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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.
Quality Culture
Quality Philosophy: Quality is self-esteem, quality is life
Quality Policy: Quality first, reputation first, service integrity, pursuit of excellence
Quality Strategy: Establish a market-oriented quality management system in line with international standards
Quality Principles: Quality originates from design, do it right the first time, zero defects, PDCA cycle, full life cycle
Quality Management Model
One Standard: Determine the conformity target of product quality
Two Audits: Audit the internal quality management system and audit the supplier management system
Three Determinations: Determine product quality standards, determine material quality standards, determine intermediate quality standards
Four Supervisions: Supervise the consistency of process procedures and registered processes, supervise the consistency of production operations and process procedures, supervise the consistency of production operations and SOPs, supervise the consistency of paper records and electronic records
Five Handlings: Customer complaint handling, change handling, deviation handling, CAPA handling, return and exchange handling
Six Evaluations: Quality system evaluation, product quality evaluation, supplier system evaluation, equipment and facilities system evaluation, material system evaluation, factory system evaluation
Domestic GMP certification
Koyuan Pharmaceutical & Linoa Pharmaceutical strictly follow GMP standards. Their product lines, including raw materials, tablets, capsules, sprays, and pastes, have all successfully passed GMP certification, demonstrating the quality of the domestic pharmaceutical industry.
US FDA certified
In June 2024, Linyi Pharmaceutical passed the stringent US FDA review again with zero defects. Among them, methylene blue crude product was certified for the first time, and Rotecoting and Palonosetron Hydrochloride APIs won the FDA for the third time, demonstrating the company's continuously improving international competitiveness and product quality.
MFDS certification in South Korea
Since 2005, Keyuan Pharmaceutical has established its market foundation by being the first to obtain MFDS certification in Korea for its Gliclazide product. In 2014, Metformin Hydrochloride also received certification, further strengthening the company's competitive advantage in the Korean market and demonstrating its strong quality control capabilities.
EU CEP certification
Since 2006, Kexuan Pharmaceutical's star products, such as gliclazide, isosorbide mononitrate, and metformin hydrochloride, have successively passed the CEP certification issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM), opening up the company's European market and starting a new chapter of internationalization.
HC Certification in Canada
In 2018, Keyuan Pharmaceutical successfully passed a rigorous 5-day quality audit by Health Canada and obtained HC certification. This certification laid a solid foundation for subsequent US FDA certification, EU certification, and improvement of the company's quality management system.
Japanese PMDA certification
In 2019, Keyuan Pharmaceutical's isosorbide mononitrate lactose blend raw material received PMDA certification in Japan. This honor not only represents high recognition of the product's superior quality, safety, and efficacy, but also lays a solid foundation for the company's entry into the Japanese market.
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Seven major quality management systems, in line with international standards Quality First: We pursue the highest quality in pharmaceuticals throughout the entire product lifecycle. |
Address: No. 26, Keyuan Street, Shanghe County, Jinan City, Shandong Province
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