Indoco Remedies shares rise 7% on USFDA approval for Brivaracetam oral solution

Shares of Indoco Remedies Ltd gained as much as 7% after the company received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution, 10 mg/mL.In a press release filed with the exchanges on Tuesday, February 24, Indoco said the approval allows it to market a generic equivalent of Briviact 10 mg/mL, the reference listed drug of UCB, Inc., in the United States.

The company said its Brivaracetam Oral Solution has been determined to be bioequivalent and therapeutically equivalent to the reference product. The drug is a prescription antiepileptic medication used for the treatment of partial-onset seizures in patients aged one month and older.
The product will be manufactured at Indoco’s facility in Verna Industrial Area, Goa, which has regulatory approvals for exports to regulated markets.
Commenting on the development, Managing Director Aditi Panandikar 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 Remedies operates 10 manufacturing facilities, including six for finished dosage forms and four for active pharmaceutical ingredients, and has a presence across domestic and international markets.

For the December quarter, the pharma company reported a net loss of ₹29.8 crore, compared with a loss of ₹26.4 crore in the corresponding period last year.

Its revenue increased 8.5% year-on-year to ₹445.4 crore from ₹410.6 crore. EBITDA, however, nearly tripled to ₹31.5 crore from ₹12 crore in the year-ago quarter, and EBITDA margin expanded to 7.1% from 2.9%.

Shares of the company rose following the announcement and were trading 4.76% up at ₹209.33 as of 12.02 pm. The stock has declined 25.99% in the past six months.