FFuzkk Atlas of China
#5Official Top 100

Fosun Pharma

上海复星医药（集团）股份有限公司

#5

Chemical medicines and finished dosage formsBiologicsVaccines and blood productsMedical devices

Manufacturing profile

Chemical medicines and finished dosage forms
Biologics
Vaccines and blood products
Medical devices

Region: Shanghai

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. 6Cell bank or microbial seed
  7. 7Upstream culture or fermentation
  8. 8Clarification and chromatography
  9. 9UF/DF, formulation and sterile filtration

Relevant FUZKK packages

Global API & Biosimilars QC SuiteChina: national essential medicines QC packageHuvac — Human Vaccine QC UtilitiesPlasma-Derived Products QC SuiteMedical Devices Standards & Lifecycle QC SuiteMedical Device Risk Management SuiteMedical Device Software SuiteElectrical Safety & EMC SuiteLumex QC SuiteLabEx QC Suite

Product/API utilities

Assay & Impurities Result ReviewerResidual Host Cell DNA Quality CheckerResidual Host Protein CheckerVaccine Potency AssessorAdjuvant Aluminum Assay CheckerAdjuvant Adsorption Efficiency Quality CheckerInactivated Vaccine Safety Test Quality CheckerLive Attenuated Vaccine Genetic Stability Quality CheckerPlasma Pool Traceability CheckerPlasma Viral Clearance Evidence CheckerCold Chain Shipping Temperature And MKT Quality CheckerCompanion Diagnostic Report Checker

Lumex — instrumental QC

CE Glycosylation ProfilerGenotoxic Impurity Screener M7Content Uniformity Acceptance ValueDissolution Profile f2 CalculatorCE Chiral Separation CheckerAAS Elemental Impurities Class1LabWare CDS Bridge ConnectorCE mAb Aggregates FragmentsCE mAb Charge Variant CheckerCE Recombinant Protein Purity

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerContent Uniformity Quality CheckerDissolution Apparatus 1 & 2 Quality CheckerStability Condition Monitoring Quality CheckerBiologic Aggregate Size Quality CheckerCharge Variant CE Quality CheckerProtein Concentration UV Quality Checker

Medical Devices — equipment and software lifecycle

Process Validation CheckerData Integrity Security CheckerDesign Control Compliance CheckerRisk Management Report Completeness CheckerRisk Control Traceability CheckerRequirement Traceability CheckerSoftware Safety Class CheckerCybersecurity Risk Assessment CheckerElectrical Safety Test Summary CheckerEMCTest Coverage CheckerUDIData Completeness CheckerPackaging Integrity 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