API

Starting materials that are manufactured at site with:

EUGMP certification inspected by an EU member state

A state with a recognised GMP standard by a non EU competent authority such as Iceland, Liechtenstein, Norway, Australia, Brazil, Israel, Japan, Switzerland and the USA.

A Written Confirmation declaring that the site has equivalence to EUGMP.

The material will be named on the GMP validation document. These materials will also have a DMF/ ASMF.