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

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01 1, 2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHLINE (DOPC) (1)

02 ALC-0159 (1)

03 ALC-0315 (1)

04 ALPHA-AMYLASE TYPE III-A (1)

05 DIHYDROXYACETONE (1)

06 DOTAP CHLORIDE (1)

07 GUM, LOCUST BEAN (1)

08 ISOMERIC MIX 1,2/1,3-GDO (1)

09 L-ALPHA-PHOSPHATIDYLCHOLINE, TYPE III-E (HEXANE SOLUTION) (1)

10 L-ALPHA-PHOSPHATIDYLCHOLINE, TYPE IV-S (SIGMA CHEMICAL COMPANY) (1)

11 N,N-DIMETHYLACETAMIDE (99.9%, PH EUR) (1)

12 N-DODECYL B-D-MALTOSIDE (PRODUCT NO.D5795/STOCK NO. W 5309-4) (1)

13 N-DODECYL BETA-D-MALTOSIDE (1)

14 OLEYLAMINE, PURIFIED (AN EXCIPIENT) (1)

15 PATENT BLUE VIOLET (1)

16 POLYVINYL ALCOHOL 3-82 (1)

17 ROSE BENGAL (1)

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01 ALDRICH CHEMICAL CO INC (1)

02 MERCK AND CIE KMG (4)

03 MERCK KGAA (2)

04 SAFC PHARMA (1)

05 SIGMA ALDRICH IRELAND LTD (1)

06 SIGMA ALDRICH MANUFACTURING LLC (1)

07 SIGMA CHEMICAL CO (1)

08 SIGMA F AND D DIV LTD (5)

09 SIGMA-ALDRICH MANUFACTURING LLC (1)

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01 Germany (2)

02 Switzerland (4)

03 U.S.A (11)

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01 Active (7)

02 Inactive (10)

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MERCK AND CIE KMG
Active
IV
24819
2011-04-04
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MERCK AND CIE KMG
Active
IV
24579
2011-01-24
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SIGMA ALDRICH IRELAND L...
Inactive
IV
29898
2015-10-06
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SIGMA-ALDRICH MANUFACTU...
Active
IV
35918
2021-05-25
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ALDRICH CHEMICAL CO INC
Inactive
IV
7149
1987-09-14
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ALC-0159

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MERCK AND CIE KMG
Active
IV
38423
2023-07-07
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ALC-0315

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MERCK KGAA
Active
IV
38171
2023-08-07
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ALPHA-AMYLASE TYPE III-A

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SIGMA F AND D DIV LTD
Inactive
IV
2886
1977-03-25
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DIHYDROXYACETONE

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SIGMA F AND D DIV LTD
Inactive
IV
2779
1976-11-02
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GUM, LOCUST BEAN

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SIGMA F AND D DIV LTD
Inactive
IV
3822
1980-06-11
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