Indian Pharmaceutical Industry - Biotechnology, Healthcare and Life Sciences Publishing

Home > Browse Reports > Pharmaceutical > Indian Pharmaceutical Industry

Report Description

Indian Pharmaceutical Industry
Publication Date: 15-OCT-05
Pages: 183
Study: TMRINP03
Format/Price: PDF document / $999.00

Description:

The purpose of this TriMark Publications study is to describe the specific segment of the pharmaceutical market sector called the Indian pharmaceutical industry. This sector includes all of the generally-accepted pharmaceutical manufacturing activities that are currently used today, including the bulk drug industry, formulations and major therapeutic segments. It examines these clinical supplies as utilized in hospitals, clinics and doctor's offices. The principal objectives of this analysis are to: 1) identify viable technology drivers through a comprehensive look at various platform technologies for the Indian pharmaceutical industry; 2) obtain a complete understanding of the Indian pharmaceutical industry practices from its basic principles to its applications; 3) discover feasible market opportunities via an identification of high-growth applications in different areas of the Indian pharmaceutical industry, with a focus on the biggest and expanding markets for the Indian pharmaceutical industry; 4) focus on global industry development through an in-depth analysis of the major world markets for pharmaceutical manufacturing, including forecasts for growth; and 5) establish the essentials of the Indian pharmaceutical market including definitions, processes and trends.

Table of Contents:

1. Overview 9
1.1 Statement of Report 9
1.2 Scope of the Report 10
1.3 Methodology 10
1.4 Executive Summary 10
2. Introduction 13
2.1 India's Major Pharma Export Destinations 13
3. The Indian Market 18
3.1 Projected Market Size 18
3.2 Present Core Competence 18
3.3 Key Market Intelligence 18
3.4 Analysis of Market 20
3.5 Indian Biotechnology Industry-A Snapshot for Investors 21
4. Characteristics of the Indian Pharmaceutical Industry 22
4.1 Profitability 22
4.2 Location 22
4.3 Segmentation of the Indian Pharmaceutical Industry 22
4.3.1 Bulk Drug Industry 22
4.3.1.1 Production and Exports of Drugs and Pharmaceuticals 26
4.3.1.2 Projections for Bulk Drugs and Formulations-1997-98 to 2001-02 27
4.3.2 Formulations 28
4.4 Major Therapeutic Segments 29
5. Key Players in the Indian Pharmaceutical Industry 32
5.1 Multinational Corporations (MNC's) Playing a Critical Role 32
5.1.1 Glaxo 32
5.1.1.1 Performance Summary 36
5.1.1.2 Performance Drivers in 2004 36
5.1.2 Pfizer India 37
5.1.2.1 Performance Summary 41
5.1.2.2 Performance Drivers in 2005 41
5.1.2.3 Analyst Expectations 43
5.1.3 Aventis Pharma 43
5.1.3.1 Performance Summary 46
5.1.3.2 Performance Drivers in 2QCY04 46
5.1.3.3 Analyst Forecast 47
5.1.4 Novartis India 47
5.1.4.1 Performance Summary 50
5.1.4.2 Performance Drivers in 3QFY05 51
5.1.4.3 Analyst Expectations 52
5.2 Key Indian Players 52
5.2.1 Ranbaxy 52
5.2.1.1 Analyses 53
5.2.1.2 Performance Drivers in 2004 54
5.2.2 Dr. Reddy's Labs (DRL) 57
5.2.2.1 Performance Summary 60
5.2.2.2 Performance Drivers 61
5.2.3 Cipla 62
5.2.3.1 Performance Summary 65
5.2.3.2 Performance Drivers in 3QFY05 66
5.2.4 Sun Pharma 67
5.2.4.1 Performance Summary 70
5.2.4.2 Performance Drivers in 2QFY05 70
5.2.4.3 Analyst Expectations 71
5.2.5 Abbott India Limited (Knol) 71
5.2.6 Wockhardt 74
5.2.6.1 Performance Summary 78
5.2.6.2 Peformance Drivers in 2004 78
5.2.7 Nicholas Piramal India 80
5.2.8 Lupin 80
6. Strategic Groups 81
7. Critical Success Factors (CSF) of the Industry 82
