Comparative Study of Active Pharmaceutical Ingredients Related Regulatory Requirements in Japan, Saudi Arabia and India

Abstract

Pharmacological activity of any finished pharmaceutical product is a direct effect of an Active Pharmaceutical Ingredient (API) used. It is mandatory to provide the details of an active ingredients during the registration of any finished pharmaceutical products. From several decades, United States Food and Drug Administration (USFDA) had an extensive and complex set of API requirements. Europe had also given importance of API since 1990. Nowadays, various pharmaceutical industries started their own API manufacturing facilities instead of importing the same from other manufacturers. Furthermore, many industries also started outsourcing the production of API to contract manufacturers located all over the world. These put the highlight on the study of API related requirements, either submitted alone as Drug Master Files (DMFs) or in Dossier of Finished Pharmaceutical Product. The current review study provides the insights of the different pharmaceutical legislations and requirements of an API in Japan, Saudi Arabia and India, which will help the pharmaceutical industries to understand the requirements related to API when registering in the proposed countries.