Indoco Remedies Limited has informed the Exchange regarding a press release dated February 24, 2026, titled "Indoco Remedies receives final ANDA approval from USFDA for Brivaracetam Oral Solution, 10 mg/mL".
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Indoco Remedies has received final approval from the USFDA for its generic version of Brivaracetam Oral Solution (10 mg/mL), an antiepileptic drug used to treat partial-onset seizures in patients aged 1 month and older. The product is a generic equivalent to UCB Inc.'s brand Briviact. It will be manufactured at Indoco's Goa facility. The company has a turnover of US$ 180 million, 10 manufacturing facilities, and over 6,000 employees, with strong global tie-ups in generics. The MD described the approval as a significant milestone in strengthening Indoco's presence in regulated markets.
This USFDA approval opens the door for Indoco to launch and sell this generic drug in the lucrative US market, potentially boosting export revenue from regulated markets. For shareholders, this is a positive signal of the company's growing pipeline in international generics, though actual revenue impact will depend on launch timelines and market share.