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List of Drug Master Files (DMF) of Excipients submissions by Kerry to the U.S. FDA. Original Data : FDA Website

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01 06201.1 DRYCELL YOGURT FLAVOUR (1)

02 06300.1 DRYCELL ORANGE FLAVOUR (1)

03 20.4554.CP PHA MILK FLAVOUR (2)

04 20.4557.1G PHA MIXED BERRIES FLAVOUR (2)

05 20.4561.1P PHA BLACKCURRANT FLAVOUR (1)

06 20.4561.IP PHA BLACKCURRANT FLAVOUR (1)

07 20.4562.4P PHA ORANGE FLAVOUR (2)

08 20.4563.UL PHA CHERRY FLAVOUR (2)

09 20.4564.2P PHA GRAPE FLAVOUR (2)

10 20.4566.CP PHA STRAWBERRY FLAVOUR (2)

11 20.4568.1G PHA STRAWBERRY FLAVOUR (2)

12 20.4570.3P PHA PASSION FRUIT FLAVOUR (2)

13 20.4571.1V PHA WINTERGREEN FLAVOUR (1)

14 20.4573.5P PHA VANILLA FLAVOUR (2)

15 20.4579.1P PHA MIXED BERRIES FLAVOUR (2)

16 20.4582.2P PHA SOUR CHERRY FLAVOUR (2)

17 30617086 NAT FL MODULATOR (MASKING) FMT r (1)

18 30617089 NAT FL MOD (MOUTHFEEL) FMT ? (1)

19 30619722 NAT FL MOD (SWEET) FMT ? PWD (1)

20 30619798 NAT FL MOD (MASKING) FMT ? SD (1)

21 30620292 NAT FL MODULATOR (MASKING) FMT r PWD (1)

22 30621242 NAT Fl MOD (MASKING) FMT® SD (1)

23 30621251 NAT Fl MOD (MASKING) FMT® SD (1)

24 30623266 NAT FL MODULATOR (MASKING) FMTr PWD (1)

25 30623270 NAT FL MODULATOR (MASKING) FMT r PWD (1)

26 30625750 NAT FL MODULATOR (MASKING) FMTr (1)

27 30625757 NAT FL MOD (MOUTHFEEL) FMT r (1)

28 30625759 NAT FL MOD (MASKING) FMT r SD (1)

29 30625760 NAT FL MODULATOR (MASKING) FMT r PWD (1)

30 30625761 NAT FL MODULATOR (MASKING) FMT r PWD (1)

31 30626205 NAT FL MOD (MASKING) FMT r PWD (1)

32 30627945 NAT FL MODULATOR (MASKING) FMT r PWD (1)

33 30627948 NAT FL MODULATOR (MASKING) FMT r PWD (1)

34 30631914 N&A COOLING FL FMT® (1)

35 30631971 NAT Fl MOD (MASKING) FMT® SD (1)

36 30631976 NAT Fl MOD (MASKING) FMT® SD (1)

37 30632117 NAT FL MOD (MASKING) FMT® (1)

38 30632403 N&A RASPBERRY FL (1)

39 30634656 NAT FL MOD (MASKING) FMT ® SD (1)

40 58.3478.1P PHA ORANGE FLAVOUR (2)

41 58.3514.2P PHA LEMON FLAVOUR (1)

42 58.3520.1P PHA LEMON FLAVOUR (1)

43 58.3536.1P PHA LIME FLAVOUR (1)

44 58.3748.UW PHA PEPPERMINT FLAVOUR (1)

45 58.3754.1P PHA SPEARMINT FLAVOUR (1)

46 58.3964.2P PHA PEPPERMINT FLAVOUR (1)

47 58.4108.UL PHA ORANGE FLAVOUR (1)

48 58.4262.2L PHA LEMON FLAVOUR (1)

49 5X00095 Sheffield Tabletting System DTFD (1)

