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

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01 'd' TUBOCURARINE CHLORIDE (1)

02 17-ALPHA DIHYDROEQUILIN SODIUM SULPHATE (1)

03 2'-DEOXY-5-AZACYTIDINE (1)

04 2-PHENYL-1,3-PROPANEDIOL DICARBAMATE (1)

05 6-ALPHA-METHYLPREDNISOLONE SODIUM SUCCINATE (1)

06 6a-METHYLPREDNISOLONE (1)

07 ALLOPURINOL (1)

08 ALPRAZOLAM (1)

09 ALTRENOGEST (1)

10 ANDROSTADIENOLONE UNDECYLENATE (1)

11 ANDROSTERONE (1)

12 APOMORPHINE HYDROCHLORIDE (1)

13 ATC/2 OXALATE (1)

14 BEPRIDIL HYDROCHLORIDE (1)

15 BETAMETHASONE ACETATE (1)

16 BETAMETHASONE DIPRIONATE (1)

17 BETAMETHASONE MICRO (1)

18 BETAMETHASONE SODIUM PHOSPHATE IN THE OSS FACIL. ON KLOOSTERSTRAT 6 (1)

19 BETAMETHASONE VALERATE (1)

20 BOVINE INSULIN (1)

21 BOVINE INSULIN HIGHLY PURIFIED (2)

22 BOVINE INSULINE HIGHLY PURIFIED (1)

23 BUPRENORPHINE (1)

24 CHENODEOXYCHOLIC ACID (1)

25 CHENODEOXYCHOLIC ACID H.M. (1)

26 CLONAZEPAM (1)

27 CODEINE PHOSPHATE (1)

28 CORTICOSTERONE (1)

29 CORTICOTROPIN (1)

30 CORTISONE ACETATE MICRO (1)

31 DEHYDRO ISOANDROSTERONE (1)

32 DEHYDRO ISOANDROSTERONE ACETATE (1)

33 DEHYDRO ISOANDROSTERONE SODIUM SULPHATE (1)

34 DEHYDROISOANDROSTERONE SODIUM SULPHATE (1)

35 DESMOPRESSIN (1)

36 DEXAMETHASONE ACETATE MICRO AND NON MICRO (1)

37 DEXAMETHASONE MICRO AND NON-MICRO (1)

38 DEXAMETHASONE SODIUM PHOSPHATE (1)

39 EQUILIN SODIUM SULPHATE STABILIZED (1)

40 ESTRADIOL BENZOATE (1)

41 ESTRADIOL CYPIONATE (2)

42 ESTRADIOL GLUCOSIDE (1)

43 ESTRADIOL VALERATE MICRO (1)

44 ESTRIOL (1)

45 ESTRONE MICRONIZED (1)

46 FACILITIES AND OPERATING PROCEDURES AT DIOSYNTH FRANCE S.A. IN USINE SAINT-CHARLES ERAGNY-SUR-EPTE, FRANCE (1)

47 FENTANYL CITRATE (1)

48 FLUVOXAMINE MALEATE (1)

49 GLUCAGON (1)

50 GONADORELIN ACETATE (1)

51 HEPARIN CALCIUM (1)

52 HEPARIN SODIUM (3)

53 HEPARIN SODIUM (CRUDE) FROM BEEF LUNGS (1)

54 HEPARIN SODIUM USP (BEEF LUNG) (1)

55 HUMAN MENOPAUSAL GONADOTROPHIN NATURAL - OSS, THE NETHERLANDS (1)

56 HYALURONIDASE (1)

57 HYDROCORTISONE ACETATEMICRO (1)

58 HYDROCORTISONE HEMISUCCINATE MICRO (1)

59 HYDROCORTISONE MICRONIZED (1)

60 HYDROCORTISONE SODIUM PHOSPHATE (1)

61 HYDROCORTISONE SODIUM SUCCINATE (1)

62 HYDROMORPHONE HYDROCHLORIDE (1)

63 HYDROXYPROGESTERONE CAPROATE (2)

64 ISOLATION AND PURIFICATION OF HEPARIN SODIUM USP FROM BEEF LUNGS (1)

65 L-ALPHA-METHYLDOPATE HYDROCHLORIDE (1)

66 L-PROPLYL-L-LEUCYL-GLYCINAMIDE (MIF) (1)

67 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN OSS, HOLLAND. (1)

