Indoco Remedies Share Price Jumps Over 4% After USFDA Approval for Brivaracetam Oral Solution

Indoco Remedies has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution, 10 mg/mL. The approval permits the company to market a generic version of Briviact 10 mg/mL, the reference listed drug of UCB, Inc., in the US market. 

The company disclosed the development to the exchanges on 24 February 2026. 

Product and Market Context 

Brivaracetam Oral Solution, 10 mg/mL, is indicated for the treatment of partial-onset seizures in patients aged 1 month and above. The company, in the filing stated that the product has been found bioequivalent and therapeutically equivalent to the reference drug, a key requirement for generic approvals in the US. 

The drug will be manufactured at Indoco’s facility in Verna Industrial Area, Goa. US approvals remain central to Indian pharmaceutical companies, given the size of the generics market and pricing dynamics. 

Portfolio Expansion in CNS Segment 

The latest clearance follows the USFDA’s recent approval for Indoco’s Lacosamide Oral Solution USP, 10 mg/mL, a generic equivalent to Vimpat Oral Solution. Lacosamide is used for partial-onset seizures and primary generalised tonic-clonic seizures in patients aged 4 years and above. 

With 2 oral solutions approved within a short span, Indoco has added to its central nervous system (CNS) portfolio in regulated markets. 

Indoco Remedies Financial Performance  

For the quarter ended December 2025, Indoco Remedies reported a net loss of ₹29.79 crore, compared with a net loss of ₹26.39 crore in the corresponding quarter last year. Revenue from operations increased 7.92% year-on-year to ₹434.34 crore from ₹402.45 crore. 

The company has an annual turnover of around US$ 180 million and operates 10 manufacturing facilities, including 6 for finished dosage forms and 4 for active pharmaceutical ingredients. 

Indoco Remedies Share Price Performance 

As of February 24, 2026, 1:30 pm, Indoco Remedies share price was trading at ₹206.02, a 4.00% increase from the previous closing price. 

Read More: Indoco Remedies Share Price Gains Over 2%; Gets USFDA Approval for Lacosamide Oral Solution USP! 

Conclusion 

The final ANDA approval adds another CNS product to Indoco’s regulated markets portfolio. The company had received a similar US clearance last month. 

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