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Contact UsThe company focuses on the research, development, production, and sales of chemical raw materials and their formulations. All products have passed national GMP certification, and core products have successively passed official pharmaceutical regulatory certifications from multiple countries, including the EU EDQM, US FDA, Japanese PMDA, and South Korean MFDS. Following its successful listing on the Shenzhen Stock Exchange's ChiNext board on April 4, 2023, Keyuan Pharmaceutical has entered a phase of rapid development driven by both digital intelligence and capital, with its business spanning dozens of countries and regions worldwide.
Internationally recognized quality assurance | Keyuan Pharmaceutical achieves zero-defect status once again with U.S. FDA certification!
Publish Time:
2024-06-18
FDA stands for the U.S. Food and Drug Administration, an agency authorized by the U.S. Congress—acting as the federal government—to specifically oversee the quality and safety management of food and pharmaceutical products. Today, products such as food, drugs, cosmetics, and medical devices that have been certified by the FDA are globally recognized as effective and safe for human use, serving as a world-class benchmark for product quality and efficacy.
FDA stands for the U.S. Food and Drug Administration, an agency authorized by the U.S. Congress—acting as the federal government—to specifically oversee the safety and quality management of food and pharmaceutical products. Today, products such as food, drugs, cosmetics, and medical devices that have received FDA approval are globally recognized as effective and safe for human use, serving as a universal benchmark of high-quality standards and proven efficacy worldwide.
From June 11 to 14, Shandong Keyuan Pharmaceutical Co., Ltd. (stock code: 301281.SZ) underwent a rigorous audit inspection by the U.S. Food and Drug Administration (FDA), ultimately achieving certification once again with zero deficiencies. This milestone underscores the company’s exceptional quality management capabilities and marks a more solid step forward for Keyuan Pharmaceutical on its journey toward global expansion.
This four-day audit inspection covered four production lines and five key products, providing a comprehensive review of the company’s quality system, facility and equipment systems, material management system, production system, packaging and labeling system, as well as laboratory control processes. Notably, crude methylene blue successfully obtained certification for the first time, while the active pharmaceutical ingredients rotigotine and palonosetron hydrochloride earned FDA approval for the third time—following their previous certifications in 2015 and 2018, respectively.
During the audit process, Keyuan Pharmaceutical demonstrated a high level of professionalism and a meticulous work attitude. The company actively cooperated with the FDA inspectors in all aspects of the inspection, providing not only comprehensive documentation but also showcasing on-site the entire production process, equipment operations, and quality control measures. Keyuan Pharmaceutical's employees earned high praise from the FDA inspectors for their expert knowledge and attentive service.
Audit Site
This successful FDA audit further strengthens Keyuan Pharmaceutical's competitiveness in the international market, demonstrating the company's unwavering commitment to product quality and public health. In an increasingly fierce global marketplace, Keyuan Pharmaceutical remains steadfastly dedicated to building a market-driven quality management system that aligns with international standards, continuously enhancing both product quality and service excellence. We are committed to delivering high-quality, more reliable products to customers worldwide, injecting fresh momentum into the company’s global expansion strategy.
Leveraging its advanced production and quality systems, Keyuan Pharmaceutical has ensured that all its products have achieved national GMP certification. Moreover, its core products have successively obtained official pharmaceutical regulatory approvals from multiple international authorities, including the EU's EDQM, the U.S. FDA, Japan's PMDA, and South Korea's MFDS. As a result, Keyuan Pharmaceutical maintains long-term, stable partnerships with collaborators across dozens of countries and regions worldwide, solidifying its strong global recognition and influence.
Global Deployment
Keyuan Pharmaceutical sincerely thanks the FDA inspectors for their professional guidance and valuable advice throughout the audit process. Moving forward, we will carefully incorporate these insightful recommendations to continuously refine and enhance our management practices. Taking this audit as an opportunity, the company will further strengthen its innovation-driven R&D capabilities, streamline operational efficiency, and elevate its quality management standards—paving the way for even greater contributions to the global health community.
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