FFuzkk Atlas of China
#54Official Top 100

Asymchem

凯莱英医药集团（天津）股份有限公司

#54

APIs, intermediates and CDMOPeptides and insulins

Manufacturing profile

APIs, intermediates and CDMO
Peptides and insulins

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 SuitePeptides, GLP-1 and Obesity QC SuiteWorld API Extension QC SuiteLumex QC Suite

Product/API utilities

Insulin Analog Impurity CheckerHuman Insulin Quality CheckerGLP1 Injectable Release Checker

Lumex — instrumental QC

Method Validation Data PackagerCE Peptide Map ValidatorCE Peptide Map FingerprintInsulinHumanHPLCCheckerGenotoxic Impurity Screener M7AAS Catalyst Residues Pd Pt RhCE Chiral Separation CheckerLabWare CDS Bridge ConnectorCE Recombinant Protein Purity

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerLC-MS Confirmation Quality CheckerBacterial Endotoxins LAL Quality CheckerSterility Test Membrane Filtration Quality CheckerParticle Count Injection USP <788> 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