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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Fresenius Se & Co. Kgaa to the U.S. FDA. Original Data : FDA Website

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01 AFATINIB DIMALEATE (1)

02 ALECTINIB HYDROCHLORIDE (1)

03 AMOXICILLIN SODIUM STERILE (1)

04 AMPICILLIN SODIUM STERILE (1)

05 AMPICILLIN SODIUM/SULBACTAM SODIUM (1)

06 AMPICILLIN TRIHYDRATE STERILE (1)

07 ANASTROZOLE (1)

08 BELINOSTAT (1)

09 BENDAMUSTINE HYDROCHLORIDE (1)

10 BICALUTAMIDE (1)

11 BUFFERED CEFTAZIDIME PENTAHYDRATE, STERILE (1)

12 BUFFERED NAFCILLIN SODIUM STERILE (1)

13 BUFFERED OXACILLIN SODIUM STERILE (1)

14 BUFFERED PENICILLIN G POTASSIUM STERILE (1)

15 BUFFERED PENICILLIN G SODIUM STERILE (1)

16 BUPIVACAINE HYDROCHLORIDE (1)

17 BUSULFAN (1)

18 CALCITONIN SALMON (1)

19 CARBOPLATIN (1)

20 CARFILZOMIB (1)

21 CEFEPIME ARGININE STERILE (1)

22 CEFEPIME HYDROCHLORIDE STERILE (1)

23 CEFOXITIN SODIUM (STERILE) DRUG SUBSTANCE (1)

24 CEFTAZIDIME PENTAHYDRATE STERILE BUFFERED / AVIBACTAM SODIUM STERILE (4:1) (1)

25 CEFTRIAXONE SODIUM STERILE (1)

26 CEFUROXIME SODIUM STERILE (1)

27 CEPHAPIRIN BENZATHINE STERILE (1)

28 CEPHAPIRIN SODIUM STERILE (1)

29 CLOXACILLIN BENZATHINE STERILE (1)

30 CLOXACILLIN SODIUM (1)

31 DECITABINE (1)

32 DEGARELIX ACETATE (1)

33 DISODIUM PAMIDRONATE (1)

34 DOCETAXEL (1)

35 FACILITIES AND CONTROLS FOR DELKA, S.A. (SAN SALVADOR, EL SALVADOR CA) (1)

36 GEMCITABINE HYDROCHLORIDE (1)

37 GLUCAGON (1)

38 HETACILLIN POTASSIUM STERILE (1)

39 IBRUTINIB (1)

40 IRINOTECAN HYDROCHLORIDE TRIHYDRATE (1)

41 LACTULOSE CONCENTRATE USP (1)

42 LACTULOSE CRYSTALS (1)

43 LACTULOSE SOLUTION USP (2)

44 LETROZOLE (1)

45 LIRAGLUTIDE (1)

46 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CANTON, MASSACHUSETTS. (1)

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

48 MCT LIPID EMULSION (1)

49 METAXALONE (1)

50 OCTREOTIDE ACETATE (1)

51 OXALIPLATIN (1)

52 PACLITAXEL SEMISYNTHETIC (1)

53 PENICILLIN G SODIUM STERILE (1)

54 PIPERACILLIN SODIUM/ TAZOBACTAM SODIUM (8:1) STERILE LYOPHILIZED (1)

55 PIVMECILLINAM HYDROCHLORIDE (1)

56 PLERIXAFOR (1)

57 RIBOCICLIB SUCCINATE (1)

58 ROPIVACAINE HYDROCHLORIDE (1)

59 ROPIVACAINE HYDROCHLORIDE ANHYDROUS (1)

60 SUGAMMADEX SODIUM (1)

61 TEMSIROLIMUS (1)

62 TOPOTECAN HYDROCHLORIDE (1)

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01 FRESENIUS KABI ANTI INFECTIVES SRL (4)

02 FRESENIUS KABI AUSTRIA GMBH (4)

03 FRESENIUS KABI CLAYTON L P (1)

04 FRESENIUS KABI IPSUM SRL (24)

05 FRESENIUS KABI ONCOLOGY LTD (27)

06 FRESENIUS USA INC (3)

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01 Austria (4)

02 Germany (5)

03 India (10)

04 Italy (3)

05 Sweden (37)

06 U.S.A (4)

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01 Active (44)

02 Inactive (19)

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01 Complete (19)

02 Blank (44)

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FRESENIUS KABI ONCOLO...
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2016-12-31
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FRESENIUS KABI ONCOLO...
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2019-06-12
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FRESENIUS KABI IPSUM ...
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38349
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2023-05-17
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FRESENIUS KABI IPSUM ...
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2009-11-20
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FRESENIUS KABI IPSUM ...
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25477
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2011-11-03
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FRESENIUS KABI IPSUM ...
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23699
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2010-04-07
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FRESENIUS KABI ONCOLO...
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20660
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2007-07-06
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FRESENIUS KABI ONCOLO...
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32260
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2018-01-05
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FRESENIUS KABI ONCOLO...
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26656
N/A
2012-12-21
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FRESENIUS KABI ONCOLO...
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20099
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2006-12-28
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