Indoco Remedies Receives Final USFDA ANDA Approval for Brivaracetam Oral Solution
Indoco Remedies received final USFDA ANDA approval for Brivaracetam Oral Solution, 10 mg/mL, a generic equivalent to UCB Inc.'s Briviact. Manufactured in Goa, it treats partial-onset seizures. Ms. Aditi Panandikar highlighted this as a key milestone for expanding presence in regulated markets.
The approval of a generic drug equivalent to a reference listed drug is a positive step for Indoco Remedies, potentially increasing its revenue from the US market. However, the impact is considered medium as the specific financial projections or market share are not detailed.
The USFDA approval of the ANDA for Brivaracetam Oral Solution is a positive development for Indoco Remedies, indicating successful product development and regulatory compliance, which is expected to strengthen its market presence.
Indoco Remedies Limited has received the final approval of its Abbreviated New Drug Application (ANDA) from the USFDA for Brivaracetam Oral Solution, 10 mg/mL. This product is a generic equivalent to Briviact 10 mg/mL, manufactured by UCB, Inc.
The Brivaracetam Oral Solution has been confirmed to be bioequivalent and therapeutically equivalent to the reference listed drug. The manufacturing will take place at Indoco Remedies' facility in Verna, Goa. This antiepileptic drug is prescribed for the treatment of partial-onset seizures in patients aged one month and older.
Ms. Aditi Panandikar, Managing Director, stated that the ANDA approval is a significant milestone, reinforcing Indoco's presence in regulated markets and its commitment to providing innovative and affordable healthcare globally. The company has a global turnover of US$ 180 million and employs over 6000 people, including more than 400 scientists.
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Indoco Remedies Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it medium impact: worth reading, rarely worth acting on by itself.
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See the model portfoliosA plain-language summary of a public exchange filing by Indoco Remedies Limited. Read the original for the full detail.