3.2.S.2.1 - Manufacturer(s)

The name, address and responsibility of the units that perform manufacturing steps of intermediates and API and quality control of the API, from the introduction of the starting material(s), should be provided

When physical steps (e.g., milling, micronization, lyophilization) or sterilization are performed by the DIFA holder of under its oversight, the unit(s) should be included, as well as contractors.