Indoco Remedies Receives USFDA Approval for Lacosamide Oral Solution ANDA

Lacosamide Oral Solution is indicated for the treatment of partial-onset seizures and primary generalized tonic-clonic seizures in adults and paediatric patients aged four years and above suffering from epilepsy.

Commenting on the development, Aditi Panandikar, Managing Director, Indoco Remedies Ltd., said, “We are excited about the ANDA approval for Lacosamide Oral Solution USP, 10 mg/mL. This approval further reinforces our commitment to delivering high-quality healthcare to patients worldwide.”

The approval strengthens Indoco’s presence in the US generics market, particularly in the neurology segment, and follows recent regulatory progress for the company’s manufacturing facilities.

Indoco Remedies is a fully integrated, research-oriented pharmaceutical company with a global footprint. The company operates 11 manufacturing facilities, including seven finished dosage form units and four API plants, supported by a state-of-the-art R&D centre and a contract research organisation. Its facilities are approved by major global regulators, including the USFDA and UK-MHRA.