2Y-Biopharma Successfully Completes U.S. FDA PAI with no Form 483
2Y-Biopharma Completes U.S. FDA PAI with No Form 483
Recently, 2Y-Biopharma, a wholly owned subsidiary of Shanghai Haoyuan Chemexpress Co, Ltd. ("ChemExpress") for drug product GMP manufacturing, successfully completed a Pre-Approval Inspection (PAI) conducted by the U.S. Food and Drug Administration (FDA), with no Form 483 observations.
The inspection was conducted from June 22 to 26, 2026. 2Y-Biopharma has since received the Establishment Inspection Report (EIR) for the inspection. The successful completion of the PAI with no Form 483 observations marks an important milestone in the continued development of the company's global quality and compliance system for its drug product business.
Mr. Wensheng Tang
Co-founder and GM of 2Y-Biopharma
“We are pleased to have received the EIR following the successful completion of the FDA Pre-Approval Inspection with no Form 483 observations. This positive inspection outcome further strengthens the regulatory compliance foundation for our drug product business as we expand into the U.S. market, while also enhancing the global competitiveness of our drug product capabilities.”
The successful completion of the PAI and receipt of the EIR represent an important regulatory milestone for 2Y-Biopharma. This achievement further strengthens ChemExpress's integrated CDMO capabilities spanning regulatory starting materials, novel building blocks, intermediates, reference compounds, APIs, biologics and drug products, further supporting clients from process development through commercialization.
About 2Y-Biopharma
2Y-Biopharma is a core drug product manufacturing site of ChemExpress. In recent years, 2Y-Chem and 2Y-Biopharma have supported 10 MAH clients in achieving marketing approvals of innovative or generic drugs and have been entrusted for commercial production. The platform features expertise in solubility enhancement for poorly soluble drugs, including spray drying, hot-melt extrusion, lyophilization, and fluidized-bed ASD technologies, as well as modified-release and topical semi-solid formulation technologies. We are committed to excellence in drug development and contract manufacturing services, accelerating drug innovation from laboratory to pharmacy, benefiting patients around the world!
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