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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.


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.



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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.


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