Investor Presentaiton
Wuxi ATU Quality and Regulatory
Consistently Deliver Quality Compliance & Regulatory Services
2023 H1
Highlights
FDA U.S. FOOD & DRUG
ADMINISTRATION
Audit and
Inspections
国家药品监督管理局
National Medical Products Administration
Inspection & Certification: 2
Client & Internal Audit: 45
1st health authority inspection
for the China facility; pre-
licensure inspection for US
facility scheduled in Q3-2023
Client
Submission
Support
(US, EU &
CN)
• Pre-IND: 3
•
IND: 6
.
BLA: 3
ilac-MRA
6 IND approved in 2023 H1
■
US Philadelphia FEI #1000122198;
Active Type V DMF for all four facilities
China Huishan FEI #3017796768
Recent
Inspection/Certification
March 2023; NMPA (China) Inspection
March 2023; ISO 17025 Re-certification
August 2022; USDA Inspection
March 2022; TGA (Australia) GMP Inspection
December 2021; EMA GMP Inspection
June 2021; USDA Inspection
February 2021; ISO 17025 Re-certification
January 2020; FDA GMP Inspection
December 2019; EMA GMP Inspection
March 2019; TGA (Australia) GMP Inspection
March 2019; PMDA (Japan) GCTP Inspection
? Wuxi AppTec
药明康德View entire presentation