About us

About APIC

APIC is one of CEFIC‘s Sector Groups, comprising producers of active pharmaceutical ingredients (APIs) and intermediates in Europe. For this reason APIC considers itself to be a very important stakeholder in new EU Regulations and Guidelines related to APIs and intermediates. Our 64 members are located all over Europe and include three national associations: AFAQUIM (Spain), PHARMACHEMICAL IRELAND (Ireland) and SICOS (France).

APIC‘s key objectives are:

• To promote the use of compliant APIs in medicinal products to ensure patient safety.
• To represent the interests of pharmaceutical and chemical companies producing APIs and intermediates in Europe by being recognized experts who advance and influence the global GMP and Regulatory Environment.

APIC is very active in communicating and monitoring developments of the active pharmaceutical ingredients industry as well as in defending the APIC views and positions on proposed legislation, regulations and Guidelines.

APIC‘s membership consists of companies from different pharmaceutical industry sectors, all involved in the manufacture of APIs. This provides an ideal basis for developing and communicating a balanced, holistic view on API-related regulations and guidelines. APIC’s focus is on worldwide Quality, Good Manufacturing Practice (GMP) and Regulatory matters relating to APIs and Intermediates. Through the years APIC has developed into a highprofile industry association with an excellent, worldwide reputation.

APIC‘s Best Practice Documents

APIC has developed many Best Practice Documents such as the ICH Q7 How-to-do Guide, the APIC Audit Programme, and Position Papers e.g. on API Starting Material, Post-approval Changes and many more.

To the APIC/CEFIC website