FFuzkk Atlas of China
#68Official Top 100

Luye Pharma

烟台绿叶医药控股（集团）有限公司

#68

Chemical medicines and finished dosage formsSterile productsOncology, ADC and high-potency

Manufacturing profile

Chemical medicines and finished dosage forms
Sterile products
Oncology, ADC and high-potency

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 SuiteChina: national essential medicines QC packageLabEx QC SuiteSterile Medical Devices SuiteADC / Conjugated Biologics QC SuiteLumex QC Suite

Product/API utilities

Assay & Impurities Result ReviewerWater For Injections Quality CheckerFill Volume & Container Closure CheckerADC Aggregation MonitorADC Drug Antibody Ratio AnalyzerADC Free Payload QuantifierADC Linker Stability ProfilerADCRelease Readiness Checker

Lumex — instrumental QC

Genotoxic Impurity Screener M7Content Uniformity Acceptance ValueDissolution Profile f2 CalculatorCE Chiral Separation CheckerAAS Elemental Impurities Class1LabWare CDS Bridge ConnectorAAS Glass Leachables TestCE Inorganic Ions AnalyzerCE mAb Aggregates FragmentsCE mAb Charge Variant Checker

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 CheckerSterility Test Membrane Filtration Quality CheckerBacterial Endotoxins LAL Quality CheckerParticle Count Injection USP <788> Quality Checker

Medical Devices — equipment and software lifecycle

Process Validation CheckerData Integrity Security CheckerRelease Readiness CheckerSupplier Evaluation CheckerCalibration Status CheckerChange Control Impact CheckerRequirement Traceability 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