FFuzkk Atlas of China
#51Official Top 100

Lukang Pharma

山东鲁抗医药股份有限公司

#51

Antibiotics and fermentationAPIs, intermediates and CDMOVeterinary products

Manufacturing profile

Antibiotics and fermentation
APIs, intermediates and CDMO
Veterinary products

Region: Shandong

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. 6Route development and raw materials
  7. 7Synthesis or fermentation
  8. 8Crystallisation, filtration and drying
  9. 9Milling and controlled packaging

Relevant FUZKK packages

Fermentation & Antibiotic Intermediates QC SuiteGlobal API & Biosimilars QC SuiteVet — Veterinary QC UtilitiesWorld API Extension QC SuiteLumex 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 CheckerHerd Flock Vaccine Batch Review UtilityAutogenous Vaccine Batch Traceability Utility

Lumex — instrumental QC

Method Validation Data PackagerAmoxicillinDegradationCheckerCeftriaxoneSodiumPurityCheckerCiprofloxacinImpurityCheckerInfraLUM ID AmoxicillinInfraLUM ID CeftriaxoneInfraLUM ID CiprofloxacinLabWare CDS Bridge ConnectorGenotoxic Impurity Screener M7AAS Catalyst Residues Pd Pt Rh

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerLC-MS Confirmation Quality CheckerMicrobial Enumeration (TAMC/TYMC) 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