India Pharma Outlook Team | Tuesday, 03 February 2026
Indoco Remedies has secured Indoco Remedies USFDA approval for its Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution, marking a key regulatory win for the Indian pharmaceutical company.
This approval is a significant regulatory achievement for the company, as it enables Indoco to market a generic version of the UCB Inc. product called Vimpat Oral Solution in the United States and expand its presence in regulated markets.
The newly approved product is both bioequivalent and therapeutically equivalent to the reference listed drug. It will be manufactured at Indoco's plant located at the Verna Industrial Area of Goa, which manufactures and supplies many products to a number of different international markets. This approval will help accelerate growth through Indoco's U.S. portfolio and continued focus on quality led growth.
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Lacosamide Oral Solution is indicated for the treatment of partial onset seizures in addition to primary generalized tonic clonic seizures. It can be used in both adults and children over 4 years, which represents a significant unmet need for those with epilepsy due to its ease of utilization via an oral dosage form.
Commenting on the development, Aditi Panandikar, Managing Director, 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.”
With this Indoco Remedies USFDA Approval, the company continues to gain market share and build its scale in the U.S. generic pharmaceutical market. The approval also highlights Indoco’s regulatory capabilities and its ability to meet stringent U.S. manufacturing and compliance standards, supporting its long-term expansion strategy.
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