GUFICBIO : USFDA ISSUES 3 FORM 483 OBSERVATIONS AT INDORE FACILITY

• USFDA conducted a Pre-Approval Inspection at the company's manufacturing facility at Plot no. 48, Smart Industrial Park, Pithampur, District Dhar, Indore, Madhya Pradesh • Inspection period was October 15, 2026 to October 23, 2026 • Company received 3 observations in Form FDA 483 upon conclusion of the inspection • Company said it will work closely with the USFDA and address the observations comprehensively within the stipulated timeframe

Gufic Biosciences Ltd

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