FFuzkk Atlas of China
#139FUZKK selection 101–1000

BBCA Pharma

安徽丰原药业股份有限公司

#139

APIs, intermediates and CDMO

Manufacturing profile

APIs, intermediates and CDMO

Region: Anhui

Selection basis

The company was selected from a public production/supply universe as a legal entity with strong pharmaceutical-manufacturing indicators. Positions 101–1000 are FUZKK atlas priorities, not an official revenue ranking.

Score
215
Public source order
18
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

Relevant FUZKK packages

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

Product/API utilities

Assay & Impurities Result Reviewer

Lumex — instrumental QC

Method Validation Data Packager

LabEx — laboratory QC

Assay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality CheckerElemental Impurities ICP Quality CheckerLC-MS Confirmation Quality Checker

Medical Devices — equipment and software lifecycle

Process Validation CheckerChange Control Impact CheckerSupplier Evaluation CheckerProduction Record Consistency CheckerCalibration Status CheckerRequirement Traceability CheckerData Integrity Security 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