About ApiBureau

ApiBureau is a cross-region pharmaceutical registration intelligence platform. We match CDE, FDA DMF, and EMA CEP data to help you track global pharmaceutical supply chain布局.

What We Track

  • 🇨🇳 CDE Registrations — China's Center for Drug Evaluation registration data, including Class A (approved) and Class I (filed) suppliers
  • 🇺🇸 FDA DMF — US Drug Master File registrations, tracking API manufacturers registered with the FDA
  • 🇪🇺 EMA CEP — European Certificate of Suitability registrations for pharmaceutical substances
  • 🔗 Cross-Region Matching — Identifying companies registered in multiple regions, enabling global supply chain intelligence

Data Scale

3,987
Companies
6,380
Products
24,273
Registrations
506
Cross-Region Companies

Data Sources

  • • CDE — China Center for Drug Evaluation (国家药品监督管理局药品审评中心) registration database
  • • FDA DMF — US Food and Drug Administration Drug Master File listings
  • • EMA CEP — European Medicines Agency Certificate of Suitability (EDQM) database
  • • WHO ATC — Anatomical Therapeutic Chemical classification system

Methodology

Company name matching across CDE, DMF, and CEP databases uses a multi-strategy approach:

  1. Exact Chinese name matching for CDE records
  2. Fuzzy English name matching with confidence scoring
  3. Manual verification for high-value cross-region matches
  4. Province/country classification from Chinese company names

Match confidence is labeled as HIGH, MEDIUM, or LOW. Only HIGH and MEDIUM matches are displayed by default.

Contact

For data licensing, API access, or enterprise solutions, please contact us at [email protected]