The certification was granted by the Malta Medicines Authority following an inspection of the facility, known as Plant I, conducted between November 19 and November 24, 2025. The regulator confirmed that the plant complies with the Good Manufacturing Practice requirements prescribed under the relevant European Commission directive.
Commenting on the development, Managing Director Aditi Panandikar said compliance remains a core value for the company and that the approval reinforces Indoco’s commitment to delivering high-quality healthcare products to customers globally.
The latest certification adds to a growing list of regulatory approvals secured by the drugmaker in recent months. In May, Indoco said its oral solid dosage manufacturing facility at Baddi, Himachal Pradesh, received EU GMP certification from the German Health Authority in Berlin following an inspection conducted in April. The approval confirmed compliance with European manufacturing standards and further strengthened the company’s export capabilities.
The regulatory milestone comes as Indoco works towards improving its financial performance. For the quarter ended March 2026, the company reported a net loss of ₹22 crore, compared with a loss of ₹40 crore a year earlier. Revenue rose 22% year-on-year to ₹476 crore from ₹390 crore.
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Operational performance also improved significantly. EBITDA stood at ₹50.2 crore against an EBITDA loss of ₹1 crore in the corresponding quarter last year, while EBITDA margin improved to 10.6%.
For FY26, Indoco reported revenue of ₹1,633.5 crore, up from ₹1,494.8 crore in the previous financial year. Annual EBITDA increased to ₹157.2 crore from ₹128 crore, with margins improving to 9.6%, reflecting better operating leverage and a gradual recovery in business performance.
Ahead of the announcement, shares of Indoco Remedies closed 2.6% lower at ₹231 on the NSE.