50 5X00096 Sheffield Tabletting System DTHV (1)

51 5X00138 SHEFFIELD COATING SYSTEM CM (1)

52 5X00139 SHEFFIELD COATING SYSTEM CM (1)

53 5X00140 SHEFFIELD COATING SYSTEM CM (1)

54 5X00149 SHEFFIELD COATING SYSTEM WHITE S (1)

55 5X00161 SHEFFIELD COATING SYSTEM WHITE 03 (1)

56 5X00162 SHEFFIELD COATING SYSTEM CLEAR PG (1)

57 5X00169 SHEFFIELD COATING SYSTEM WHITE PG (1)

58 5X00255 SHEFFCOAT CLEAR GL (1)

59 5X00282 SHEFFCOAT CLEAR 02 (1)

60 700059 - NATURAL AND ARTIFICIAL STRAWBERRY FLAVOR (1)

61 700075 - ARTIFICIAL VANILLA NUT FLAVOR (1)

62 700076 NATURAL & ARTIFICIAL GRAPE FLAVOR (1)

63 700078 ARTIFICIAL CHERRY FLAVOR (1)

64 700355 NATURAL AND ARTIFICIAL ORANGE FLAVOR (1)

65 700432 - NATURAL AND ARTIFICIAL FRUIT PUNCH FLAVOR (1)

66 700437 - NATURAL AND ARTIFICIAL BANANA FLAVOR (1)

67 700439 - NATURAL AND ARTIFICIAL ORANGE PINEAPPLE FLAVOR (1)

68 700443 - NATURAL AND ARTIFICIAL ORANGE FLAVOR (1)

69 700464 - NATURAL AND ARTIFICIAL CHOCOLATE FLAVOR (1)

70 700511 - NATURAL AND ARTIFICIAL PINEAPPLE FLAVOR (1)

71 700512 ARTIFICIAL CHERRY FLAVOR (1)

72 700661 - NATURAL LEMON FLAVOR (1)

73 707972 - NATURAL AND ARTIFICIAL STRAWBERRY FLAVOR (1)

74 708055 EUCALYPTUS OIL 70/75% (1)

75 709039 ARTIFICIAL BUBBLE GUM FLAVOR (1)

76 709319 NATURAL ORANGE FLAVOR WONF (1)

77 709932 N & A TROPICAL PUNCH FL (1)

78 711497 NATURAL LEMON LIME FLAVOR WONF, EXCIPIENT COLORANT FLAVOR (1)

79 715680 - NATURAL AND ARTIFICIAL WINTERGREEN FLAVOR (1)

80 715770 - NATURAL AND ARTIFICIAL CHERRY FLAVOR (1)

81 715787 - NATURAL AND ARTIFICIAL STRAWBERRY FLAVOR (1)

82 715846 - NATURAL LEMON FLAVOR WONF (1)

83 715870 - NATURAL MINT FLAVOR WONF (1)

84 715990 - NATURAL ORANGE FLAVOR WONF (1)

85 716021 - NATURAL AND ARTIFICIAL MIXED BERRY FLAVOR (1)

86 716206 NAT & ART RASPBERRY FLAVOR (1)

87 716252 NATURAL FLAVOR MODULATOR (SWEET) FMT (1)

88 716253 NATURAL FLAVOR MODULATOR (SWEET) FMT (1)

89 9000188 NAT MASKING TYPE FLAVOR (1)

