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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.
Continuously advancing internationalization | Keyuan Pharmaceutical establishes a dedicated task force to prepare for the FDA certification inspection!
Publish Time:
2024-04-28
Recently, Shandong Keyuan Pharmaceutical Co., Ltd. (stock code: 301281.SZ) established a dedicated task force to prepare for the certification inspection by the U.S. Food and Drug Administration (FDA). Led by President Wang Jianwei, the team includes key executives from relevant departments who have collectively developed a comprehensive and detailed action plan, ensuring that every aspect of the certification preparation is thoroughly and meticulously executed.
Recently, Shandong Keyuan Pharmaceutical Co., Ltd. (stock code: 301281.SZ) established a dedicated task force to prepare for the certification inspection by the U.S. Food and Drug Administration (FDA). Led by President Wang Jianwei, the team includes key personnel from relevant departments who have jointly developed a comprehensive and detailed action plan, ensuring that every aspect of the certification preparation is thoroughly and meticulously executed.
The FDA is an internationally recognized authority in medical auditing, authorized by the U.S. Congress—acting as the federal government—to specialize in the management of food and drug quality and safety. Today, products such as foods, pharmaceuticals, cosmetics, and medical devices that have received FDA certification are globally acknowledged as effective and safe for human use, serving as the highest global standard of proof for product quality and efficacy.
Previous year's FDA certificate
Keyuan Pharmaceutical is a leading enterprise in China's specialized chemical API sector, having earned continuous, multi-year official FDA certification. Its core products have also successively obtained official regulatory approvals from authorities in multiple countries, including the EU’s EDQM, Japan’s PMDA, and South Korea’s KFDA. With cutting-edge R&D capabilities, advanced digital and intelligent manufacturing prowess, and consistently high product quality, the company maintains long-term, stable partnerships with collaborators across dozens of nations and regions worldwide, enjoying strong international recognition and influence.
Facing an increasingly complex international market competition landscape, Keyuan Pharmaceutical is adopting a development strategy of "One Core, Two Wings, Three Pillars," firmly focusing on the chronic disease sector while expanding into other specialized niche markets. The company continues to strengthen its core advantages in integrated raw material and formulation capabilities, as well as integrated excipient and formulation solutions. At the same time, it is enhancing technology R&D, advancing digital and intelligent manufacturing, and promoting cultural marketing—all while staying true to its enduring commitment of "Healthy China, Caring for Every Promise"—to build a leading, innovative, and digitally-driven pharmaceutical brand in China.
Digital and Intelligent Pharmaceuticals: Global Expansion
The company will take this FDA inspection as an opportunity to further enhance its innovative R&D capabilities, lean management expertise, and quality management standards, accelerating its globalization efforts to capture a larger share of the international market—and continue contributing Keway's strength toward the high-quality development of the global healthcare industry!
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