SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE

For critical raw materials, intermediates and API’s, it is recommended there should be a due diligence assessment, a more detailed assessment of the quality system and material evaluation should involve laboratory or plant trials prior to full production assessment.

  Intermediate

ANDA CHECKLIST FOR CTD FORMAT - MAX-Sourcing

3. Type II DMF number for API 4. CFN or FEI numbers 3.2.S.3 Characterization 3.2.S.4 Control of Drug Substance (Active Pharmaceutical Ingredient) 3.2.S.4.1 Specification Testing specifications and data from drug substance manufacturer(s) 3.2.S.4.2 Analytical Procedures

The next phase: Opportunities in China's pharmaceuticals ...

Intermediates API Pharmaceutical company Active Pharmaceutical Ingredients (API) Pharmaceutical Drug distribution company Traditional distributors 85% Special types distributors 10% Others: Direct marketing, etc. 5% Drug stores (Chain/individual) 20% Medical service provider Hospitals (Public/army/ private) 80% Commercial healthcare

  Pharmaceutical, Active, Ingredients, Active pharmaceutical ingredients, Intermediate, Intermediates api