API sourcing guide
What to require from an API source, in what order, so a qualification does not stall halfway through waiting on a document nobody asked for early enough.
A patent database currently outranks every actual supplier on this question, which tells you how little practical guidance exists. The sequence matters more than the checklist: samples before comparative work, documentation before audit, audit before commitment.
This guide is in preparation and will cover the documentation set, the DMF question, and how to run a second-source qualification without duplicating work.
The documentation set
What to require, and when in the process to require it.
DMF or not
When a Drug Master File matters to your filing and when it does not.
Qualification sequence
The order that avoids duplicated comparative work.
Related
Neck Finish Guide
How to read a neck finish callout and match a closure to a container.
Cap Liner Selection
Choosing a liner against fill temperature, pH and process.
DMF vs CEP
Which regulatory route applies to your filing, and where.
Lead Time and Incoterms
Where the time actually goes, and who carries which risk.
Request a Quote
Send the specification and the volume. We come back with pricing, lead time and Incoterms within two business days.