PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION

  • Dhruvi H. Patel Ramanbhai Patel College of Pharmacy, CHARUSAT Campus, Changa- 388 001, Gujarat, India.
  • Jitendra Kumar Badjatya Umedica Laboratories Pvt. Ltd., Vapi, Gujarat, India.
  • Amit A Patel Ramanbhai Patel College of Pharmacy, CHARUSAT Campus, Changa- 388 001, Gujarat, India.

Abstract

The present article summarizes & simplify the marketing application requirements i.e. the critical aspects of
marketing application in different CTD using countries, Process to prepare and review the requirements for CMC
section (Chemistry manufacturing & Control) for filing an application in regulated market. Study shows the
compilation of dossier as per CTD format with minimum errors during filing. The focus is on the application filing &
Query part that may come after submission & during approval process. So one has to focus on the requirements of
dossiers with minimal queries & study the probable queries that may arise after filing an application to regulated
countries. Once approved, the applicant can market the safe, effective, stable & quality generic drug product with low
cost to the public. The complete marketing application is based as per CTD format gives understanding of critical
aspects of Marketing Application and better understanding of dossier filing.
 

Keywords: CTD, CMC, Module, ICH, Dossier, Active Pharmaceutical Ingredients (API), Certificate of Analysis (COA).

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Author Biographies

Dhruvi H. Patel, Ramanbhai Patel College of Pharmacy, CHARUSAT Campus, Changa- 388 001, Gujarat, India.

Ramanbhai Patel College of Pharmacy, CHARUSAT Campus, Changa- 388 001, Gujarat, India.

Jitendra Kumar Badjatya, Umedica Laboratories Pvt. Ltd., Vapi, Gujarat, India.

Umedica Laboratories Pvt. Ltd., Vapi, Gujarat, India.

Amit A Patel, Ramanbhai Patel College of Pharmacy, CHARUSAT Campus, Changa- 388 001, Gujarat, India.

Ramanbhai Patel College of Pharmacy, CHARUSAT Campus, Changa- 388 001, Gujarat, India.

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How to Cite
Patel, D. H., J. K. Badjatya, and A. A. Patel. “PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 2, June 2017, pp. 1-12, doi:10.22270/ijdra.v5i2.196.