API Site Change Notification Explained: Ultimate Guide to Regulatory Submissions and Compliance Mastering API Site Change Notifications: Compliance-Driven Guide for Regulatory Affairs Professionals Introduction to API Site Change Notifications and Their Importance API site change notifications are regulatory submissions required when the manufacturing, testing, or packaging of an Active Pharmaceutical Ingredient (API) is transferred from one facility to another. Regulatory agencies such as the FDA, EMA, and CDSCO mandate strict site change approvals to ensure continued compliance with Good Manufacturing Practice (GMP) and to maintain the quality, safety, and efficacy of APIs. By 2025, API site change notifications have become…