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Contract Manufacturing Organizations to 2018 - Cost Advantages and Improving Quality Standards Build Confidence and Encourage Foreign Investment in Asian CMOs

s 45

7.2.1 Organization and Personnel 45

7.2.2 Building and Facilities 46

7.2.3 Process Equipment 46

7.2.4 Control of Raw Materials 46

7.2.5 Production and Process Controls 46

7.2.6 Packaging and Labeling 46

7.2.7 Holding and Distribution 46

7.2.8 Key Changes in FDA Guidelines 47

7.3 EMA Guidelines 47

7.3.1 Quality Management 49

7.3.2 Production Activities 49

7.3.3 Buildings and Facilities 49

7.3.4 Process Equipment 50

7.3.5 Materials Management 50

7.3.6 Packaging and Labeling 51

7.3.7 Key Changes in EMA Guidelines 51

7.4 PIC/S 51

8 Contract Manufacturing Organizations to 2018 - Key Aspects of the Upstream and Downstream Processing CMO Industry 53

8.1 Comparison of Upstream Processing and Downstream Processing 53

8.1.1 CMO Market Size for Upstream Processing 54

8.1.2 CMO Market Size for Downstream Processing 55

9 Contract Manufacturing Organizations to 2018 - Key CMO Participants 56

9.1 Catalent Pharma Solutions, Inc. 56

9.2 Lonza Group AG 57

9.3 Royal DSM N.V. 59

9.4 Piramal Healthcare Ltd. 60

9.5 Jubilant Life Sciences 61

9.6 Evonik Industries AG 62

9.7 Patheon Inc. 63

9.8 Fareva Holding 64

9.9 Cambrex 65

9.10 Boehringer Ingelheim 66

10 Contract Manufacturing Organizations to 2018 - Strategic Consolidations within the Global CMO Market 67

10.1 Mergers and Acquisitions 67

10.1.1 Summary of Mergers and Acquisitions 67

10.2 Co-development Deals 68

10.2.1 Summary of Co-development Deals 69

10.3 Licensing Deals 70

10.3.1 Summary of Licensing Deals 71

11 Contract Manufacturing Organizations to 2018 - Appendix 74

11.1 Market Definitions 74

11.2 Abbreviations 74

11.3 Sources 75

11.4 Research Methodology 76

11.4.1 Coverage 76

11.4.2 Secondary Research 76'/>"/>

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