Home | Articles
Published on:July 2019
Indian Journal of Pharmaceutical Education and Research, 2019; 53(3):414-420
Review Article | doi:10.5530/ijper.53.3.74

Chemistry, Manufacturing and Control (CMC) Evaluations of ANDA Submission in the USA


Authors and affiliation (s):

Akshatha G, Anoop Narayanan V*, Sandeep D S, Narayana Charyulu R

Department of Pharmaceutics, Nitte Gulabi Shetty Memorial (NGSM) Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Paneer, Mangalore, Karnataka, INDIA.

Abstract:

Background: The Abbreviated New Drug Application commonly referred as ANDA is an application that contains data submitted to US FDA for the review and prospective marketing authorization of generic drugs. The conduct of the reviewing of the application is done by the Division of Filing Review (DFR), Office of Regulatory Operations (ORO) in the Office of Generic Drugs (OGD). The format of ANDA: USFDA recommends the submission of ANDA applications as per ICH Common Technical Document (CTD) format. Module 3: Module 3 of CTD contains chemistry, manufacturing and control (CMC) information including all the supporting details verifying that was summarised in section 2.3 which is the quality overall summary. Evaluation of ANDA: For the evaluation of an Abbreviated New Drug Application in the US, its Office of Generic Drugs (OGD) has developed a Question-based Review (QbR) for its CMC section which is mainly focussed on the critical quality attributes. Conclusion: The implementation of Questionbased Review programme is yielding good improvements in FDA’s division of Office of Generic Drugs (OGD), i.e., by advancing the review pattern of the ANDA CMC section without compromising quality and efficacy for the indication of the generic product.

Key words: USFDA, Question-based Review, Chemistry manufacture and control, CTD, Module 3.

 

Articles in PDF, ePUB and Full text are attached to this page. In order to download, print or access these formats you must be logged in.
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.
9 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.




 

Impact Factor

IJPER - An Official Publication of Association of Pharmaceutical Teachers of India is pleased to announce continued growth in the 2019 Release of Journal Citation Reports (source: 2018 Web of Science Data).

 

Impact Factor® as reported in the 2018 Journal Citation Reports® (Clarivate Analytics, 2019): 0.425

User login

CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.
1 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

DOI HISTORY

IJPER uses reference linking service using Digital Object Identifiers (DOI) by Crossref. Articles from the year 2013 are being assigned DOIs for its permanent URLs