Indoco Remedies shares surged more than 16% in intraday trade on Thursday, snapping a five-day losing streak after the company announced successful completion of UK MHRA cGMP inspection at its Goa manufacturing facility. The stock opened 13% higher at ₹234.94 and extended gains to hit an intraday high of ₹269.90 on the NSE. As of 3 PM, the stock was trading 11% higher at ₹256.20, holding on to most of the day's gains. The positive regulatory development was accompanied by a spurt in trading volume, which was more than 3.57 times the average, significantly outperforming the benchmark BSE Sensex which traded 0.21% lower at 74,609. The stock movement reflects strong market confidence in the company's regulatory compliance across multiple jurisdictions.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) conducted a cGMP inspection of Indoco Remedies' Plant I facility in Goa from September 7 to 9, 2026. According to an exchange filing, the inspection of the facility, which manufactures solid oral dosage forms, concluded with no critical or major observations, indicating full compliance with the regulator's applicable manufacturing standards. This positive outcome provides additional regulatory validation for the company's manufacturing capabilities and quality systems. The facility caters to regulated markets including the UK, Europe, South Africa, New Zealand, Australia and Canada, and is expected to contribute around 30% of the company's total international business. As per Business Standard, Managing Director Aditi Panandikar commented that "This plant has been consistently catering to the regulated markets of the UK, Europe, South Africa, New Zealand, Australia and Canada for several years and is expected to contribute to approx. 30% of total international business. The successful completion of the UKMHRA cGMP inspection with no critical or major observations is a strong validation of our robust quality systems."
Just three days ago, Indoco Remedies received seven observations in Form 483 from the United States Food and Drug Administration (USFDA), which inspected its manufacturing facility at Plant II (Sterile) in Goa from August 27 to September 4. According to Business Standard, the company had faced a regulatory setback earlier this week when the USFDA issued seven observations in Form 483 following the inspection of Indoco's Plant II (Sterile) facility. The company said it is addressing the observations comprehensively and will submit its response within the stipulated timeframe. This latest UK MHRA clearance provides significant relief after the recent USFDA setback, demonstrating the company's ability to maintain regulatory compliance across different jurisdictions.
The facility has secured comprehensive regulatory approvals across multiple international markets. According to Business Standard, the Plant I facility in Goa is approved by USFDA for solid dosages, creams and capsules, TGA-Australia for solid dosages, liquid orals, creams and ointments, and EU Malta's MMA for solid dosages. The facility also holds WHO-GMP approval and has successfully faced audit by SAHPRA for solid dosages. Additionally, the facility manufactures solid oral dosage forms and liquid dosage forms, expanding its regulatory compliance beyond the UK MHRA approval. The company's diversified regulatory approvals across multiple markets provide multiple revenue streams and reduce dependence on any single jurisdiction.
Today is also the ex-date for a final dividend for FY2026. Back in May, the company's board, along with the Q4FY26 results, had recommended a dividend of ₹0.20 per equity share on a face value of ₹2 for the financial year 2025-2026. Indoco Remedies is engaged in the manufacturing and marketing of pharmaceutical Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs). The company's strong financial recovery in Q1 FY27 with consolidated net profit of ₹65 crore compared to a net loss of ₹36 crore in the year-ago quarter, demonstrates its operational turnaround capabilities despite recent regulatory challenges.