7.1 Research and Development 82
7.2 Production 82
7.3 Marketing, Sales and Distribution 82
7.4 Operational Efficiency 83
7.5 Alliances 83
7.6 Pre 2005 CSFs-Formulations 83
7.6.1 New Product Launches 83
7.6.2 Therapeutic Coverage 83
7.6.3 Sales and Distribution Network 83
7.6.4 Strong Brands 84
7.6.5 Exports 84
7.6.6 Critical Mass 84
7.7 Pre 2005 CSFs-Bulk Drugs 84
7.7.1 Low Cost Structure 84
7.7.2 Internationally Approved Manufacturing Facilities 85
7.7.3 Speedy Launches 85
7.8 Post 2005 CSFs-The Most Critical 85
7.8.1 Basic R&D 85
7.8.2 Applied Research and Development 85
7.8.3 Process Research or Reverse Engineering 85
7.8.4 Analogue or Discovery Research 85
7.9 Biotechnology Research 85
7.9.1 Biotech, Bio-Generics and Vaccines 86
7.9.2 Cost Advantage of Indian Biotech Industry 86
7.9.3 Challenges Facing the Indian Bio-Generics 86
7.9.4 Vaccine Manufacturing 86
7.9.5 Vaccine R&D 86
7.10 Bringing out a Generic Drug 86
7.11 New Drug Delivery System (NDDS) Research 87
7.12 Indian Council of Medical Research-Innovative New Products 87
7.13 Non-ICMR Vaccines 87
8. A Farsighted Strategy in Competition and Cooperation 88
8.1 NCE/Proprietary Drugs 88
8.2 Marketing Alliances with International Players 88
8.3 R&D in India 88
8.4 Investment and R&D 89
8.5 Profitability 91
9. Indian Pharma Exports 92
10. Policies and Regulations 94
10.1 Indian Patents Act (IPA) 1970 94
10.2 DPCO (Drug Price Control Order)-1970 94
10.3 GATT and WTO 94
10.4 Implications of the WTO 95
10.4.1 On Prices of Drugs 95
10.4.2 On R&D 95
10.5 Intellectual Property Rights (IPR) 95
11. Changing Scenario of Product Patent Regime 96
11.1 Critic's View 96
11.2 Price Escalation 96
11.3 MNC Dominance 98
11.4 R&D Expenditure 98
11.5 Technology 98
11.6 Conclusion 99
12. Laws Pertaining to Manufacture and Sale of Drugs in India 100
12.1 The Drugs and Cosmetics Act, 1940 100
12.2 The Pharmacy Act, 1948 100
12.2.1 State Pharmacy Councils 101
12.2.2 Registration of Pharmacists 101
12.3 The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 101
12.4 The Narcotic Drugs and Psychotropic Substances Act, 1985 101
12.4.1 State Pharmacy Councils 102
12.4.2 Registration of Pharmacists 102
13. Marketing and Distribution in the Pharmaceutical Industry 103
13.1 In-clinic Media 103
13.2 Outdoor Media 103
13.3 Electronic Media 103
14. The Changing External Environment 112
15. Porters Five Forces Model 113
15.1 Threat of New Entrants 113
15.2 Intensity of Competition 113
15.3 Threat of Substitutes 114
15.4 Bargaining Power of Buyers 114
15.5 Bargaining Power of Suppliers 114
16. Future Outlook for the Indian Pharmaceutical Industry 115
16.1 Government Policy-Update 115
16.1.1 Budget Proposals 2005-06 115
17. Emerging Trends 116
18. India-The Clinical Trial Destination 117
18.1 Clinical Trials - The India Opportunity 117
18.2 Clinical Research Organizations (CRO) 117
18.3 Indian Companies in Collaborative Manufacturing Partnerships with Pharmaceutical Multinationals 120
18.4 Product Patents will Transform Traditional Medicine 120
19. Risks-Weaknesses and Threats-Faced by Indian Industry 121
19.1 Global Pharmaceutical Market-India's Strengths 121
19.2 Production 121
19.3 Quality 122
19.4 Research and Development 122
19.5 Opportunities for the Future 123
19.6 Conclusion 123
20. Intellectual Property and Access to Medicines 124
20.1 Data Exclusivity 124
20.2 Interpretation of Product Patent Applicability 124
20.3 Mailbox Applications 124
20.4 Fears over Price Escalation 124
20.5 Quality 125
20.6 Availability 126
21. Evolving Indian Drug Research and Development 127
21.1 Composition of R&D Expenditure 127
