FFuzkk Atlas of China
#45Official Top 100

Fresenius Kabi (China)

费森尤斯卡比（中国）投资有限公司

#45

Multinational pharmaceutical operations in ChinaSterile productsMedical devices

Manufacturing profile

Multinational pharmaceutical operations in China
Sterile products
Medical devices

Selection basis

The company is included in the official 2024 ranking of the 100 largest Chinese pharmaceutical-industry enterprises by main-business revenue.

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Representative manufacturing and QC chain

  1. 1Raw-material receipt and identification
  2. 2Dispensing, blending and granulation
  3. 3Tableting, encapsulation or solution preparation
  4. 4Packaging and labelling
  5. 5HPLC, GC, KF, ICP/AAS, dissolution and stability QC
  6. 6WFI, clean steam and cleanroom HVAC
  7. 7Solution preparation and bioburden control
  8. 8Sterile filtration
  9. 9Isolator/RABS filling or lyophilisation

Relevant FUZKK packages

Global API & Biosimilars QC SuiteMedical Device QMS SuiteMedical Device Software SuiteLabEx QC SuiteSterile Medical Devices SuiteMedical Devices Standards & Lifecycle QC SuiteMedical Device Risk Management SuiteElectrical Safety & EMC SuiteChina: national essential medicines QC packageUDI & Labeling Suite

Product/API utilities

Water For Injections Quality CheckerFill Volume & Container Closure CheckerCompanion Diagnostic Report Checker

Lumex — instrumental QC

Method Validation Data PackagerLabWare CDS Bridge ConnectorGenotoxic Impurity Screener M7Content Uniformity Acceptance ValueAAS Glass Leachables TestCE Inorganic Ions Analyzer

LabEx — laboratory QC

Sterility Test Membrane Filtration Quality CheckerBacterial Endotoxins LAL Quality CheckerParticle Count Injection USP <788> Quality CheckerFilter Integrity Test Quality CheckerPackage Integrity & Leak Test Quality CheckerOsmolality Quality CheckerEnvironmental Monitoring Cleanroom Quality CheckerAssay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerStability Condition Monitoring Quality Checker

Medical Devices — equipment and software lifecycle

Change Control Impact CheckerProcess Validation CheckerData Integrity Security CheckerRequirement Traceability CheckerSupplier Evaluation CheckerProduction Record Consistency CheckerRelease Readiness CheckerDesign Control Compliance CheckerRisk Management Report Completeness CheckerRisk Control Traceability CheckerSoftware Safety Class CheckerCybersecurity Risk Assessment Checker

Suggested first pilot

  1. Confirm one real product, method or recurring QC review.
  2. Record the instrument, export format and current specification.
  3. Select 3–7 utilities from the map above.
  4. Run a PASS/FAIL sample and agree the expected output.
  5. After user validation, expand the scope.

Mapping boundary

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Methodology