PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2017 Edition

Market: Pharmaceuticals and Healthcare

Global, 42 pages report, published by GlobalData

Report ThumbnailApril-2017
PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2017 Edition

Summary

Where’s your place in the CMO hierarchy?

Find out in the CMO industry’s authoritative analysis of manufacturing of NDA approvals. This CMO scorecard was compiled through hundreds of professional hours of research and analysis, and is presented in a 40-page report with over 30 graphs and tables. Only CMO Scorecard enables the CMO industry to benchmark its performance over time, and CMOs to benc

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  • Figure 1 NDA Approvals 2007-2016
  • Figure 2 NDA Approvals by Sponsor Type 2007-2016
  • Figure 3 EMA Approvals 2012-2016
  • Figure 4 Share of NDA Approvals Outsourced 2007-2016
  • Figure 5 Absolute Numbers of Outsourced NDA Approvals 2007-2016
  • Figure 6 Outsourcing of Small and Large Molecule API NMEs 2007-2016
  • Figure 7 Outsourcing of NME Approvals by Sponsor Type
  • Figure 8 Outsourcing of Non-NME NDA Approvals by Sponsor Type
  • Figure 9 Outsourcing of Orphan NMEs 2007-2016
  • Figure 10 Breakthrough NME Drug Approv
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  • 1.1 List of Tables
  • Table 1 Approvals by Dosage Form
  • Table 2 Outsourced NDA Approvals by Dosage Form
  • Table 3 Outsourcing by Sponsor Type and FDA Approval Type 2011-2016
  • Table 4 Dose CMOs Receiving Approvals in 2016
  • Table 5 API CMOs Receiving NME Approvals in 2016
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  • 1 Table of Contents
  • Executive Summary
  • Introduction
  • NDA Approvals Overview
  • US vs. EU Approval Performance
  • Outsourced Dose Manufacture
  • Special Product Categories
  • Outsourcing by Global Bio/Pharma Companies
  • Outsourced Dose Form
  • Manufacture by Country
  • CMO Performance
  • Outsourced API Approvals
  • What It Means
  • Note on Methodology
  • Appendix
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