21.2 A Shift in Focus is the Need of the Hour 128
21.3 Cost Advantages of Indian Firms 128
21.4 Achievements of in-House R&D Units Funded by the Indian Department of Scientific and Industrial Research during 2003 to 2004 133
22. Case of a Leading Indian Firm-Ranbaxy Laboratories 134
22.1 History 134
22.2 R&D is the Integrating Factor 134
22.3 Ranbaxy's Successful Report Card 135
22.4 Why has Ranbaxy been this Successful? 135
22.5 The Evolution of Ranbaxy-Time Line Analysis 135
22.5.1 1970 to Early 1980s 135
22.5.2 Early 1980s to 1994 136
22.5.3 1994 to 1997 137
22.5.4 1997 Onwards 137
22.6 Leveraging Mergers and Alliances 138
22.7 Research and Development 138
22.8 Alliances for Entry into U.S. and European Markets 139
22.9 Growth of Market Share and Product Portfolio 139
22.10 Creating Value through Functional Strategies 140
22.11 Marketing 142
22.12 Relationship Marketing 142
22.13 Co-Marketing 142
22.14 Sales Strength 142
22.15 Brand Recognition 143
22.16 Ranbaxy's Product Strategy 143
22.17 Ranbaxy R&D Strategy 143
22.18 Research Strategy 143
22.19 Ranbaxy's Human Resources Strategy 143
22.20 Information Technology 144
22.21 Revenue Model for a Pharmaceutical Company 144
23. Strategic Options for Pharmaceutical Firms 145
23.1 Invest in Research and Development Capabilities 146
23.2 Grow a Wide Product Portfolio 146
23.2.1 Growth through Mergers and Acquisitions 146
23.2.2 Growth through Brand Acquisition 146
23.2.3 Growth through Licensing Agreements 146
23.3 Remain a Generics Player 146
24. How to Build Sustainable Competitive Advantage 148
24.1 Product Portfolio Management 148
24.2 Integrated Healthcare Company 148
24.3 Distribution 148
24.4 Disease Management/Service Provider 148
24.5 Clinical Test Centers 148
24.6 Healthcare Funding Systems 148
24.7 Re-Engineering 149
24.8 Outsourcing Services 149
Appendix 150
1. Requirements and Guidelines for Permission to Import and/or Manufacture of New Drugs for Sale or to Undertake Clinical Trials 150
1.1 Application for Permission 150
2. Clinical Trial 151
2.1 Approval for Clinical Trial 151
2.2 Responsibilities of Sponsor 152
2.3 Responsibilities of the Investigator(s) 152
2.4 Informed Consent 152
2.5 Responsibilities of the Ethics Committee 152
2.6 Human Pharmacology (Phase I) 153
2.7 Therapeutic Exploratory Trials (Phase II) 153
2.8 Therapeutic Confirmatory Trials (Phase III) 153
2.9 Post Marketing Trials (Phase IV) 154
3. Studies in Special Populations 154
3.1 Geriatrics 154
3.2 Pediatrics 154
3.3 Pregnant or Nursing Women 155
3.4 Post-Marketing Surveillance 155
3.5 Special Studies: Bioavailability/Bioequivalence Studies 156
4. Data to be Submitted along with the Application to Conduct Clinical Trials/Import/Manufacture of New Drugs for Marketing in India 157
5. Data Required to be Submitted by an Applicant for Grant of Permission to Import and/or Manufacture a New Drug Already Approved in India 159
6. Structure, Contents and Format for Clinical Study Reports 159
7. Animal Toxicology (Non-Clinical Toxicity Studies) 160
7.1 General Principles 160
7.1.1 Systemic Toxicity Studies 161
7.1.1.1 Single-dose Toxicity Studies 161
7.1.1.2 Repeated-dose Systemic Toxicity Studies 161
7.1.2 Male Fertility Study 162
7.1.3 Female Reproduction and Developmental Toxicity Studies 163
7.1.3.1 Female Fertility Study (Segment I) 163
7.1.3.2 Teratogenicity Study (Segment II) 163
7.1.3.3 Perinatal Study (Segment III) 163
7.1.4 Local toxicity 164
7.1.5 Allergenicity/Hypersensitivity 165
7.1.6 Genotoxicity 166
7.1.7 Carcinogenicity 167
8. Non-clinical Toxicity Testing and Safety Evaluation Data of an Ind Needed for the Conduct of Different Phases of Clinical Trials 170
