Indoco Remedies Limited has informed the Exchange regarding a press release dated January 30, 2026, titled "Indoco Remedies receives final ANDA approval from USFDA for Lacosamide Oral Solution USP,10mg/mL".
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Awaiting price reaction for this filing.
Indoco Remedies has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution USP, 10mg/mL. Lacosamide is a generic version used in the treatment of epilepsy and seizures. With this approval, the company is now eligible to manufacture and market this product in the United States. This adds to Indoco's portfolio of US-approved generic products and strengthens its regulated markets pipeline. The product is expected to contribute to the company's US formulation revenues, though the scale of impact will depend on market dynamics and competition.
Positive for shareholders — opens a new revenue stream from US generic sales, though actual financial impact depends on market share capture and pricing competition in the US generics space.