FFuzkk Atlas of China
#52Official Top 100

Hisun Pharma

浙江海正药业股份有限公司

#52

APIs, intermediates and CDMOAntibiotics and fermentationBiologics

Manufacturing profile

APIs, intermediates and CDMO
Antibiotics and fermentation
Biologics

Region: Zhejiang

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 SuiteWorld API Extension QC SuiteLumex QC SuiteLabEx QC Suite

Product/API utilities

Antibiotic Intermediate Release CheckerAntibiotic Potency Assay CheckerFermentation Impurity Profile AnalyzerFermentation Residual Solvent CheckerFermentation Bioburden Trend CheckerFermentation Yield Consistency CheckerSix APAImpurity Profile CheckerSeven ACAImpurity Profile CheckerResidual Host Cell DNA Quality CheckerResidual Host Protein Checker

Lumex — instrumental QC

Method Validation Data PackagerCE Glycosylation ProfilerGenotoxic Impurity Screener M7AAS Catalyst Residues Pd Pt RhCE Chiral Separation CheckerLabWare CDS Bridge ConnectorAmoxicillinDegradationCheckerCeftriaxoneSodiumPurityCheckerCiprofloxacinImpurityCheckerInfraLUM ID Amoxicillin

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerLC-MS Confirmation Quality CheckerBiologic Aggregate Size Quality CheckerCharge Variant CE Quality CheckerProtein Concentration UV Quality CheckerELISA Bioassay Quality CheckerSPR Binding Affinity Quality Checker

Medical Devices — equipment and software lifecycle

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