#USA #Boston #FDA #Medicilon #R&D Excellence

Medicilon Successfully Passes FDA Inspection

On May 20, 2025, Medicilon Preclinical Research (Shanghai) LLC, known simply as Medicilon, announced its successful completion of an on-site FDA inspection. This inspection was a significant milestone for the company, reaffirming its position as a trusted leader in the preclinical research sector.

A Major Compliance Milestone

The FDA inspection was thorough and examined many facets of Medicilon's operations. Inspectors assessed the company’s organizational structure, staff qualifications, standard operating procedures, facility integrity, documentation processes, experimental operations, quality assurance systems, and computerized infrastructures. Additionally, several research projects submitted to the FDA were scrutinized.

The inspectors commended Medicilon for its scientific discipline and operational excellence, expressing eagerness to see the continuation of high-quality data submissions. This positive feedback further solidifies Medicilon's commitment to its guiding philosophy of 'Quality First.'

Strategic Validation of Global R&D Impact

This FDA inspection marked Medicilon's first in seven years, and its successful outcome significantly enhances the company’s regulatory credibility. This step strongly supports its strategic vision, which is centered on being 'Innovation Driven, Quality Focused.'

By the end of 2024, Medicilon had aided an impressive total of 520 new experimental drugs in entering clinical trial phases. These drugs received approvals from multiple regulatory authorities, including the Chinese NMPA, U.S. FDA, European EMA, Australian TGA, and South Korean KFDA. The innovative drugs range from 34 monoclonal antibodies to various other therapeutic options like GLP-1 medications and PROTACs. Medicilon continues to invest heavily in technological innovation and R&D, aspiring to launch even more innovative and higher quality solutions and services.

Embracing Pharmacy Market Opportunities

Medicilon is committed to addressing the vast opportunities and challenges within the global pharmaceutical market while also promoting the growth of the pharmaceutical industry worldwide.

About Medicilon

Founded in 2004, Shanghai Medicilon Inc. (stock code 688202.SH) has dedicated itself to providing comprehensive R&D services to pharmaceutical companies, research institutions, and organizations involved in preclinical projects. By the end of 2024, Medicilon had offered drug development services to over 2,000 clients globally and played a crucial role in the research and development of 520 new drugs and generic drug projects that received approval for clinical trials via new drug applications. With its track record, Medicilon clearly demonstrates its unwavering commitment to enhancing the landscape of pharmaceutical innovation.

In conclusion, the successful completion of the FDA inspection is not only a testament to Medicilon’s excellence in R&D but also a significant stepping stone towards its future endeavors in the pharmaceutical sector, which is increasingly characterized by rapid advances in technology and high standards of quality.