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Xishan passed (NMPA) GLP certification

Release date: 2022-08-29

On August 29, 2022, the National Medical Products Administration (NMPA) organized an expert group to conduct regular laboratory GLP certification inspections on Suzhou Xishan Zhongke Pharmaceutical Research and Development Co., Ltd. Recently, the company received an inspection result notice from the Drug Registration Department of the State Food and Drug Administration: The unit basically complies with GLP requirements in terms of organization, management and personnel, instruments, equipment and experimental materials, standard operating procedures and test operations for drug safety evaluation, and is carcinogenic. Tests, single and multiple dose toxicity tests (rodents), single and multiple dose toxicity tests (non-rodents), toxicokinetic tests, immunogenicity tests, safety pharmacology tests, local toxicity tests , Reproductive toxicity test (section I, II, III), genotoxicity test (Ames, micronucleus, chromosomal aberration, mouse lymphoma test) items comply with GLP regular inspection requirements. In the future, Suzhou Xishan Zhongke will stick to its original intention and move forward firmly, provide good drug registration, pharmacology and toxicology CRO technical services, and add support to the innovation and development of medicine!

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