68 MEGESTROL ACETATE FROM GRANULATE (1)

69 MEGESTROL ACETATE MICRO (1)

70 METHANDRIOL (1)

71 METHANDRIOL DIPROPIONATE (1)

72 METHDILAZINE (1)

73 METHDILAZINE HYDROCHLORIDE (1)

74 METHYLPREDNISOLONE (1)

75 METHYLPREDNISOLONE ACETATE (1)

76 METHYLPREDNISOLONE HEMISUCCINATE (1)

77 METOCURINE IODIDE (1)

78 METOLAZONE (1)

79 MIANSERIN HYDROCHLORIDE (1)

80 MIDAZOLAM (1)

81 MIRTAZAPINE (1)

82 NALOXONE HYDROCHLORIDE (1)

83 NALTREXONE (1)

84 NOERTHINDRONE ACETATE MICRONIZED (1)

85 NOMEGESTROL ACETATE (1)

86 NORANDROSTENEDIONE --NANDROLONE (1)

87 NORETHYNODREL (1)

88 NORGESTOMET (1)

89 ORF 170 70 (1)

90 ORG 7417 (1)

91 ORG 9487 (1)

92 ORGANIZATION, FACILITIES AND MANUFACTURING FACILITIES (1)

93 ORGOTEIN (1)

94 OXYMORPHONE HYDROCHLORIDE (1)

95 OXYTOCIN ACETATE (1)

96 PANCURONIUM BROMIDE (2)

97 PORCINE INSULIN (HIGHLY PURIFIED) (1)

98 PRAZEPAM (1)

99 PREDNISOLONE ACETATE MICRO (1)

100 PREDNISOLONE MICRO (1)

101 PREDNISOLONE SODIUM PHOSPHATE (1)

102 PREDNISOLONE SUCCINATE (1)

103 PREDNISOLONE TEBUTATE (1)

104 PREDNISONE MICRO (1)

105 PREGNANT MARE SERUM GONADOTROPHIN (PMSG) FROM PREGNANT MARE PLASMA (1)

106 PREGNANT MARE SERUM GONADOTROPIN (PMSG)(CRUDE) (1)

107 PREGNANT MARE SERUM GONADOTROPIN CURDE (PMSG) (1)

108 PREGNENOLONE HEMISUCCINATE (1)

109 PROTEIN HYDROLYSATE (1)

110 SODIUM HEPARIN (1)

111 SPIRONOLACTONE MICRO (1)

112 STABILIZED ESTRONE SODIUM SULPHATE (1)

113 STANOLONE (1)

114 STERILE PROCESSING FACILITY IN JAPAN (1)

115 TESTOSTERONE (1)

116 TESTOSTERONE CYPIONATE (1)

117 TRENBOLONE ACETATE (1)

118 TRIAMCINOLONE ACETONIDE MICRO (1)

119 TRIAMCINOLONE DIACETATE (1)

120 TRIAMCINOLONE MICRO (1)

121 TRIAZOLAM (1)

122 UROFOLLITROPHIN (1)

123 VECURONIUM BROMIDE (1)

124 VECURONIUMBROMIDE SECOND SUBMISSION 12-17-81 (1)

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01 DIOSYNTH (1)

02 DIOSYNTH BV (118)

03 DIOSYNTH INC (9)

04 MERCK SHARP & DOHME B.V., A SUBSIDIARY OF MERCK & CO., INC (1)

05 MERCK SHARP AND DOHME BV (1)

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01 Italy (1)

02 Netherlands (1)

03 United Kingdom (128)

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01 Inactive (130)

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01 Blank (130)

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DIOSYNTH BV
Inactive
3799
N/A
1980-05-20
II
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DIOSYNTH BV
Inactive
7007
N/A
1987-06-08
II
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DIOSYNTH BV
Inactive
8508
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1990-04-05
II
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DIOSYNTH BV
Inactive
7267
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1987-12-29
II
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DIOSYNTH BV
Inactive
6560
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1986-08-29
II
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DIOSYNTH BV
Inactive
3636
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1979-11-02
II
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DIOSYNTH BV
Inactive
4950
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1983-02-15
II
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DIOSYNTH BV
Inactive
9128
N/A
1991-05-20
II
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DIOSYNTH BV
Inactive
16346
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2003-01-03
II
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DIOSYNTH BV
Inactive
3827
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1980-05-21
II
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