Medicilon Achieves FDA Approval, Reinforcing Global R&D Excellence
On May 20, Medicilon Preclinical Research (Shanghai) LLC announced the successful completion of a comprehensive FDA inspection at its facilities, having received an Establishment Inspection Report (EIR). This critical achievement cements Medicilon's status as a trusted leader in preclinical research and development services.
The FDA inspection was thorough, focusing on several critical components of Medicilon's operations. Inspectors evaluated the organizational structure, the qualifications of personnel, standard operating procedures, facility integrity, documentation practices, experimental work, quality assurance systems, and computer infrastructure. Additionally, a review of several research projects submitted to the FDA was conducted. The FDA personnel praised Medicilon for its scientific discipline and operational excellence, setting high expectations for continued delivery of quality data. This recognition affirms Medicilon's unwavering commitment to its guiding philosophy: "Quality First."
This was Medicilon's first FDA inspection in seven years, and the positive outcome greatly enhances the company's regulatory credibility. The milestone serves as a testament to the strategic vision of Medicilon, grounded in a foundation of "innovation-driving strength and a focus on quality."
By the end of 2024, Medicilon had enabled the initiation of clinical trials for 520 new investigational drugs, facilitated by approvals from regulatory agencies including China's National Medical Products Administration (NMPA), the U.S. FDA, the European Medicines Agency (EMA), the Therapeutic Goods Administration (TGA) in Australia, and the Korean Food and Drug Administration (KFDA). These drugs span a variety of innovative pharmaceutical developments, including 34 antibodies, 28 antibody-drug conjugates (ADCs), 8 GLP-1 analogs, 6 proteolysis-targeting chimera (PROTAC) drugs, and 3 plant-based medicines.
Looking ahead, Medicilon plans to further increase investments in technological innovations and research and development, while also introducing more innovative technologies and services of enhanced quality. With a proactive approach to welcoming a broad array of opportunities and challenges in the global pharmaceutical market, Medicilon is set to support industry growth and development.
Since its inception in 2004, Shanghai Medicilon Inc. (Stock Code 688202.SH) has aimed to provide comprehensive research and development services to pharmaceutical companies, research institutions, and other organizations engaged in preclinical research. As of the end of 2024, Medicilon had offered drug development services to over 2,000 clients worldwide, participating in the research and development of 520 new drugs and projects that include generic medications approved for clinical trials as new investigational drugs.
The FDA inspection was thorough, focusing on several critical components of Medicilon's operations. Inspectors evaluated the organizational structure, the qualifications of personnel, standard operating procedures, facility integrity, documentation practices, experimental work, quality assurance systems, and computer infrastructure. Additionally, a review of several research projects submitted to the FDA was conducted. The FDA personnel praised Medicilon for its scientific discipline and operational excellence, setting high expectations for continued delivery of quality data. This recognition affirms Medicilon's unwavering commitment to its guiding philosophy: "Quality First."
This was Medicilon's first FDA inspection in seven years, and the positive outcome greatly enhances the company's regulatory credibility. The milestone serves as a testament to the strategic vision of Medicilon, grounded in a foundation of "innovation-driving strength and a focus on quality."
By the end of 2024, Medicilon had enabled the initiation of clinical trials for 520 new investigational drugs, facilitated by approvals from regulatory agencies including China's National Medical Products Administration (NMPA), the U.S. FDA, the European Medicines Agency (EMA), the Therapeutic Goods Administration (TGA) in Australia, and the Korean Food and Drug Administration (KFDA). These drugs span a variety of innovative pharmaceutical developments, including 34 antibodies, 28 antibody-drug conjugates (ADCs), 8 GLP-1 analogs, 6 proteolysis-targeting chimera (PROTAC) drugs, and 3 plant-based medicines.
Looking ahead, Medicilon plans to further increase investments in technological innovations and research and development, while also introducing more innovative technologies and services of enhanced quality. With a proactive approach to welcoming a broad array of opportunities and challenges in the global pharmaceutical market, Medicilon is set to support industry growth and development.
Since its inception in 2004, Shanghai Medicilon Inc. (Stock Code 688202.SH) has aimed to provide comprehensive research and development services to pharmaceutical companies, research institutions, and other organizations engaged in preclinical research. As of the end of 2024, Medicilon had offered drug development services to over 2,000 clients worldwide, participating in the research and development of 520 new drugs and projects that include generic medications approved for clinical trials as new investigational drugs.
Topics Health）
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