Indoco Remedies testing unit clears FDA pre-approval inspection with zero observations

Pharma firm Indoco Remedies Ltd on Monday (April 13) said its testing facility in Chhatrapati Sambhaji Nagar (Aurangabad), Maharashtra, has completed a US FDA pre-approval inspection with zero Form 483 observations.The company said the inspection was conducted by the US Food and Drug Administration between April 8-10, 2026.

In February this year, Indoco Remedies said the Maharashtra State Goods & Services Tax (GST) Department concluded its inspection/search on February 8 at 8.15 pm.

The inspection was conducted under the Maharashtra Goods & Services Tax Act, 2017. The company submitted all requested documents, clarifications, and details, and no official notice or document has been issued by the authority.”…we hereby notify that the Goods & Service Tax Department, Maharashtra have concluded their Inspection/Search on 08th February, 2026,” according to a stock exchange filing. The company stated that the inspection/search has no material impact on its financials, operations, or other activities.

Third quarter results

Indoco Remedies Ltd reported a wider net loss for the December quarter. The company posted a net loss of ₹29.8 crore for the quarter, compared with a loss of ₹26.4 crore in the corresponding period last year.

Revenue rose 8.5% year-on-year to ₹445.4 crore from ₹410.6 crore. Operating performance strengthened, with EBITDA coming in at ₹31.5 crore, nearly tripling from ₹12 crore a year ago. EBITDA margins expanded to 7.1% from 2.9% in the year-ago quarter.

Shares of Indoco Remedies Ltd ended at ₹209.95, up by ₹7.80, or 3.86%, on the BSE today, April 13.