Indoco Remedies Gets US FDA Approval for Brivaracetam Oral Solution

The US FDA has approved the final approval of brivaracetam oral solution, 10 mg/mL, which is a generic version of the Briviact 10 mg /mL of UCB, Inc. The license allows Indoco to sell brivaracetam oral solution in America.

Brivaracetam oral solution is a type of anticonvulsant utilized in treating partial-onset seizures amongst patients as young as 1 month of age. It was established that it is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), which is Briviact 10 mg/mL. The product will be produced in the state-of-the-art plant of Indico Remedies in Verna, Goa, India.

Aditi Panandikar, Managing Director of Indoco Remedies, commented, “The ANDA approval for brivaracetam is a significant milestone for us as we continue to strengthen our presence in the regulated markets. We are committed to offering innovative and affordable healthcare to patients worldwide.”

Also Read: The Future of MedTech in India: Meeting Tier-2 and Tier-3 Needs

Indoco Remedies is a fully integrated, research-based, pharmaceutical firm that is globally based. The company employs over 6000 people, including 400 hardened scientists, with a turnover of USD 180 million.

Indico has 10 manufacturing plants, six Finished Dosage Forms(FDFs) plants, and four Active Pharmaceutical Ingredients(APIs) plants, which are approved by regulatory agencies such as the US FDA and UK-MHRA.