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Contract Pharmaceutical Manufacturing, Research and Packaging: Global Markets
Date:9/22/2011

2 (CONTINUED) 29

FACTORS INVOLVED 29

ROLE OF THE PROJECT MANAGER 29

TABLE 13 KEY RESPONSIBILITIES OF PROJECT MANAGERS 30

TECHNOLOGY TRANSFER 30

TABLE 14 TECHNOLOGY TRANSFER STEPS 31

CHAPTER EIGHT: REGULATORY ASPECTS 32

REGULATORY ASPECTS 32

TABLE 15 REGULATED FACTORS OF CMO'S AND CRO'S 33

TABLE 16 TITLE 21 CFR RULES ASSOCIATED WITH CONTRACT

MANUFACTURING 33

TABLE 16 (CONTINUED) 34

TABLE 16 (CONTINUED) 35

WARNING LETTERS 36

TABLE 17 WARNING LETTERS ISSUED TO CONTRACT

MANUFACTURERS, 2010 36

TABLE 18 WARNING LETTERS ISSUED TO CONTRACT

MANUFACTURERS, 2009 37

REGULATORY APPROVALS 37

TABLE 19 REGULATORY APPROVALS OF CONTRACT

MANUFACTURERS AND FACILITIES, JANUARY THROUGH

MARCH, 2011 38

TABLE 20 REGULATORY APPROVALS OF CONTRACT

MANUFACTURERS AND FACILITIES, 2010 38

TABLE 20 (CONTINUED) 39

TABLE 21 REGULATORY APPROVALS OF CONTRACT

MANUFACTURERS AND FACILITIES, 2009 39

TABLE 21 (CONTINUED) 40

CHAPTER NINE: INDUSTRY STRUCTURE FOR NORTH AMERICA 41

MARKET SHARE OF INDUSTRY LEADERS 41

CONTRACT MANUFACTURERS OF BULK DRUGS AND API'S 41

TABLE 22 MARKET SHARE OF CONTRACT MANUFACTURING

COMPANIES PROVIDING BULK DRUGS/API'S, IN NORTH

AMERICA, 2010 (%) 41

TABLE 22 (CONTINUED) 42

FIGURE 1 MARKET SHARE OF CONTRACT MANUFACTURING

COMPANIES PROVIDING BULK DRUGS/API'S, IN NORTH

AMERICA, 2010 (%) 42

CONTRACT MANUFACTURERS OF SOLID-DOSAGE FORMS 42

TABLE 23 MARKET SHARE OF CONTRACT MANUFACTURING

COMPANIES PROVIDING SOLID DOSAGE FORMS, IN NORTH

AMERICA, 2010 (%) 43

FIGURE 2 MARKET SHARE OF CONTRACT MANUFACTURING

COMPANIES PROVIDING SOLID DOSAGE FORMS, IN NORTH

AMERICA, 2010 (%) 43

CONTRACT MANUFACTURERS OF LIQUID DOSAGE FORMS 44

NONSTERILE 44

TABLE 24 MARKET SHARE OF CONTRAC
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