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Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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

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01 7-AMINO-DESACETOXY-CEPHALOSPORANIC ACID (1)

02 ALENDRONATE SODIUM TRIHYDRATE (1)

03 ALMOTRIPTAN MALATE (1)

04 AMLODIPINE BESYLATE (1)

05 ARGININE (STERILE BULK) (1)

06 ARIPIPRAZOLE (NON-STERILE BULK API) (1)

07 ARMODAFINIL (1)

08 AVIBACTAM SODIUM STERILE (1)

09 AZTREONAM (1)

10 CARVEDILOL (1)

11 CEFADROXIL (1)

12 CEFAZOLIN SODIUM, USP (STERILE BULK) (1)

13 CEFAZOLIN USP (1)

14 CEFDINIR FORM-B (1)

15 CEFDITOREN PIVOXIL (1)

16 CEFEPIME & ARGININE (STERILE BULK) (1)

17 CEFEPIME HCI USP (1)

18 CEFEPIME HYDROCHLORIDE (STERILE BULK) (1)

19 CEFIXIME (PROCESS 2) (1)

20 CEFIXIME, USP (1)

21 CEFOTAXIME SODIUM, USP (STERILE BULK) (1)

22 CEFOXITIN SODIUM USP (STERILE) (1)

23 CEFPODOXIME PROXETIL USP (NON-STERILE BULK) (1)

24 CEFPROZIL (1)

25 CEFPROZIL (PROCESS-2) (1)

26 CEFTAZIDIME (STERILE) (1)

27 CEFTAZIDIME + AVIBACTAM (STERILE) (1)

28 CEFTAZIDIME + SODIUM CARBONATE (STERILE BULK) (1)

29 CEFTRIAXONE SODIUM (2)

30 CEFUROXIME ACID (2)

31 CEFUROXIME AXETIL (CRYSTALLINE) (NON-STERILE BULK API) (1)

32 CEFUROXIME AXETIL, AMORPHOUS (1)

33 CEFUROXIME AXETIL, CRYSTALLINE (1)

34 CEFUROXIME SODIUM (STERILE) (1)

35 CEPHALEXIN USP (1)

36 CEPHALOSPORIN INTERMEDIATE (CAVA) (1)

37 CETIRIZINE DIHYDROCHLORIDE (1)

38 CLOPIDOGREL BISULFATE (1)

39 DESLORATADINE (1)

40 DEXLANSOPRAZOLE (1)

41 DIPYRIDAMOLE (1)

42 DIVALPROEX SODIUM (1)

43 DULOXETINE HYDROCHLORIDE (NON-STERILE BULK API) (1)

44 ESZOPICLONE (NON-STERILE BULK API) (1)

45 FELODIPINE (NON-STERILE BULK API) (1)

46 GEMIFLOXACIN MESYLATE (NON-STERILE BULK API) (1)

47 GRANISETRON HYDROCHLORIDE (1)

48 IBANDRONATE SODIUM (1)

49 ISA (INTERMEDIATE) (1)

50 LANSOPRAZOLE (NON-STERILE BULK API) (1)

51 LEVETIRACETAM (1)

52 LEVOFLOXACIN (NON-STRILE BULK API) (1)

53 LOSARTAN POTASSIUM (NON-STERILE BULK API) (1)

54 MEMANTINE HYDROCHLORIDE (1)

55 MODAFINIL (1)

56 NARATRIPTAN HYDROCHLORIDE (NON-STERILE BULK API) (1)

57 NISOLDIPINE (NON-STERILE BULK API) (1)

58 OLANZAPINE (1)

59 PALIPERIDONE (1)

60 PANTOPRAZOLE SODIUM (NON-STERILE BULK API) (1)

61 PAROXETINE HYDROCHLORIDE (1)

62 PHENYTOIN SODIUM (1)

63 PRAMIPEXOLE DIHYDROCHLORIDE (1)

64 QUETIAPINE FUMARATE (NON STERILE BULK API) (1)

65 RABEPRAZOLE SODIUM (1)

66 RASAGILINE MESYLATE (NON STERILE BULK API) (1)

67 RISEDRONATE SODIUM (1)

68 RIVASTIGMINE TARTRATE (1)

69 ROPINIROLE HYDROCHLORIDE (NON-STERILE BULK API) (1)

70 SODIUM CARBONATE (STERILE) (1)

71 SUMATRIPTAN SUCCINATE (1)

72 TADALAFIL (1)

73 TERBINAFINE HYDROCHLORIDE (NON-STERILE BULK) (1)

74 TOLTERODINE TARTRATE (NON-STERILE BULK API) (1)

75 TRANS RESVERATROL (1)

76 TRANS-RESVERATROL (SERIES A) (1)

77 VENLAFAXINE HYDROCHLORIDE (1)

78 ZALEPLON (1)

79 ZOLMITRIPTAN (1)

80 ZOLPIDEM TARTRATE (1)

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01 ORBION PHARMACEUTICALS PRIVATE LTD (30)

02 ORCHID CHEMICALS AND PHARMACEUTICALS LTD (7)

03 ORCHID PHARMA LTD (45)

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01 India (80)

02 Blank (2)

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01 Active (75)

02 Inactive (7)

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01 Complete (6)

02 Blank (76)

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ORCHID PHARMA LTD
Active
15228
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2001-01-04
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ORCHID PHARMA LTD
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20415
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2007-04-06
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ORCHID PHARMA LTD
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26177
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2012-07-13
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ORBION PHARMACEUTICAL...
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19582
N/A
2006-07-07
II
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ORCHID PHARMA LTD
Active
18843
N/A
2005-10-07
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ORBION PHARMACEUTICAL...
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21937
N/A
2008-09-20
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ORCHID PHARMA LTD
Active
25031
N/A
2011-06-23
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ORCHID PHARMA LTD
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39355
Complete
2024-03-06
2024-02-23
2024-01-23
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ORCHID CHEMICALS AND ...
Inactive
20014
N/A
2006-12-05
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ORCHID CHEMICALS AND ...
Inactive
19373
N/A
2006-04-18
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