Indoco Remedies Shares Soar 7% on USFDA Approval for Brivaracetam Oral Solution

• Indoco Remedies Ltd shares surged 7% after receiving USFDA final approval for Brivaracetam Oral Solution, 10 mg/mL.
• The approval allows Indoco to market a generic equivalent of Briviact 10 mg/mL, a reference listed drug by UCB, Inc., in the US.
• Brivaracetam Oral Solution is bioequivalent and therapeutically equivalent to the reference product, used for partial-onset seizures in patients aged one month and older.
• The product will be manufactured at Indoco’s facility in Verna Industrial Area, Goa, which holds regulatory approvals for exports.
• Managing Director Aditi Panandikar highlighted the approval as a significant milestone for strengthening their presence in regulated markets.