Qilu Pharma's 33rd Formulation Product Enters U.S. Market, Reinforcing Global Recognition of Its Quality Standards

Recently, as boxes marked with "Qilu Pharma" were loaded and shipped, Qilu Pharmaceutical Group successfully completed the first commercial order shipment of Micafungin Sodium for Injection, officially sending it to the U.S. market. This is the 33rd formulation product that Qilu Pharmaceutical has exported to the United States, marking another step forward in the group's efforts to enter the high-end international market with its human pharmaceutical formulations. It fully demonstrates the strong capabilities of China’s pharmaceutical enterprises in achieving high-quality development.

Since the 1990s, Qilu Pharmaceutical has established a quality management and control system that aligns with international standards and integrates globally, implementing full lifecycle quality management for pharmaceuticals. The company consistently adheres to the concept of "quality by design," ensuring at every step—from product formulation and process screening to optimization of process parameters, determination of critical quality attributes and key process parameters, preclinical research, and clinical studies—that the design effectively guarantees high-quality production processes.

Qilu Pharmaceutical also adheres to strict quality management according to international high standards, continuously optimizing process flows. At the same time, it has consistently been "generous" in its investment in equipment and facilities for production, research and development, quality control, and information technology, placing itself at the forefront of automation, intelligence, and digitalization. It possesses some of the most superior and high-end production and testing equipment globally. Furthermore, it has designed a comprehensive management system covering the entire life cycle of pharmaceuticals, relying on experienced professionals to implement all-staff, full-scope, and whole-process quality control, ensuring that every product reaches world-class quality.

With its solid international quality, Qilu Pharmaceutical has repeatedly gained recognition from authoritative institutions both in China and abroad. It was among the first batch of companies in China to pass the new GMP certification and has also received official and authoritative certifications from the United States, the European Union, Japan, the United Kingdom, Australia, South Africa, and the World Health Organization. Qilu Pharmaceutical is the only pharmaceutical company in China that exports formulations to regulated markets in Europe, the United States, the United Kingdom, Japan, and Australia. Over 80 "Qilu standards" have been recognized as international or national reference standards, with five products listed as FDA reference standards, benefiting approximately 1.5 billion patients annually.

Editor: Zhao Jiaxin