FFuzkk Atlas of China
#39Official Top 100

HEC Group

深圳市东阳光实业发展有限公司

#39

Chemical medicines and finished dosage formsPeptides and insulinsBiologics

Manufacturing profile

Chemical medicines and finished dosage forms
Peptides and insulins
Biologics

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 packagePeptides, GLP-1 and Obesity QC SuiteLumex QC SuiteLabEx QC Suite

Product/API utilities

Assay & Impurities Result ReviewerInsulin Analog Impurity CheckerHuman Insulin Quality CheckerGLP1 Injectable Release CheckerResidual Host Cell DNA Quality CheckerResidual Host Protein Checker

Lumex — instrumental QC

CE Peptide Map ValidatorCE Peptide Map FingerprintInsulinHumanHPLCCheckerCE Glycosylation ProfilerGenotoxic Impurity Screener M7Content Uniformity Acceptance ValueDissolution Profile f2 CalculatorCE Chiral Separation CheckerAAS Elemental Impurities Class1LabWare CDS Bridge Connector

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 CheckerLC-MS Confirmation Quality CheckerBacterial Endotoxins LAL Quality CheckerSterility Test Membrane Filtration 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