Indoco Remedies jumps 7% post USFDA approval for Brivaracetam oral solution

Indoco Remedies said it received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution, 10 mg/mL

Shares of Indoco Remedies rose over 7 per cent on Tuesday after the US Food and Drug Administration (USFDA) gave a final approval for the company's Brivaracetam oral solution. 

 

The company's stock rose as much as 7.2 per cent during the day to ₹214.9 per share, the biggest intraday rise since February 3 this year. The stock pared gains to trade 4.1 per cent higher at ₹208.1 apiece, compared to a 1.08 per cent decline in Nifty 50 as of 12:37 PM. 

 

Shares of the company rose for the second straight session and currently trade at 5.9 times the average 30-day trading volume, according to Bloomberg. The counter has fallen 11.5 per cent this year, compared to a 2.6 per cent decline in the benchmark Nifty 50. Indoco Remedies has a total market capitalisation of ₹1,918.53 crore. 

Indoco Remedies receives approval from US FDA

The company said it received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution, 10 mg/mL.

 

The approval allows the company to market a generic version of Briviact 10 mg/mL of UCB, Inc., it said in the exchange filing. The product has been determined to be bioequivalent and therapeutically equivalent to the reference listed drug.

 

Brivaracetam Oral Solution, 10 mg/mL, is a prescription antiepileptic drug used for the treatment of partial-onset seizures in patients aged one month and older. The product will be manufactured at the company’s facility in Verna Industrial Area, Goa.

 

Aditi Panandikar, Managing Director, said the ANDA approval for Brivaracetam marks a significant milestone as the company continues to strengthen its presence in regulated markets and remains committed to providing innovative and affordable healthcare solutions globally.

 

Last month, the USFDA gave approval for Indoco Remedies for Lacosamide Oral Solution USP, 10 mg/mL, to market, a generic equivalent to the reference listed drug (RLD), Vimpat Oral Solution, 10 mg/mL, of UCB, Inc. Lacosamide Oral solution is used to treat partial onset seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy who are at least 4 years old.

Indoco Remedies Q3 results 

Indoco Remedies reported a net loss of ₹29.79 crore for the quarter ended December 2025, compared with a net loss of ₹26.39 crore in the corresponding quarter last year. Revenue from operations rose 7.92 per cent to ₹434.34 crore in the reporting quarter, up from ₹402.45 crore in the quarter ended December 2024.