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News about " US FDA Inspection With Zero Observations"
Cohance Lifesciences Jaggaiahpet API Plant Clears US FDA Inspection with Zero Observations
Cohance Lifesciences has announced that its API manufacturing facility in Jaggaiahpet, Andhra Pradesh, has successfully cleared a US Food and Drug Administration current Good Manufacturing Practices (cGMP) audit with zero Form 483 observations.
US FDA Inspection With Zero Observations | 15/09/2025 | By Darshana
Emcure's Sanand Manufacturing Facility Clears US FDA Inspection With Zero Observations
The PAI, held between June 30 and July 8, 2025, is a critical regulatory step for pharmaceutical companies seeking approval to launch new products in the US. It assesses a manufacturing site’s adherence to Good Manufacturing Practices (GMP) and overall readiness to support a pending New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
US FDA Inspection With Zero Observations | 10/07/2025 | By Darshana | 144
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