At the conclusion of the inspection, the company received a Form 483 with seven observations. The company said the observations are procedural in nature.
Emcure Pharmaceuticals added that it is addressing the observations comprehensively and will respond to the US FDA within the stipulated timeframe. The inspected facility is located at G.I.D.C., Taluka-Sanand, Ahmedabad, Gujarat.
Also Read: Emcure Pharma Q2 | Profit rises 25% to ₹243 crore, revenue up 13% YoYWhat is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors after the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
Post Form 483 is issued, the company is given 15 days to submit its response to the USFDA explaining what steps the company will take to resolve the observations made by the USFDA.
Fourth Quarter Results
Net profit for the quarter rose 29% year-on-year to ₹243 crore from ₹189 crore. Revenue increased 16.7% to ₹2,469.7 crore compared to ₹2,116.2 crore in the year-ago period, reflecting healthy traction across key markets. EBITDA grew 19.2% to ₹479.5 crore, while margins improved marginally to 19.4% from 19% a year earlier.
Also Read: Emcure Pharma Q3 Results: Strong operating performance but stock gives up gains
The company’s international business remained the key growth driver, with sales rising 25.7% YoY to ₹1,493 crore, supported by base business ramp-up and new product launches. Domestic sales came in at ₹977 crore, up 5.2% YoY, impacted by softer performance in the Zuventus portfolio and organisational restructuring.
On Friday (May 15), shares of Emcure Pharmaceuticals Ltd ended at ₹1,702.30, up by ₹28.90, or 1.73%, on the BSE.
(Edited by : Jomy Jos Pullokaran)
First Published: May 16, 2026 3:55 PM IST
