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

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01 16-ALPHA-HYDROXYPREDNISOLONE (1)

02 ASENAPINE MALEATE (1)

03 AZATHIOPRINE (1)

04 AZATHIOPRINE (PROCESS 3) (1)

05 BACLOFEN (1)

06 BACLOFEN (PROCESS 2) (1)

07 BENZTROPINE MESYLATE (1)

08 BUDESONIDE (1)

09 BUPRENORPHINE HYDROCHLORIDE (1)

10 CONJUGATED ESTROGENS TYPE CN (1)

11 DANAPAROID SODIUM (1)

12 DESMOPRESSIN (1)

13 DESOGESTREL (1)

14 EPTIFIBATIDE (1)

15 ESTRADIOL (1)

16 ESTRADIOL 3-ACETATE (1)

17 ESTRADIOL VALERATE (1)

18 ESTRIOL (1)

19 ETHINYL ESTRADIOL (1)

20 ETHYNODIOL DIACETATE (1)

21 ETONOGESTREL (1)

22 FLUPHENAZINE DECANOATE (1)

23 FLUPHENAZINE HYDROCHLORIDE (1)

24 FONDAPARINUX SODIUM USP (1)

25 GANIRELIX (1)

26 GONADERELIN DIACETATE TETRAHYDRATE (1)

27 GONADORELIN ACETATE (1)

28 HEPARIN SODIUM (1)

29 HEPARIN SODIUM CRUDE (PORCINE) (1)

30 HEPARIN SODIUM PORCINE (1)

31 HEPARIN SODIUM USP (1)

32 HUMAN CHORIONIC GONADOTROPHIN (HCG) (1)

33 HYDROXYPROGESTERONE CAPROATE (1)

34 LEUPRORELIN HIGHLY PURIFIED (1)

35 LEVALBUTEROL HYDROCHLORIDE (1)

36 METHAZOLAMIDE (1)

37 METHYLTESTOSTERONE (1)

38 MIRTAZAPINE (1)

39 NALOXONE HYDROCHLORIDE (1)

40 NALTREXONE HYDROCHLORIDE (1)

41 NANDROLONE DECANOATE (1)

42 NORETHINDRONE (1)

43 NORETHINDRONE ACETATE (1)

44 OXYTOCIN (1)

45 PENBUTOLOL SULFATE (1)

46 PROGESTERONE (1)

47 REMIFENTANIL HYDROCHLORIDE (1)

48 RIMEXOLONE (1)

49 ROCURONIUM BROMIDE (1)

50 ROPIVACAINE (1)

51 ROPIVACAINE HYDROCHLORIDE (1)

52 SCOPOLAMINE (HYOSCINE) (1)

53 TESTOSTERONE (1)

54 TESTOSTERONE CYPIONATE (1)

55 TESTOSTERONE ENANTHATE (1)

56 TESTOSTERONE UNDECANOATE (1)

57 TETRACOSACTIDE (1)

58 THIOTHIXENE (1)

59 VECURONIUM BROMIDE (1)

60 VINCRISTINE SULPHATE/VINBLASTINE SULPHATE (1)

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01 ASPEN API INC (1)

02 ASPEN OSS BV (42)

03 BIOICHEM OSS B V (1)

04 FINE CHEMICALS CORP PTY LTD (16)

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01 Netherlands (44)

02 South Africa (16)

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01 Active (59)

02 Inactive (1)

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01 Complete (28)

02 Blank (32)

ASPEN OSS BV
Active
34868
N/A
2020-06-10
II
FINE CHEMICALS CORP P...
Active
10119
N/A
1993-02-19
II
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Not Confirmed

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FINE CHEMICALS CORP P...
Active
34647
N/A
2020-09-18
II
FINE CHEMICALS CORP P...
Active
6421
N/A
1986-06-18
II
FINE CHEMICALS CORP P...
Active
35224
N/A
2020-10-16
II
FINE CHEMICALS CORP P...
Active
6914
Complete
2012-10-25
2012-12-19
1987-04-09
II
NA Not Available For Sales
ASPEN OSS BV
Active
10493
N/A
1993-09-23
II
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