Indoco Remedies Limited informed stock exchanges about receiving final approval from the USFDA for its Abbreviated New Drug Application for Lacosamide Oral Solution USP 10 mg per mL, as disclosed on January 30, 2026.
The company received final approval for its ANDA to market Lacosamide Oral Solution USP 10 mg per mL. The product is a generic equivalent of Vimpat Oral Solution 10 mg per mL, the reference listed drug of UCB Inc. The approval has been granted by the USFDA.
Lacosamide Oral Solution USP 10 mg per mL is stated to be bioequivalent and therapeutically equivalent to the reference listed drug. The medicine is used for the treatment of partial onset seizures and primary generalised tonic clonic seizures in adults and children aged at least 4 years.
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The approved product will be manufactured at Indoco Remedies Limited manufacturing facility located at L 14, Verna Industrial Area, Verna, Goa 403,722, India. The facility is part of the company’s formulation manufacturing infrastructure.
Indoco Remedies Limited is a research oriented pharmaceutical company with global operations. The company has a turnover of $180 million and an employee base of over 6,000, including more than 400 scientists and field staff.
It operates 11 manufacturing facilities, comprising 7 finished dosage form units and 4 active pharmaceutical ingredient units, with approvals from regulators including USFDA and UK MHRA.
As of January 30, 2026, at 2:36 PM, Indoco Remedies share price on NSE was trading at ₹217.12 up by 1.97% from the previous closing price.
The USFDA approval for Lacosamide Oral Solution USP 10 mg per mL marks a regulatory update disclosed under Regulation 30 of SEBI Listing Regulations. The development reflects the company’s ongoing presence in regulated pharmaceutical markets.
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Published on: Jan 30, 2026, 3:07 PM IST
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