FFuzkk Atlas of China
#85Official Top 100

Kangyuan Pharma

江苏康缘药业股份有限公司

#85

TCM and herbal products

Manufacturing profile

TCM and herbal products

Region: Jiangsu

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. 1Receipt and identification of botanical materials
  2. 2Extraction and concentration
  3. 3Drying, blending and granulation
  4. 4HPLC/GC fingerprinting
  5. 5Pesticides, mycotoxins, metals, ash and moisture QC

Relevant FUZKK packages

Herbal / TCM / Ayurveda Instrumental QC SuiteBritish Herbal Pharmacopoeia 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

AAS Heavy Metals Plant MaterialFluorat Aflatoxin ScreenerFluorat Mycotoxins OchratoxinCE Inorganic Ions AnalyzerLabWare CDS Bridge Connector

LabEx — laboratory QC

Water Content KF Quality CheckerAssay & Impurity HPLC Quality CheckerElemental Impurities ICP Quality Checker

Medical Devices — equipment and software lifecycle

Supplier Evaluation CheckerCalibration Status CheckerProcess Validation CheckerChange Control Impact 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