Shares of Indoco Remedies Ltd gained as much as 7% following the company's announcement of final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution, 10 mg/mL. According to reports from CNBC TV18, the approval allows the company to market a generic equivalent of Briviact 10 mg/mL, the reference listed drug of UCB, Inc., in the United States market. The company confirmed that Brivaracetam Oral Solution, 10 mg/mL, has been determined to be bioequivalent and therapeutically equivalent to the reference product.
As reported by CNBC TV18, the company's 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 L-14, Verna Industrial Area, Verna, Goa – 403722, which has regulatory approvals for exports to regulated markets. This manufacturing facility is specifically located in the Verna Industrial Area, Goa, where the company maintains its regulatory-compliant operations.
According to CNBC TV18, Managing Director Aditi Panandikar commented on the development, stating that the ANDA approval for Brivaracetam is a significant milestone as the company continues to strengthen its presence in regulated markets. Panandikar emphasized the company's commitment to offering innovative and affordable healthcare to patients worldwide, highlighting the strategic importance of this regulatory approval for their international operations.
For the December quarter, as reported by CNBC TV18, 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. However, the company's revenue increased 8.5% year-on-year to ₹445.4 crore from ₹410.6 crore. EBITDA nearly tripled to ₹31.5 crore from ₹12 crore in the year-ago quarter, and EBITDA margin expanded to 7.1% from 2.9%.
According to CNBC TV18, 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, indicating recent volatility despite the positive regulatory development. The latest market response demonstrates continued investor confidence in the company's regulatory achievements and strategic focus on regulated markets.
