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USFDA completes pre-approval inspection at Gufic Biosciences’ Indore facility

24 Oct 2026 Evaluate

United States Food and Drug Administration (USFDA) completed a pre-approval inspection at Gufic Biosciences’ manufacturing facility located at Smart Industrial Park, Near Natrip, Pithampur, District Dhar, Indore, Madhya Pradesh. The inspection was conducted from October 15, 2026 to October 23, 2026.

Upon conclusion of the inspection, the company received 3 observations in Form FDA 483. The company will work closely with the USFDA and remains committed to addressing the observations comprehensively within the stipulated timeframe. 

Gufic Biosciences is engaged in diversified business viz. Pharma, Healthcare, Bio- Technology, Seeds, Herbal etc. 


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