SHANGHAI, CHINA – June 4, 2025 — Medicilon Preclinical Research (Shanghai) LLC (“Medicilon”), a leading provider of preclinical R&D services, today announced that it has successfully completed a comprehensive inspection by the U.S. Food and Drug Administration (FDA) and received a positive Establishment Inspection Report (EIR), affirming its position as a trusted global partner in drug development.
This rigorous FDA inspection—the first in seven years—evaluated Medicilon’s full compliance with international standards across:
FDA inspectors commended Medicilon for its “scientific discipline” and “high standards of workmanship,” expressing confidence in the quality of future data submissions. The EIR reflects Medicilon’s steadfast commitment to its core philosophy: “Quality First.”
“This inspection outcome is a major milestone for Medicilon. It affirms the rigor, consistency, and transparency that we apply to every aspect of our preclinical work. We are proud to be recognized by the FDA and remain committed to enabling innovative global drug development with world-class quality.”
By the end of 2024, Medicilon had successfully supported the submission of 520 Investigational New Drug (IND) applications across key global markets, including:
Medicilon’s diverse IND portfolio includes:
This broad innovation footprint reflects Medicilon’s strategic vision: growth through innovation with a focus on quality.
Founded in 2004, Shanghai Medicilon Inc. (Stock Code: 688202.SH) is a contract research organization (CRO) delivering integrated preclinical drug development services to pharmaceutical companies, biotech firms, and research institutions globally.
With a client base of over 2,000 organizations, Medicilon supports the full spectrum of drug discovery and development—from early-stage research to IND-enabling studies—with a strong emphasis on compliance, innovation, and speed-to-market.
Medicilon continues to expand investment in R&D infrastructure, novel technologies, and global regulatory alignment to meet the evolving needs of the pharmaceutical industry and accelerate the path from lab to clinic.
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions! Learn More!