FFuzkk Atlas of China
#36Official Top 100

Apeloa Pharma

普洛药业股份有限公司

#36

APIs, intermediates and CDMOChemical medicines and finished dosage forms

Manufacturing profile

APIs, intermediates and CDMO
Chemical medicines and finished dosage forms

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. 1Route development and raw materials
  2. 2Synthesis or fermentation
  3. 3Crystallisation, filtration and drying
  4. 4Milling and controlled packaging
  5. 5HPLC/GC/KF/ICP/LC-MS and validation evidence
  6. 6Raw-material receipt and identification
  7. 7Dispensing, blending and granulation
  8. 8Tableting, encapsulation or solution preparation
  9. 9Packaging and labelling

Relevant FUZKK packages

Global API & Biosimilars QC SuiteFermentation & Antibiotic Intermediates QC SuiteChina: national essential medicines QC packageWorld API Extension QC SuiteLumex QC SuiteLabEx QC Suite

Product/API utilities

Assay & Impurities Result Reviewer

Lumex — instrumental QC

Method Validation Data PackagerGenotoxic Impurity Screener M7AAS Catalyst Residues Pd Pt RhCE Chiral Separation CheckerLabWare CDS Bridge ConnectorContent Uniformity Acceptance ValueDissolution Profile f2 CalculatorAAS Elemental Impurities Class1

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerLC-MS Confirmation Quality CheckerContent Uniformity Quality CheckerDissolution Apparatus 1 & 2 Quality CheckerStability Condition Monitoring Quality Checker

Medical Devices — equipment and software lifecycle

Process Validation CheckerChange Control Impact CheckerSupplier Evaluation CheckerProduction Record Consistency CheckerData Integrity Security CheckerRelease Readiness CheckerCalibration Status 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