FFuzkk Atlas of China
#23Official Top 100

Zhuhai United Labs

珠海联邦制药股份有限公司

#23

Antibiotics and fermentationPeptides and insulinsChemical medicines and finished dosage forms

Manufacturing profile

Antibiotics and fermentation
Peptides and insulins
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. 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

Relevant FUZKK packages

Fermentation & Antibiotic Intermediates QC SuiteGlobal API & Biosimilars QC SuitePeptides, GLP-1 and Obesity QC SuiteChina: national essential medicines QC packageLumex 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 CheckerInsulin Analog Impurity CheckerHuman Insulin Quality CheckerGLP1 Injectable Release CheckerAssay & Impurities Result Reviewer

Lumex — instrumental QC

CE Peptide Map ValidatorCE Peptide Map FingerprintInsulinHumanHPLCCheckerAmoxicillinDegradationCheckerCeftriaxoneSodiumPurityCheckerCiprofloxacinImpurityCheckerInfraLUM ID AmoxicillinInfraLUM ID CeftriaxoneInfraLUM ID CiprofloxacinLabWare CDS Bridge Connector

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerLC-MS Confirmation Quality CheckerBacterial Endotoxins LAL Quality CheckerSterility Test Membrane Filtration 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 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