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

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01 ARLACEL P135 (PEG 30 DIPOLYHYDROXYSTEARATE) (1)

02 CRODALAN AWS (1)

03 CRODAMOL DA (DIISOPROPYL ADIPATE) (1)

04 CRODAMOL SE (REFINED DIETHYL SEBACATE) (1)

05 CRODESTA SL 40E (SUCROSE COCOATE) (1)

06 GLYCERYL DIOLEATE (1)

07 OMEGA-3-ACID TRIGLYCERIDES PH EUR (1)

08 SUPER REFINED ARLASOLVE DMI (DIMETHYL ISOSORBIDE) (1)

09 SUPER REFINED CRODAMOL IPM UP LQ (JP) (1)

10 SUPER REFINED NOVOL NF (OLEYL ALCOHOL) (1)

11 SUPER REFINED OLEIC ACID NF (1)

12 SUPER REFINED PEANUT OIL NF (1)

13 SUPER REFINED POLYETHYLENE GLYCOL 300 NF (1)

14 SUPER REFINED POLYETHYLENE GLYCOL 400 NF (1)

15 SUPER REFINED SESAME OIL (1)

16 SUPER REFINED SOYBEAN OIL (1)

17 SUPER REFINEDr TWEEN 80 LLQ-(MH) (1)

18 TWEEN 80 HP-LQ-(MH) (2)

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01 CRODA EUROPE LTD (3)

02 CRODA INC (13)

03 CRODA JAPAN KK (3)

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01 U.S.A (13)

02 United Kingdom (6)

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01 Active (4)

02 Inactive (15)

URL Supplier Web Content
CRODA JAPAN KK
Active
IV
16695
2003-06-30
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CRODA JAPAN KK
Inactive
IV
16694
2003-06-30
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CRODA EUROPE LTD
Active
IV
33665
2019-03-25
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CRODA INC
Active
IV
22402
2009-01-05
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CRODA JAPAN KK
Inactive
IV
22989
2009-07-22
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CRODA INC
Inactive
IV
17071
2003-12-02
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ARLACEL P135 (PEG 30 DIPOLYHYDROXYSTEARATE)

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CRODA INC
Inactive
IV
23074
2009-08-01
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CRODALAN AWS

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CRODA INC
Inactive
IV
24065
2010-08-15
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CRODESTA SL 40E (SUCROSE COCOATE)

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CRODA INC
Inactive
IV
22035
2008-09-01
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GLYCERYL DIOLEATE

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CRODA EUROPE LTD
Active
IV
28921
2014-12-15
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