Views: 0 Author: Site Editor Publish Time: 2025-04-11 Origin: Site
——International Quality System Earns Renewed Global Recognition
Recently, a leading API manufacturer in Southwest China successfully underwent a 5-day GMP audit conducted by the European Medicines Agency (EMA). The inspection covered critical active pharmaceutical ingredients including Ampicillin Sodium, Sulbactam Sodium, and their compound formulations, reaffirming the company's compliance
with stringent international quality standards.
An expert team led by Norwegian regulatory auditors conducted comprehensive evaluations through on-site verification, personnel interviews, and data integrity assessments. The audit report particularly commended the company's pioneering practices in "real-time risk control mechanisms" and "low-carbon production technologies", establishing new benchmarks for sustainable pharmaceutical manufacturing.
Notably, this marks the company's third successful EU GMP renewal with zero critical findings since its initial certification in 2019. The manufacturer has established a multi-regulatory compliance system covering China NMPA, Japan PMDA, and WHO-PQ requirements, with its APIs currently approved for use in over 40 countries worldwide, providing essential supply chain support to global pharmaceutical partners.
With an upcoming FDA inspection scheduled in March, the company is accelerating its global expansion strategy. Industry analysts emphasize that the sustained success of China's GMP-certified API producers is reshaping international supply chain dynamics, offering diversified procurement solutions while enhancing China's strategic role in the global pharmaceutical ecosystem.
