Synopsis:- A pharma stock surged 7.34% after securing USFDA approval for its ANDA of Brivaracetam Oral Solution, 10 mg/mL. Trading near Rs 208 with a Rs 1,924 crore market cap, margins improved from 3% to 7%, while export markets contributed 36% each from Europe and emerging regions.
The shares of the prominent pharma company gained up to 7.34 percent in today’s trading session after the company received final approval for its Abbreviated New Drug Application (ANDA).
With a market capitalization of Rs 1,924.07 crore, the shares of Indoco Remedies Ltd were trading at Rs 208.45 per share, increasing around 4 percent as compared to the previous closing price of Rs 199.35 apiece.
ANDA Approval
The shares of Indoco Remedies Ltd have seen positive movement after receiving final approval from the U.S. Food and Drug Administration for its ANDA for Brivaracetam Oral Solution, 10 mg/mL. The approval allows the company to market a generic version equivalent to the reference drug, Briviact 10 mg/mL, originally developed by UCB Inc. in the United States market.
Moreover, the product has been confirmed as bioequivalent and therapeutically equivalent to the reference listed drug, ensuring similar safety and efficacy standards. It will be manufactured at the company’s L-14 facility in Verna, Goa. Brivaracetam is an anticonvulsant prescribed for treating partial-onset seizures in patients aged one month and above. Commenting on the achievement, Ms. Aditi Panandikar, Managing Director, 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.”
Financial & Other Highlights
The company delivered a healthy 8% year-on-year revenue growth, rising from Rs 411 crore in Q3FY25 to Rs 445 crore in Q3FY26, reflecting strong operational momentum. However, despite higher sales, profitability remained under pressure as the net loss widened slightly from Rs 28 crore to Rs 29 crore during the same period.
Between Dec 2024 and Dec 2025, operating performance remained volatile. Operating profit improved from Rs 12 crore in Dec 2024 to Rs 32 crore in Dec 2025, despite fluctuations during the year, including a brief dip into negative territory in March 2025. Similarly, OPM rose from 3% in Dec 2024 to 7% in Dec 2025, reflecting gradual margin recovery.
In Q3 FY26, Indoco Remedies derived a balanced share of export revenue, with Europe and Emerging Markets contributing 36% each, followed by America at 25% and Asia-Australia at 3%. Moreover, within regulated markets, the UK and the USA together formed a dominant portion, highlighting a strong presence in developed regions.
Meanwhile, the domestic market showed healthy regional diversification, led by South India at 35%, followed by West at 29%, East at 20%, and North at 16%. In addition, emerging markets were driven largely by FWA at 51%, with LATAM and Africa contributing 21% and 20%, respectively.
Indoco Remedies Ltd is a Mumbai-based pharmaceutical company engaged in the manufacturing and marketing of formulations and active pharmaceutical ingredients. With a strong presence in both domestic and international markets, the company focuses on regulated and emerging markets, backed by multiple manufacturing facilities and a diversified therapeutic portfolio.
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