The USFDA inspected the company’s Plant II (Sterile) facility in Goa from August 27 to September 4, 2026. At the conclusion of the inspection, the company received seven observations in Form 483.
Indoco Remedies said it is addressing the observations comprehensively and will submit its response to the USFDA within the stipulated timeframe.
Form 483 observations are issued by the USFDA when its investigators identify conditions that may constitute violations of regulatory requirements during an inspection. The observations do not represent a final regulatory determination.
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Indoco Q1 results
Indoco Remedies reported an improvement in its June quarter performance, returning to a net profit of ₹65 crore, compared to a net loss of ₹36 crore in the year-ago quarter. Revenue from operations rose 6.4% year-on-year to ₹467 crore from ₹439 crore in Q1FY26.Operating performance also improved, with Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) rising to ₹40.8 crore from ₹16.7 crore a year earlier. EBITDA margin expanded to 8.7% from 3.8% in the corresponding quarter last year.
After falling as much as 5.5% to an intraday low of ₹248.06 on Monday, shares of Indoco Remedies are now trading 3.1% lower at ₹254.49. The stock has risen 15% over the last one month, thereby turning positive on a year-to-date basis as well.