8.1 For Phase I Clinical Trials 170
8.2 For Phase II Clinical Trials 170
8.3 In vivo Genotoxicity Tests 170
8.4 For Phase III Clinical Trials 170
8.5 For Phase IV Clinical Trials 171
9. Animal Pharmacology 171
9.1 General Principles 171
9.1.1 Specific Pharmacological Actions 171
9.1.2 General Pharmacological Actions 171
9.1.2.1 Essential Safety Pharmacology 171
9.1.3 Follow-up and Supplemental Safety Pharmacology Studies 171
9.1.3.1 Follow-up Studies for Essential Safety Pharmacology 172
9.1.3.2 Supplemental Safety Pharmacology Studies 172
9.1.4 Conditions under Which Safety Pharmacology Studies are not Necessary 172
9.1.5 Timing of Safety Pharmacology Studies in Relation to Clinical Development 172
9.1.5.1 Prior to First Administration in Humans 172
9.1.5.2 During Clinical Development 172
9.1.5.3 Before Applying for Marketing Approval 172
9.1.6 Application of Good Laboratory Practices (GLP) 173
10. Informed Consent 173
10.1 Checklist for Study Subject's Informed Consent Documents 173
10.1.1 Essential Elements 173
10.1.2 Additional Elements, which may be Required 173
10.2 Format of Informed Consent Form for Subjects Participating in a Clinical Trial 174
11. Fixed Dose Combinations (FDCs) 175
12. Undertaking by the Investigator 175
13. Ethics Committee 176
13.1 Number of Persons 176
13.2 Format for Approval of Ethics Committee 177
14. Stability Testing of New Drugs 177
15. Stability Testing of New Drug Substances and Formulations 178
16. Contents of the Proposed Protocol for Conducting Clinical Trials 179
16.1 Title Page 179
16.2 Table of Contents 179
17. Data Elements for Reporting Serious Adverse Events Occurring in a Clinical Trial 181
INDEX OF FIGURES
Figure 1: Projected Analysis of Indian Pharmaceutical and Biotechnology Industry 21
Figure 2: Production Trends of Pharmaceuticals in India 29
Figure 3: Pfizer India's Performance 42
Figure 4: Sales Trends of Aventis Pharma 47
Figure 5: Strategic Group Mapping 81
Figure 6: Porter's Five Forces Model Applied 113
Figure 7: Ranbaxy's Focus during 1970 to Early 1980s 136
Figure 8: Ranbaxy's Focus during Early 1980s to 1994 136
Figure 9: Ranbaxy's Focus during 1994 to 1997 137
Figure 10: Ranbaxy's Focus from 1997 Onwards 138
Figure 11: Value Chain of Ranbaxy 141
Figure 12: Strategic Options Available for Pharmaceutical Firms 145
INDEX OF TABLES
Table 1: India's Major Pharma Exports to Various Destinations for 2000 to 2001 13
Table 2: Indian Global Generics Market Size from 2003 to 2010 15
Table 3: Present Core Competence of Indian Pharmaceutical Industry 20
Table 4: Data on Production of Selected Bulk Drugs of Selected Companies in the Organized Sector During 1999-2000, 2000-01, 2001-02, 2002-03 and 2003-04 23
Table 5: Indian Production of Bulk Drugs and Formulations 1980 to 2000 26
Table 6: Indian Production of Bulk Drugs 26
Table 7: India's Global Exports of Bulk Drugs and Formulations 27
Table 8: Bulk Drug Formulations 27
Table 9: Production-Formulations 28
Table 10: Global Pharma-Growth Patterns 29
Table 11: Leading Therapeutic Segments 30
Table 12: Market Share of Major Therapeutic Segments 31
Table 13: Leading Brands in Each Category 31
Table 14: Market Growth Rates for 2003 and 2004 31
Table 15: Key Players and their Characteristics 32
Table 16: Glaxo SmithKline (Price History as on March 16, 2005) 33
Table 17: Glaxo SmithKline Interim Results 33
Table 18: Glaxo SmithKline Financials-Equity Share Data 34
Table 19: Glaxo SmithKline Income Data 34
Table 20: Glaxo SmithKline Balance Sheet Data 35
Table 21: Glaxo SmithKline Share Holders 35
Table 22: Glaxo SmithKline Capacity Data 35
