PharmSource – CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2018 Edition

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Published: April 30, 2018 Report Code: GDPS0020MAR-ST

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This report is the 8th edition of our long running analysis of the CMO Industry, using NDA approvals as the primary indicator of performance. CMO Scorecard is critical for benchmarking the performance of the CMO industry and the relative performance of major CMOs.

Scope

Who should buy this report?

This 43-page report gives important, expert insight you won’t find in any other source. 28 tables and figures throughout the report illustrate major points and trends. This report is required reading for:

• CMO executives who must have deep understanding of the injectables marketplace to make strategic planning and investment decisions.

• Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.

• Private equity investors that need a deeper understanding of the market to identify and value potential investment targets.

3M
Abbvie
ACS Dobfar
Actavis
Adare Pharmaceuticals
Aenova Group
Aesica Pharmaceuticals
Afton Scientific Corp.
Ajinomoto Althea
Ajinomoto Co.
Akorn
Albany Molecular Research Inc.
Alcami
Alkermes
Alliance Medical Products
Almac Group
Alpex Pharma
APL
ARx LLC
ASM Aerosol-Service AG
AstraZeneca
Avara Pharmaceutical Services
Aveva Drug Delivery Systems
B. Braun Melsungen AG
Banner Life Sciences
Bausch & Lomb Pharmaceuticals
Baxter BioPharma Solutions
Baxter International
Bayer Healthcare
BioRamo LLC
BioReliance
Boehringer Ingelheim BioXcellence
Boehringer Ingelheim GmbH
Bristol-Myers Squibb
BSP Pharmaceuticals
Bushu Pharmaceuticals
CAF-DCF
Capsugel
Catalent Pharma Solutions
Cenexi
Cerovene
Chemo
Cipla
Colep
Confab Laboratories
Cook Pharmica LLC
CPL Contract Pharmaceuticals Limited
Debiopharm Research & Manufacturing SA
Delpharm
DPT Laboratories
Ei Inc.
Emergent BioSolutions
Excella Pharma Source
Exela Pharma Sciences
Exelead
Famar
Fareva Holding
Ferndale Labs & Contract Manufacturing
Ferrer Internacional
Fresenius Kabi
Frike Group
Galephar SA
Gedeon Richter
Gilead Sciences
Gland Pharma Limited
GlaxoSmithKline
Glenmark
Grifols
Groupe Panpharma
Halo Pharmaceutical
Hameln Pharmaceuticals GmbH
Holopack Verpackungstechnik GmbH
IDT Biologika GmbH
Importfab Inc.
Instituto Bioclon S.A. de C.V.
Intas Pharmaceuticals Ltd.
James Alexander Corporation
Japan Tobacco Inc.
Jetpharma SA
Jubilant HollisterStier Contract Manufacturing & Services
Kemwell Biopharma
KP Pharmaceutical Technology
Kremers Urban Pharmaceuticals
Laboratoires Théa
Lehigh Valley Technologies Inc.
Lifecore Biomedical
Lonza Netherlands?
LTS Lohmann
LTS Lohmann Therapie-Systeme AG
Lyne Laboratories
Lyophilization Services of New England
Medimmune
Mikart
Mipharm
Mitsubishi Tanabe Pharma Corporation
MonoSol Rx
Mustafa Nevzat Pharmaceuticals
Mylan
Nerviano Medical Sciences
Nexgen Pharma
NextPharma Technologies
Nipro Pharma Corp.
Nordmark Arzneimittel GmbH & Co. KG
Norwich Pharma Services
Nova Laboratories Ltd
Nuvo Research
Orion Corporation
Pari Pharma
Patheon
PCI Pharma Services
Perrigo
Pfizer
Pharmaceutical Manufacturing Research Services Inc.
Pharmaceutics International
Pharmaceutics International Inc
Pharmascience Inc.
Pierre Fabre
Pierrel SpA
Pillar5 Pharma Inc.
Piramal Pharma Solutions
Porton Biopharma Limited
QS Pharma
Rechon Life Science
Recipharm
Recro Pharma Inc.
Renaissance
Rentschler Biopharma SE
Rivopharm S.A.
Rosemont Pharmaceuticals
Rottendorf
Rottendorf Pharma GmbH
Sanico NV.
Sanofi
Sanquin Blood Supply Foundation
Siegfried
Sintetica
Sirton Pharmaceuticals SpA
Steri-pharma LLC
Sterigenics
Swedish Orphan Biovitrum AB
Synerlab Group
Tapemark
Teligent
The Ritedose Corporation
Tris Pharma
Unither Pharmaceuticals
University of Iowa Pharmaceuticals
UPM Pharmaceuticals
Valeant Pharmaceuticals International
Vectura
Vetter Pharma International
Vifor Pharma
Wockhardt Contract Manufacturing
Woodfield Pharmaceutical
Zydus Cadila

Table of Contents

1. Executive Summary 5

2. Introduction 6

3. NDA Approvals Overview 6

4. US Versus EU Approval Performance 8

5. Outsourced Dose Manufacture 9

6. Special Product Categories 13

7. Outsourcing by Global Bio/Pharma Companies 17

8. CMO Performance 19

9. Outsourced API Approvals 21

10. What It Means 24

11. Notes on Methodology 25

12. Appendix 27

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