cGMP Manufacturing

1. Manufacturing facilities ensure: 1) Production flexibility at various scale 2) Total Production Capacity: 726 m3 including pilot production 3) Potent compound manufacturing (OEL Category 3A, CPT 1 Mug/m3) 2. Various Analytical Capabilities: 1) cGMP QC lab with HPLC, UPLC, GC, LC-MS, GC-MS, NMR, XRD 2) ICP-OES, ICP-MS, microbial testing capabilities and others 2) Lab fully compliant to 21 CFR part 11 requirements with comprehension 3. Successful Regulatory Approvals 1) US FDA 2) Australia TGA 3) Japan PMDA 4) Korea MFDS