Notes on making APIs
Practical writing on process development, scale-up, quality and regulatory filing for people who source or develop active pharmaceutical ingredients.
What a Drug Master File is, and how a Letter of Access works
A plain guide for formulators: what an API maker files in a DMF, what stays confidential, and what a Letter of Access lets you reference.
Read the article →From lab route to plant: what changes when an API process scales up
Heat, mixing, time and solids all behave differently in a reactor than in a flask. Here is what a process-development team checks at each step.
Read the article →Why polymorph control matters in API manufacturing
The same molecule can crystallise in more than one form. Which one you get affects solubility, stability and how the API behaves in a tablet.
Read the article →More articles are on the way. Starter articles are drafts to review by Nivika's technical team before publication.