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An IS0 9001:2015 Certified Institute

Drug Substances (API)

Drug Substances (API)

About the course:-

The dosage form for a pharmaceutical contains the active pharmaceutical ingredient, which is the drug substance itself, and excipients, which are the ingredients of the tablet, or the liquid in which the active agent is suspended, or other material that is pharmaceutically inert. Drugs are chosen primarily for their active ingredients. During formulation development, the excipients are chosen carefully so that the active ingredient can reach the target site in the body at the desired rate and extent.

Objective of the course:-


Course Syllabus

Topic : 1 Introduction to RA

Topic : 2 CMC of API

API development, polymorphism, impurities, deficiencies and how to respond effectively.

Topic : 3 CTD – eCTD

Introduction about CTD/eCTD, origin of CTD and brief description about Module 3 – Quality Part- S (drug substance)

Topic : 4 Drug substance submission in US

US(FDA) Introduction, Patents and their types, GDUFA, Post approval changes (Annual reports, CB-30 and prior approval supplements) and Types of DMF’s.

Topic : 5 Drug substance submission in Europe

Drug regulatory authorities in European Union (EU), different types of approval procedures (MRP, DCP, National and Centralized Procedures), brief study on post approval changes (variations and extensions) and approval procedures for drug substance (DMF and CEP).

Course Features

Instructor Live Sessions

There will be allocated hours of instructor with Live classroom and Simultaneously on Online.


Each class will be followed by practical assignments which can be completed before the next class.

24/7 Support

We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.


Towards the end of the course, you will be working on a project. Sadhana Infotech certifies you as an course Expert based on the project.

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