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Emcure Pharma’s Ahmedabad facility clears US FDA inspection without observationsThe US drug regulator has completed a pre-approval inspection at Emcure’s Ahmedabad oncology facility without issuing a Form 483.By Sheersh Kapoor   July 9, 2025, 6:33:09 PM IST (Published)2 Min ReadEmcure Pharmaceuticals Ltd on Wednesday said that the United States Food and Drug Administration (US FDA) has concluded a pre-approval inspection at its oncology manufacturing facility in Ahmedabad without issuing a Form 483.

The inspection was conducted at the company’s Gujarat Industrial Development Corporation (GIDC) plant in Sanand, Ahmedabad, between June 30 and July 8.

The process ended with zero observations—a positive regulatory outcome indicating full compliance with US FDA norms.

Shares of Emcure Pharmaceuticals Ltd closed 1.09% higher at ₹1,258 on the NSE on Wednesday, ahead of the announcement.

In Q4 FY25, Emcure reported a strong set of earnings with consolidated profit after tax rising 63% year-on-year to ₹197 crore, while revenue from operations grew 19.5% to ₹2,116 crore.

Its domestic business grew 24.8% year-on-year, led by key therapeutic areas such as women’s health and cardiology. The international business rose 15.6%, with recent product acquisitions and regulatory clearances in Europe expected to support momentum.

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CEO and Managing Director Satish Mehta had noted, “Over the past year, we have effectively executed our strategies across both domestic and international markets. On the domestic side, we have expanded our covered market and built a strong product pipeline of upcoming launches.”Continue ReadingCheck out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!Tagspharma sharesshare market todayUS FDA observationsUSFDA