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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Roche Diagnostics Gmbh to the U.S. FDA. Original Data : FDA Website

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01 4-EPITETRACYCLINE HYDROCHLORIDE (1)

02 5'-IODO-2'-DEOXYURIDINE (IDOXURIDINE, IDU) (1)

03 5-BROMO-2'-DEOXYURIDINE (1)

04 ADENOSINE DEAMINASE THERAPEUTIC GRADE (1)

05 ALPHA-METHYLDOPA, BULK FORM USP XIX (1)

06 AMINOPHYLLINE, HYDROUS (THEOPHYLLINE ETHYLENEDIAMINE, HYDROUS) (1)

07 AMINOPHYLLINE,ANHYDROUS(THEOPHYLLINE ETHYLENEDIAMINE,ANHYDROUS) (1)

08 BM 17.0744 NA (K-111) (1)

09 CARVEDILOL (1)

10 CATALASE THERAPEUTIC GRADE (1)

11 CHEMICAL PLANT HC-B 21 LOCATED IN MANNHEIM, GERMANY (1)

12 CYTOSINE - ARABINOFURANOSIDE (1)

13 D,L-METIPRANOLOL (1)

14 D-PHENYLALANINE (1)

15 DIGOXIN PRODUCTS (1)

16 DIHYDROXYPROPYLTHEOPHYLLINE (DYPHYLLINE) (1)

17 DOXEPIN (1)

18 FACILITIES AND OPERATING PROCEDURES IN MANNHEIM, GERMANY (1)

19 FRUCTOSE-1.6-BISPHOSPHATE (1)

20 GALACTOSE, THERAPEUTIC GRADE (1)

21 GUAIACOL-O-ETHYLBENZYLAMINE HCL (1)

22 GUAIACOL-O-ETHYLTOSYLATE (1)

23 IBANDRONATE, EDITION I (1)

24 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BARCELONA, SPAIN. (1)

25 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. (1)

26 METAXALONE (1)

27 METHYLDOPATE HYDROCHLORIDE (1)

28 N-DECYLMETHYLSULFOXIDE (1)

29 NITROFURANTOIN MACROCRYSTALLINE (1)

30 OXTRIPHYLLINE (CHOLINE THEOPHYLLINATE) (1)

31 PRODUCTION PLANT HC-B 4 AND EXTRACTION PLANT HC-B 10 IN MANNHEIM, GERMANY (1)

32 PROPRANOLOL HYDROCHLORIDE (1)

33 PROPYLTHIOURACIL (1)

34 QUINIDINE GLUCONATE & SULFATE USP XIX (BULK) & BP 1973 (1)

35 QUININE SULFATE (1)

36 SPIRONOLACTONE (BULK FORM) USP XIX, BP 1973 (1)

37 SULFADOXINE (1)

38 TABLETTING AND ENCAPSULATING FACILITIES (1)

39 TOPICYCLINE (1)

40 TORASEMIDE (1)

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01 BOEHRINGER KNOLL LTD (1)

02 BOEHRINGER MANNHEIM GMBH (16)

03 BOEHRINGER MANNHEIM SA (4)

04 ROCHE DIAGNOSTICS GMBH (19)

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01 Germany (40)

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01 Inactive (40)

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01 Blank (40)

URL Supplier Web Content
BOEHRINGER MANNHEIM S...
Inactive
11917
N/A
1996-04-09
II
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ROCHE DIAGNOSTICS GMB...
Inactive
3699
N/A
1980-01-18
II
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ROCHE DIAGNOSTICS GMB...
Inactive
12277
N/A
1996-12-16
II
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ROCHE DIAGNOSTICS GMB...
Inactive
8225
N/A
1989-09-21
II
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BOEHRINGER MANNHEIM G...
Inactive
3345
N/A
1978-10-11
II
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BOEHRINGER MANNHEIM G...
Inactive
3966
N/A
1980-09-26
II
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BOEHRINGER MANNHEIM G...
Inactive
3962
N/A
1980-09-25
II
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ROCHE DIAGNOSTICS GMB...
Inactive
20587
N/A
2007-06-05
II
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BOEHRINGER MANNHEIM G...
Inactive
8106
N/A
1989-06-12
II
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ROCHE DIAGNOSTICS GMB...
Inactive
9468
N/A
1991-12-18
II
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