FFuzkk Atlas of China
#4Official Top 100

China Grand Enterprises

中国远大集团有限责任公司

#4

Chemical medicines and finished dosage formsRadiopharmaceuticalsOphthalmic products

Manufacturing profile

Chemical medicines and finished dosage forms
Radiopharmaceuticals
Ophthalmic products
Official website

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. 6Radionuclide production or generator handling
  7. 7Shielded synthesis and hot-cell operations
  8. 8Sterile filtration and aseptic dispensing
  9. 9Activity and radionuclidic/radiochemical purity

Relevant FUZKK packages

Global API & Biosimilars QC SuiteChina: national essential medicines QC packageRPH: combined radiopharmaceutical QC packageRadioligand & Theranostics Expansion QC SuiteOphthalmic & Intravitreal QC SuiteLabEx QC SuiteLumex QC Suite

Product/API utilities

Assay & Impurities Result ReviewerRadionuclidic Purity CheckerCold Chain Shipping Temperature And MKT Quality CheckerOphthalmic Solution Quality CheckerOphthalmic Osmolality PHCheckerOphthalmic Particulate Matter CheckerOphthalmic Container Closure Integrity CheckerOphthalmic Extractables Leachables CheckerOphthalmic Sterility Endotoxin Ultra CheckerBismuth-213 Quality CheckerActinium225 Quality CheckerOphthalmic Sterility Workflow Checker

Lumex — instrumental QC

Genotoxic Impurity Screener M7Content Uniformity Acceptance ValueDissolution Profile f2 CalculatorCE Chiral Separation CheckerAAS Elemental Impurities Class1LabWare CDS Bridge ConnectorCE Inorganic Ions AnalyzerAAS Glass Leachables Test

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 CheckerBacterial Endotoxins LAL Quality CheckerSterility Test Membrane Filtration 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