 1907, stands as a premier, research-driven pharmaceutical company headquartered in India and publicly listed. Renowned for its expertise in branded generics, Alembic excels in the production and global distribution of high-quality generic medicines. Its state-of-the-art research and manufacturing facilities are endorsed by leading regulatory authorities, including the US Food and Drug Administration (USFDA).

Final Approval from the USFDA

Alembic Pharmaceuticals has announced that it has secured Final Approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Brexpiprazole Tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.

This approved ANDA is deemed therapeutically equivalent to the reference listed drug (RLD), Rexulti Tablets, manufactured by Otsuka Pharmaceutical Company, Ltd. Brexpiprazole is a sophisticated atypical antipsychotic used as an adjunctive therapy alongside antidepressants for managing major depressive disorder (MDD) in adults. It is also indicated for the treatment of schizophrenia in adults and adolescents aged 13 years and above.

Q2 FY25 Results

Alembic Pharmaceuticals reported a 12% YoY rise in Q2 FY25 net profit to ₹153 crore, driven by strong domestic and US sales, with revenues up 3% to ₹1,648 crore. Domestic formulations grew 6% to ₹609 crore, while the US generics segment rose 6% to ₹467 crore, aided by new launches. 

International formulations outside the US saw an 18% growth to ₹298 crore, while the animal health division grew 20% to ₹118 crore. However, API revenues declined 15% to ₹274 crore due to pricing pressures, and EBITDA margins slipped to 15.6%. The company expects upcoming US launches to bolster future growth.

Share Price Performance 

At 1:50 PM today, Alembic Pharmaceuticals Ltd. shares traded at ₹999.50 per share on the NSE.

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