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).
Emcure Pharmaceuticals Limited | 10/07/2025 | By Darshana | 145
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