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New Drug Approvals and Their Contract Manufacture Report- By Size Development Trends, Competitive Landscape And Key Regions 2025

ReportsnReports added Keyword Research Report created by Report Consultant, which offers detailed insights, revenue details, and other information regarding the global market, and the various trends, drivers, restraints, opportunities, and market till 2028. Keyword Report offers detailed information regarding the leading key players operating in the market, their financials, supply chain trends, technological innovations, key developments, apart from future strategies, acquisitions and mergers, and market footprint. Keyword also provides a comparative analysis of the market dynamics pre and post Covid19 outbreak.

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This report is the 11th edition of our long running analysis of the CMO Industry, using NDA approvals as the primary indicator of performance. New Drug Approvals and Their Contract Manufacture (formerly called CMO Scorecard) is critical for benchmarking the performance of the CMO industry and the relative performance of major CMOs. This year’s edition also includes a discussion of Emergency Use Aprrovals for COVID-19.

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Table of Contents
1 Executive Summary
2 Players
3 Technology Briefing
3.1 Innovative Drug Approvals
3.2 Dose Outsourcing of Drug Approvals
4 Trends
5 Industry Analysis
5.1 Introduction
5.2 FDA NDA Approvals Overview
5.3 US vs. EU Approval Performance
5.4 FDA EUA Approvals in 2020 for COVID-19
5.5 FDA: Outsourced Dose Manufacture
5.5.1 Dosage Form Outsourcing
5.6 Special Product Categories
5.7 Outsourcing by Company Market Cap
5.8 CMO Performance
5.9 Outsourced API Approvals
5.10 ANDA Approvals
5.11 What It Means
5.11.1 Increased Innovative Approvals and Number of Outsourced Products
5.11.2 Drivers and Barriers
6 Value Chain
7 Companies
8 Appendix
8.1 Methodology
8.2 Bibliography
8.3 Primary Research – Key Opinion Leaders
8.4 Further Reading
9 About the Authors
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