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USFDA issues four minor observations to JB Chemicals’ Gujarat facility

USFDA issues four minor observations to JB Chemicals’ Gujarat facility

US Food and Drug Administration (USFDA) has issued four minor observations to JB Chemicals & Pharmaceuticals’ solid oral manufacturing facility at Panoli, Gujarat. The company proposes to address these observations within next 15 days. These observations will not have any impact on the current business and will facilitate ANDA of capsule product that is already filed.

The company went through a USFDA pre-approval inspection (PAI) for ANDA filed for a capsule product. The said inspection was carried out from October 15-18, 2018 at the company’s solid oral manufacturing facility at Panoli.

JB Chemicals & Pharmaceuticals is engaged in manufacturing of pharmaceutical specialties in various dosage forms, herbal remedies, diagnostics, generic drugs, active pharmaceutical ingredients (APIs).