90 ARTIFICIAL COTTON CANDY FLAVOR 0011640 (1)

91 B03373F.1 ORANGE FLAVOUR (1)

92 BIOSET INFUSION, IN CEDEX, FRANCE (1)

93 BLUE RASPBERRY NAT/ARTIFICIAL FLAVOR 707760 (1)

94 BUBBLEGUM ARTIFICIAL FLAVOR 712563 (1)

95 DISINTEQUIK (1)

96 DISINTEQUIK MCC (1)

97 DISINTEQUIK MCC 25 (1)

98 DISINTEQUIK ODT (1)

99 GRAPE NAT/ART FLAVOR 707820 (1)

100 GRAPE SODA ARTIFICIAL FLAVOR MC006124 (1)

101 KERRY FLAVOR SYSTEMS (1)

102 LACTOSE ANHYDROUS NF INHALATION 120MS (1)

103 LACTOSE ANHYDROUS NF INHALATION 40M (1)

104 LACTOSE MONOHYDRATE NF INHALATION 120M (1)

105 LACTOSE MONOHYDRATE NF INHALATION 40M (1)

106 LACTOSE MONOHYDRATE NF INHALATION 80M (1)

107 LUBRITOSE AN (1)

108 LUBRITOSE MANNITOL (1)

109 LUBRITOSE MCC (1)

110 LUBRITOSE SD (1)

111 NAT & ART VANILLA FLAVOR 601444 (1)

112 NAT CHERRY WONF 606007 (1)

113 NATURAL AND ARTIFICIAL RASPBERRY FLAVOR FOR MASKING 650008 (1)

114 NATURAL BANANA FLAVOR WONF 080-0029R LIQUID (1)

115 NATURAL CHERRY WONF 717082 (1)

116 NATURAL SPEARMINT FLAVOR WONF (080-00707) POWDER (1)

117 NATURAL/ARTIFICIAL BUBBLE GUM FLAVOR 0011638 (1)

118 NATURAL/ARTIFICIAL BUBBLE GUM FLAVOR 0011639 (1)

119 NATURAL/ARTIFICIAL CHERRY BERRY TYPE FLAVOR 0014700 (1)

120 SHEFFCOAT COATING SYSTEMS (1)

121 SHEFFIELD BRAND MONOHYDRATE NF INHALATION 120MS (1)

122 STERILE VALIDATION DATA FOR COLUMBUS, OHIO LOCATION (1)

123 STERILITY TESTING OF LARGE VOLUME PARENTERAL SOLUTION (1)

124 STERILIZATION FACILITY (1)

125 STERILIZATION PROCESS VALIDATION FOR USE IN CEDEX, FRANCE (1)

126 STERILIZATION PROCESS VALIDATION IN APPLICATIONS FOR HUMAN AND VETERINARY DRUG PRODUCTS LOCATED IN BRAINE I ALLEUD BELGIUM (1)

127 STERILIZATION PROCESS VALIDATION INFORMATION FOR CARBAPENEM STERILE PRODUCTS LOCATED IN MAHARASHTRA INDIA (1)

128 STERILIZATION PROCESS VALIDATION INFORMATION FOR THE STERILE CEPHALOSPORIN CRYSTALLIZATION PLANT (1)

129 STERILIZATION VALIDATION INFORMATION (1)

130 Sheffcoat Clear (1)

131 Sheffcoat Clear ENT (1)

132 Sheffcoat Clear S (1)

133 Sheffcoat Clear S2 (1)

134 Sheffcoat Clear k (1)

135 Sheffcoat White (1)

136 Sheffcoat White ENT (1)

137 Sheffield Tabletting System ODT (1)

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01 KERRY BIO SCIENCE (2)

02 KERRY BIOFUNCTIONAL INGREDIENTS INC (1)

03 KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE (31)

04 KERRY CANADA INC (4)

05 KERRY INC DBA MASTERTASTE INC (3)

06 KERRY INGREDIENTS AND FLAVOURS (6)

07 KERRY INGREDIENTS AND FLAVOURS DBA MASTERTASTE INC (18)

08 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA (21)

09 MASTERTASTE INC DBA KERRY INC (15)

10 MASTERTASTE INC DBA KERRY INGREDIENTS AND FLAVOURS (22)

11 MASTERTASTE SPA (26)

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01 U.S.A (149)

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01 Active (34)

02 Inactive (115)

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KERRY CANADA INC
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