FFuzkk Atlas of China
#80Official Top 100

Xianju Pharma

浙江仙琚制药股份有限公司

#80

Hormones and high-potency APIsAPIs, intermediates and CDMO

Manufacturing profile

Hormones and high-potency APIs
APIs, intermediates and CDMO

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. 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

Global API & Biosimilars QC SuiteEndocrinology QC SuiteFermentation & Antibiotic Intermediates QC SuiteWorld API Extension QC SuiteLumex QC Suite

Product/API utilities

Estradiol Quality CheckerDexamethasone Quality CheckerBetamethasone Quality CheckerDesogestrel Quality Checker

Lumex — instrumental QC

Method Validation Data PackagerCE Chiral Separation CheckerAAS Catalyst Residues Pd Pt RhGenotoxic Impurity Screener M7LabWare CDS Bridge Connector

LabEx — laboratory QC

Chiral Purity HPLC Quality CheckerAssay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerContent Uniformity Quality CheckerLC-MS Confirmation Quality Checker

Medical Devices — equipment and software lifecycle

Change Control Impact CheckerProcess Validation 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