The approval allows the company to market a generic version of Briviact 10 mg/mL oral solution, the reference listed drug (RLD) of UCB, Inc.
The company said its Brivaracetam Oral Solution has been determined to be bioequivalent and therapeutically equivalent to the RLD.
The product will be manufactured at Indoco Remedies’ facility located at L-14, Verna Industrial Area, Verna, Goa – 403722, India.
Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug indicated for the treatment of partial-onset seizures in patients aged one month and older.
Aditi Panandikar, managing director (MD) said, “The ANDA approval for Brivaracetam is a significant milestone for us as we continue to strengthen our presence in the Regulated Markets. We are committed to offering innovative and affordable healthcare to patients worldwide.”
Indoco Remedies is engaged in the manufacturing and marketing of Formulations and Active Pharmaceutical Ingredients. The Company caters to both Domestic and International markets.
The company’s consolidated net loss of Rs 23.64 crore in Q3 FY26 as against net loss of Rs 27.30 crore in Q3 FY25. Revenue from operations rose 7.9% year on year to Rs 434.34 crore in Q3 FY26.