Recently, the National Medical Products Administration (NMPA) conducted regular inspections on Medicilon Biopharmaceutical’s implementation of the “GLP”. The inspection results showed that Medicilon is in the organization and management of drug safety evaluation. And results, whether the personnel, equipment and experimental materials, standard operating procedures and test operation meet the GLP requirements. The inspection results showed that the single and multiple toxicity tests (stay teeth), single and multiple dose toxicity tests (non-hypertensive teeth), and reproductive toxicity tests (I, II) applied by Medicilon, Genotoxicity test (Ames, micronucleus, staining aberration), local toxicity test, immunogenicity test, safety pharmacological test, toxicokinetic test and other items comply with GLP regulations.
Since its establishment in 2004, Medicilon has gained domestic and international recognition with years of industry accumulation and professional service spirit. Medicilon focuses on pre-clinical pharmacokinetics and safety evaluation research, and has obtained AAALAC (International Association for Animal Evaluation and Certification) certification and National Medical Products Administration GLP certificate, which meets the US FDA GLP standard.
Medicilon successfully passed the US FDA GLP on-site inspection