ChemExpress have received EIR with the conclusion of the inspection

ChemExpress have received EIR with the conclusion of the inspection, no FDA 483, Observations, was issued by US FDA on August 8th.

ChemExpress have completed a Pre-Approval Inspection (PAI) at our Shanghai site. The inspection of the drug substance facility was carried out from June 11 to June 14, 2024, and concluded with zero 483 observations. This result confirms the FDA's recognition of our commitment to quality in pharmaceutical development and data integrity. Passing this US FDA inspection also enables us to better serve our customers. This achievement reflects the collective effort of our team, we greatly appreciate the hard work and dedication of all our employees, which aligns perfectly with our company's vision: Client-Focused and Innovation-Driven. ChemExpress is committed to offering our partners a high quality, highly efficient end-to-end service platform that focuses on small molecules and new modalities, including ADC Payloads & linkers, peptides, oligonucleotides, protacs, etc. Our comprehensive CRO & CDMO platform provides full lifecycle services from R&D through commercialization, and supply of reference compounds, building blocks, RSMs, intermediates, APIs and drug products.