Indoco Remedies Ltd., a fully integrated, research-oriented pharmaceutical company, has received the US FDA final approval of its Abbreviated New Drug Application (ANDA) for brivaracetam oral solution, 10 mg/mL, to market, a generic equivalent to the reference listed drug (RLD), Briviact 10 mg/mL, of UCB, Inc.
Brivaracetam oral solution, 10 mg/mL, has been determined to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Briviact 10 mg/mL of UCB, Inc.
Brivaracetam oral solution will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.
Brivaracetam oral solution (10 mg/mL) is a prescription antiepileptic drug (anticonvulsant) used for treatment of partial-onset seizures in patients 1 month of age and older.
Commenting on the achievement, Aditi Panandikar, managing director said, “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.”
Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence. The company’s turnover is US$ 180 million with a human capital of over 6000 employees, including over 400 skilled scientists and field staff who are the strength of the organization.
The company has 10 manufacturing facilities, 6 for FDFs and 4 for APIs, supported by a state-of-the-art R&D centre and a CRO facility. The facilities have been approved by most of the regulatory authorities including US FDA and UK-MHRA. |