Evaluation of active pharmaceutical ingredient API related queries received by pharmaceutical manufacturers of 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. Not only the submission is important, one also need to take into consideration of different queries received by regulatory authorities related to API. Delay in these queries or improper justification or information may lead to delay or rejection of application of pharmaceutical product. The current research work provides the insights of the different pharmaceutical legislations and requirements of an API as well as different types of queries received by pharmaceutical companies related to API. This study will help Pharmaceutical Manufacturers to get acquainted with different queries and to deal with them prior to minimize any delay or rejection in marketing authorization. newline