News about "current Good Manufacturing Practices (cGMP) "

Cohance's Jaggaiahpet API Plant Clears USFDA Inspection with Zero 483 Observations

Cohance's Jaggaiahpet API Plant Clears USFDA Inspection with Zero 483 Observations

The United States Food and Drug Administration (USFDA) has completed a general current Good Manufacturing Practices (cGMP) audit at Cohance Lifesciences' API manufacturing facility (API Unit1) located at Jaggaiahpet, Andhra Pradesh, with zero Form 483 observations.

Current Good Manufacturing Practices (cGMP) | 12/09/2025 | By Dineshwori 210

Sun Pharma Halol Facility Classified OAI by US FDA, Shipments Restricted

Sun Pharma Halol Facility Classified OAI by US FDA, Shipments Restricted

The US Food and Drug Administration (FDA) has classified Sun Pharma's Halol facility as “Official Action Indicated” (OAI) following an inspection conducted between June 2 and June 13, 2025.

Current Good Manufacturing Practices (cGMP) | 10/09/2025 | By Dineshwori 411

Lupin's Aurangabad Facility Gets Two Observations After US FDA Inspection

Lupin's Aurangabad Facility Gets Two Observations After US FDA Inspection

The United States Food and Drug Administration (US FDA) has completed a product-specific pre-approval inspection at Lupin’s Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility, issuing two observations.

Current Good Manufacturing Practices (cGMP) | 06/09/2025 | By Dineshwori 186


 

 

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