cGMP Manufacturing

cGMP Manufacturing
Product Description

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 µg/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

Yuhan Corporation

  • KR
  • 2015
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO
Specifications
  • Selling Points
    Convenience; Experienced Technicians; International Approvals/Standards; Prompt Delivery; Quality Service; Reputation; Sustainability
  • Supplied from
    Korea, Republic of

Yuhan Corporation

  • KR
  • 2015
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO

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