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

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

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 benchmark their performance against the industry.

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Our research team crunched the numbers on 2016 drug approvals authorized by FDA's CDER, CBER, Fast Track and Breakthrough drugs, and selected EMA approved drugs. For the first time, we are including information on the location of outsourced dose manufacturing facilities.

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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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

Reasons to buy
This report is required reading for -
- CMO executives and strategic decision-makers who seriously follow the global CMO industry, including dose and API manufacturers.
- Bio/Pharma sponsors that buy contract manufacturing services and need to understand contract manufacturing industry drivers.

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This release was published on openPR.