Table 23: Glaxo SmithKline Table Raw Materials 36
Table 24: Glaxo SmithKline Performance Summary 36
Table 25: Glaxo SmithKline Segmental Snapshot 37
Table 26: Glaxo SmithKline Cost Analysis 37
Table 27: Pfizer India Price History (as on March 16, 2005) 38
Table 28: Pfizer India Interim Results 38
Table 29: Financials-Pfizer India Equity Share Data 39
Table 30: Pfizer India Income Data 39
Table 31: Pfizer India Balance Sheet Data 40
Table 32: Pfizer India Share Holding 40
Table 33: Pfizer India Capacity Data 40
Table 34: Pfizer India Raw Materials Data 41
Table 35: Pfizer India Performance Summary 41
Table 36: Pfizer India Performance Drivers in 2005 42
Table 37: Pfizer India Cost Structure 42
Table 38: Aventis Pharma Price History (as on March 6, 2005) 43
Table 39: Aventis Pharma Interim Results 43
Table 40: Aventis Pharma Financials-Equity Share Data 44
Table 41: Aventis Pharma Income Data 44
Table 42: Aventis Pharma Balance Sheet Data 45
Table 43: Aventis Pharma Share Holding 45
Table 44: Aventis Pharma Capacity Data 45
Table 45: Aventis Pharma Performance Summary 46
Table 46: Aventis Pharma Cost Analysis 46
Table 47: Novartis India Price History (as on March 16, 2005) 47
Table 48: Novartis India Interim Results 48
Table 49: Novartis India Financials-Equity Share Data 48
Table 50: Novartis India Income Data 49
Table 51: Novartis India Balance Sheet Data 49
Table 52: Novartis India Share Holding 50
Table 53: Novartis India Capacity Data 50
Table 54: Novartis India Raw Material Data 50
Table 55: Novartis India Performance Summary 50
Table 56: Novartis India Performance Drivers in 3QFY05 51
Table 57: Novartis India Cost Analysis 51
Table 58: Ranbaxy Price History (Price History as on March 16, 2005) 52
Table 59: Ranbaxy Interim History 53
Table 60: Ranbaxy Financial Performance-A Snapshot 53
Table 61: Ranbaxy Financials-Equity Share Data 55
Table 62: Ranbaxy Income Data 55
Table 63: Ranbaxy Balance Sheet Data 56
Table 64: Ranbaxy Shareholding 56
Table 65: Ranbaxy Capacity Data 56
Table 66: Ranbaxy Raw Materials Data 57
Table 67: Dr. Reddy's Labs Price History as on March 16, 2005 57
Table 68: Dr. Reddy's Labs Interim Results 58
Table 69: Dr. Reddy's Labs Financials-Equity Share Data 58
Table 70: Dr. Reddy's Labs Income Data 59
Table 71: Dr. Reddy's Labs Balance Sheet Data 59
Table 72: Dr. Reddy's Labs Share Holding 60
Table 73: Dr. Reddy's Labs Capacity Data 60
Table 74: Dr. Reddy's Labs Raw Materials Data 60
Table 75: Dr. Reddy's Labs Performance Summary 60
Table 76: Dr. Reddy's Labs Segmental Revenues* 61
Table 77: Dr. Reddy's Labs Cost Break-up 62
Table 78: Cipla Price History (as on March 16, 2005) 62
Table 79: Cipla Interim Results 63
Table 80: Cipla Equity Financials-Share Data 63
Table 81: Cipla Income Data 64
Table 82: Cipla Balance Sheet Data 64
Table 83: Cipla Capacity Data 65
Table 84: Cipla Raw Materials Data 65
Table 85: Cipla Performance Summary 65
Table 86: Cipla Business Snapshot 66
Table 87: Cipla Cost Analysis 66
Table 88: Sun Pharma Price History (as on March 16, 2005) 67
Table 89: Sun Pharma Interim Results 67
Table 90: Sun Pharma Financials-Equity Share Data 68
Table 91: Sun Pharma Income Data 68
Table 92: Sun Pharma Balance Sheet Data 69
Table 93: Sun Pharma Share Holding 69
Table 94: Sun Pharma Capacity Data 69
Table 95: Sun Pharma Raw Materials Data 70
Table 96: Sun Pharma Performance Summary 70
Table 97: Sun Pharma Sales Break-up 71
Table 98: Abbott India Limited (Knol) (Price History as on March 16, 2005) 71
Table 99: Abbott India Limited (Knol) Interim Results 72
Table 100: Abbott India Limited (Knol) Financials Equity Share Data 72
