To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally.
Topics include:
Safety, efficacy, and environmental/regulatory requirements
Analysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and China
The FDA's...
To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regul...