US FDA Inspection Concludes with Zero Observations
ChemExpress focuses on providing small molecule and new modalities CDMO services for both pharmaceutical and biotech clients.We are proud to announce that we have received EIR with the conclusion of the inspection, no FDA 483, Observations, was issued by US FDA on August 8th.
We 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.
About ChemExpress
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.