ISSN : 0975-9492


Open Access

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Title : Registration process of API in U.S and Europe along with comparision of USDMF and EUDMF
Authors : Nupur Sunil Bhargava, Mr. Darshil Bharatbhai Shah, Dr. Dilip Girishbhai Maheshwari
Keywords : API, DMF, Submission, Drug substance
Issue Date : March 2015
Abstract :
APIs have been called bulk actives, bulk pharmaceutical chemicals, and even bulk chemicals. No matter what they are called, these materials are critical to the drug approval process in all regions of the world. Since APIs are the compounds that actually provide the activity and effectiveness of all drugs, they are subject to a significant amount of review during the filing and approval processes. In order to obtain a marketing authorisation for a drug product the applicant has to show evidence of efficacy, safety and quality of the drug product. To assure this, appropriate documentation on the active substance including the manufacturing of the active substance has to be submitted to the competent authority. Different regions have adopted different procedure for regulatory filing for API, in U.S it as done as per DMF procedure while in Europe it is done by CEP and ASMF procedure.
Page(s) : 486-494
ISSN : 0975-9492
Source : Vol. 6, No.3