FFuzkk Atlas of China
#92Official Top 100

Huali Pharma

华立医药集团有限公司

#92

APIs, intermediates and CDMOTCM and herbal productsAntimalarial products

Manufacturing profile

APIs, intermediates and CDMO
TCM and herbal products
Antimalarial products

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. 6Receipt and identification of botanical materials
  7. 7Extraction and concentration
  8. 8Drying, blending and granulation
  9. 9HPLC/GC fingerprinting

Relevant FUZKK packages

Global API & Biosimilars QC SuiteFermentation & Antibiotic Intermediates QC SuiteHerbal / TCM / Ayurveda Instrumental QC SuiteBritish Herbal Pharmacopoeia QC SuiteWorld API Extension QC SuiteLumex QC SuiteChina: national essential medicines QC package

Product/API utilities

Chromatographic Fingerprint Similarity CheckerHerbal Chromatographic Fingerprint AnalyzerHerbal Multi Component Assay CheckerTCMDecoction Consistency CheckerHerbal Pesticide Residue CheckerHerbal Mycotoxin Limit CheckerHerbal Heavy Metals Screening CheckerHerbal Extract Solvent Residue CheckerTotal Ash In Herbal Checker

Lumex — instrumental QC

Method Validation Data PackagerGenotoxic Impurity Screener M7AAS Catalyst Residues Pd Pt RhCE Chiral Separation CheckerLabWare CDS Bridge ConnectorAAS Heavy Metals Plant MaterialFluorat Aflatoxin ScreenerFluorat Mycotoxins OchratoxinCE Inorganic Ions Analyzer

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerLC-MS Confirmation Quality CheckerStability Condition Monitoring 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