Table 101: Abbott India Limited (Knol) Income Data 73
Table 102: Abbott India Limited (Knol) Balance Sheet Data 73
Table 103: Abbott India Limited (Knol) Share Holding 74
Table 104: Abbott India Limited (Knol) Capacity Data 74
Table 105: Abbott India Limited (Knol) Raw Materials Data 74
Table 106: Wockhardt Price History (as on March 16, 2005) 75
Table 107: Wockhardt Interim Results 75
Table 108: Wockhardt Financials-Equity Share 76
Table 109: Wockhardt Income Data 76
Table 110: Wockhardt Balance Sheet Data 77
Table 111: Wockhardt Share Holding 77
Table 112: Wockhardt Capacity Data 77
Table 113: Wockhardt Raw Material Data 78
Table 114: Wockhardt Performance Summary 78
Table 115: Wockhardt Geographical Mix 79
Table 116: Wokhardt Business Mix 79
Table 117: Number of Brand Acquisitions 84
Table 118: R&D Investment of Indian Pharmaceutical Companies 88
Table 119: Investment in Indian Pharmaceutical Industry 89
Table 120: R&D* Expenditure by Indian Pharmaceutical Companies 90
Table 121: Profitability Ratios in Pharmaceutical Industry (CMIE Calculations) 91
Table 122: Indian Pharma Exports 92
Table 123: Top 15 Countries of Exports of Drugs and Pharmaceuticals from India during 2002 to 2003 with Comparative Figures for Previous Years 92
Table 124: CHEMEXCIL's Region-wise Export Statistics of Drugs, Pharmaceuticals and Fine Chemicals for 2000-01, 2001-02 and 2002-03 93
Table 125: India's Export of Drugs and Pharmaceutical Products through Major Ports 93
Table 126: Drugs under DPCO and the Share of the Industry 94
Table 127: Indian Patent Regime in Place 96
Table 128: Drugs Control Administration by the Central Drug Standard Control Organization under the Aegis of Directorate General of Health Services of the Ministry of Health and Family Welfare of the Government of India 102
Table 129: List of Drugs Approved During 1999 to 2004 104
Table 130: New Drugs Approved from August 2004 to February 2005 108
Table 131: List of Drugs Prohibited for Manufacture and Sale through Gazette Notifications under Section 26A of Drugs and Cosmetics Act 1940 by the Ministry of Health and Family Welfare 110
Table 132: Other Drugs Prohibited for Manufacture, Sale and Distribution 111
Table 133: Projected Growth of Indian Clinical Research Industry 117
Table 134: Exports of Drugs, Pharmaceuticals and Fine Chemicals 122
Table 135: R&D Spend of Leading Indian Companies 127
Table 136: Industry-wide Change in R&D Spend-Reported R&D Expenditure by Indian Pharmaceutical Firms (1991 to 2000) 129
Table 137: Ongoing Projects of Drugs and Pharmaceutical Research Program 130
Table 138: Chemical and Allied Industries 133
Table 139: Ranbaxy's IT Initiatives 144
Table 140: Typical Price Drops after a Drug Goes Off Patent 147
Table 141: Animal Toxicity Requirements for Clinical Trials and Marketing of a New Drug 168
Table 142: Local Toxicity Studies 168
Table 143: Special Toxicity Studies 168
Table 144: Number of Animals Required for Repeated-Dose Toxicity Studies 169
Table 145: Laboratory Parameters to be Included in Toxicity Studies 169
Table 146: Urinalysis Parameters 169
Table 147: Blood Biochemical Parameters 169
Table 148: Gross and Microscopic Pathology 169
Table 149: Informed Consent Form to Participate in a Clinical Trial 174
Table 150: Study Conditions for Drug Substances and Formulations Intended to be Stored under General Conditions 178
Table 151: Study Conditions for Drug Substances and Formulations Intended to be Stored in a Refrigerator 178
Table 152: Study Conditions for Drug Substances and Formulations Intended for Storage 179

Home | Reports | Database Tables | Conferences | Contact Us