Drug Approval | April 20, 2026
Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid
The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics
The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics
PMDA is regarded among the most stringent regulatory bodies globally
Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions
No adverse events reported; recall involves 5 mg 500-count bottles in the US market
Multi-year CDMO partnership combines AI-led virtual development, precision chemistry and GMP manufacturing to accelerate five high-science APIs across regulated markets
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
Certification by TÜV SÜD Product Service GmbH reinforces the company's commitment to globally benchmarked standards in safety, quality, and performance
The partnership has already launched with five active development programs, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework
Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug (anticonvulsant) used for treatment of partial-onset seizures in patients 1 month of age and older
Operational leverage kicked in during the quarter, with adjusted EBITDA rising 21% year-on-year to Rs 147 crore
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