Internationally accepted and quality assurance | Keyuan Pharma passed the US FDA certification with zero defects again!

From June 11th to 14th, Shandong Keyuan Pharmaceutical Co., Ltd. (stock code: 301281.SZ) accepted the strict audit inspection of the US Food and Drug Administration (FDA), and finally passed the certification again with zero defects, demonstrating excellent quality management strength, marking that Keyuan Pharma has taken a more solid step on the road to internationalization.

This audit inspection lasted for four days, covering four production lines and five important products, and fully covered quality system, facilities and equipment system, material system, production system, packaging and labeling system and laboratory control system. Among them, the crude methylene blue passed the FDA certification for the first time, and the API rotigotine and palonosetron hydrochloride have passed the FDA certification for three consecutive times.

During the audit process, Keyuan Pharma demonstrated a high degree of professionalism and rigorous work attitude. The whole company actively cooperated with the FDA inspectors in various inspections, not only providing detailed documentation, but also demonstrating various aspects such as production processes, equipment operation and product quality control on site. Keyuan Pharma's employees have won high praise from FDA inspectors for their professional knowledge and meticulous service.

The successful passing of the FDA audit has further enhanced Keyuan Pharma's competitiveness in the international market and demonstrated the company's highly responsible attitude towards product quality and customer health. In the increasingly fierce international competition, Keyuan Pharma has always insisted on building a market-oriented and internationally integrated quality management system, continuously improving product quality and service levels, and is committed to providing high-quality and more reliable products to global customers, injecting new impetus into the company's internationalization strategy.

With advanced production systems and quality systems, all Keyuan Pharma's products have passed the China GMP certification, and core products have passed the official pharmaceutical certifications of many countries such as the EU EDQM, the US FDA, Japan PMDA, and South Korea MFDS. Keyuan Pharma have maintained long-term and stable cooperative relations with partners in dozens of countries and regions around the world, and has a strong international reputation and influence.

Keyuan Pharma sincerely thanks FDA inspector for the professional guidance and suggestions during the audit process. In the future, Keyuan Pharma will seriously absorb these valuable suggestions and continuously optimize and improve various management work. In addition, Keyuan Pharma will take this audit as an opportunity to promote innovative R&D strength, lean management capabilities, and quality management levels to a new level, and make greater contributions to human health.