FFuzkk Atlas of China
#55Official Top 100

Kangnong Pharma

浙江康恩贝制药股份有限公司

#55

TCM and herbal productsOTC and consumer health

Manufacturing profile

TCM and herbal products
OTC and consumer health

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. 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
  6. 6Raw-material receipt and identification
  7. 7Dispensing, blending and granulation
  8. 8Tableting, encapsulation or solution preparation
  9. 9Packaging and labelling

Relevant FUZKK packages

Herbal / TCM / Ayurveda Instrumental QC SuiteBritish Herbal Pharmacopoeia QC SuiteChina: national essential medicines QC packageGlobal API & Biosimilars QC Suite

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 CheckerParacetamol Quality CheckerIbuprofen Quality CheckerIbuprofen Paracetamol Quality Checker

Lumex — instrumental QC

AAS Heavy Metals Plant MaterialFluorat Aflatoxin ScreenerFluorat Mycotoxins OchratoxinCE Inorganic Ions AnalyzerLabWare CDS Bridge ConnectorContent Uniformity Acceptance ValueDissolution Profile f2 CalculatorFluorat B Complex Vitamins

LabEx — laboratory QC

Water Content KF Quality CheckerAssay & Impurity HPLC Quality CheckerDissolution Apparatus 1 & 2 Quality CheckerContent Uniformity Quality CheckerMicrobial Enumeration (TAMC/TYMC) Quality CheckerSpecified Microorganisms Quality CheckerStability Condition Monitoring Quality CheckerElemental Impurities ICP Quality Checker

Medical Devices — equipment and software lifecycle

Packaging Integrity CheckerSupplier Evaluation CheckerIncoming Inspection Sampling 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