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The approval allows the company to market a generic version of Briviact 10 mg/mL oral solution, the reference listed drug (RLD) of UCB, Inc.
The company said its Brivaracetam Oral Solution has been determined to be bioequivalent and therapeutically equivalent to the RLD.
The product will be manufactured at Indoco Remedies’ facility located at L-14, Verna Industrial Area, Verna, Goa – 403722, India.
Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug indicated for the treatment of partial-onset seizures in patients aged one month and older.
Aditi Panandikar, managing director (MD) 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 is engaged in the manufacturing and marketing of Formulations and Active Pharmaceutical Ingredients. The Company caters to both Domestic and International markets.
The company’s consolidated net loss of Rs 23.64 crore in Q3 FY26 as against net loss of Rs 27.30 crore in Q3 FY25. Revenue from operations rose 7.9% year on year to Rs 434.34 crore in Q3 FY26.
Indoco Remedies announced final approval of the Company's Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution USP, 10 mg/mL, to market, a generic equivalent to the reference listed drug (RLD), Vimpat Oral Solution, 10 mg/mL, of UCB, Inc. (UCB), from USFDA.
Lacosamide Oral Solution USP, 10 mg/mL, is bioequivalent and therapeutically equivalent to the reference listed drug, Vimpat Oral Solution, 10 mg/mL, of UCB, Inc. (UCB).
Lacosamide Oral Solution USP, will be manufactured by Indoco Remedies, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.
Lacosamide Oral solution is used to treat partial onset seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy who are at least 4 years old.
Realty shares tumbled for second consecutive trading session.
At 14:25 IST, the barometer index, the S&P BSE Sensex declined 47.59 points or 0.06% to 83,419.87. The Nifty 50 index fell 62.95 points or 0.25% to 25,534.40.
The broader market underperformed the frontline indices. The S&P BSE Mid-Cap index declined 1.33% and the S&P BSE Small-Cap index fell 0.47%.
The market breadth was weak. On the BSE, 1,188 shares rose and 2,960 shares fell. A total of 167 shares were unchanged.
Economy:
The seasonally adjusted HSBC India Services PMI Business Activity Index stood at 58.9 in October, comfortably above both the neutral mark of 50.0 and its long-run average of 54.3. October data showed softer, although still substantial, expansions in Indian services output and new business. While factors like demand buoyancy and GST (Goods and Services Tax) relief reportedly led to an improvement in operating conditions, competition and heavy rains constrained growth.
HSBC India Composite PMI Output Index fell to 60.4 in October from 61.0 in September. There was also a weaker, albeit still substantial, upturn in aggregate sales. The rate of expansion was the softest in five months. For new orders and output, the slowdowns in growth were centred on the service economy as manufacturers actually registered quicker rates of expansion.
Buzzing Index:
The Nifty Realty index fell 1.27% to 948.85. The index dropped 2.04% in the two consecutive trading sessions.
Anant Raj (down 3.49%), Godrej Properties (down 3.45%), Brigade Enterprises (down 2.46%), DLF (down 2.03%), Prestige Estates Projects (down 1.31%), Phoenix Mills (down 1.24%) and Oberoi Realty (down 0.02%) declined.
Numbers to Track:
The yield on India's 10-year benchmark federal paper shed 0.47% to 6.499 from the previous close of 6.530.
In the foreign exchange market, the rupee edged higher against the dollar. The partially convertible rupee was hovering at 88.6400 compared with its close of 88.7700 during the previous trading session.
MCX Gold futures for 5 December 2025 settlement rose 0.71% to Rs 121,376.
The US Dollar Index (DXY), which tracks the greenback's value against a basket of currencies, was down 0.15% to 100.02.
The United States 10-year bond yield fell 0.38% to 4.143.
In the commodities market, Brent crude for December 2025 settlement advanced 34 cents or 0.54% to $63.86 a barrel.
Stocks in Spotlight:
Devyani International (DIL) declined 2.105 after the company reported a mixed Q2 FY26 performance, with net loss widening to Rs 23.95 crore from Rs 4.92 crore in Q2 FY25, despite revenue growth driven by network expansion and steady demand. On a consolidated basis, revenue from operations increased 12.7% year-on-year to Rs 1,376.75 crore in the quarter ended September 2025.
Indoco Remedies fell 1.70%. The company consolidated net loss narrowed to Rs 9.21 crore in Q2 FY26, compared with net loss of Rs 10.01 crore reported in Q2 FY25. Revenue from operations stood at Rs 471.83 crore in the second quarter of FY26, up 9.59% as against Rs 430.66 crore posted in Q2 FY25.
Piramal Pharma rose 0.92%, The company reported a consolidated net loss of Rs 99.22 crore in Q2 FY26, compared with a net profit of Rs 22.59 crore recorded in Q2 FY25. Revenue from operations for the period under review declined 8.83% year-on-year (YoY) to Rs 2,043.72 crore. The YoY performance was impacted by inventory destocking by a customer in one large CDMO order.
Revenue from operations stood at Rs 471.83 crore in the second quarter of FY26, up 9.59% as against Rs 430.66 crore posted in Q2 FY25.
The company reported a pre-tax loss of Rs 13.35 crore in Q2 FY26, compared with a pre-tax loss of Rs 4.84 crore in Q2 FY25. The firm also recorded exceptional items amounting to Rs 0.53 crore during the quarter.
EBITDA for the quarter stood at Rs 53.4 crore, compared with Rs 52.9 crore in the corresponding quarter of the previous year.
Aditi Panandikar, MD, Indoco Remedies, said, “International formulation and API businesses had a good growth this quarter. The India formulation business performance was impacted due to revision in the GST rates. We are confident of regaining momentum in the coming quarters.
Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence. The Company’s turnover is US$ 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.
Shares of Indoco Remedies fell 1.72% to currently trade at Rs 268.50 on the BSE.