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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Medichem S.a

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01 Adapalene (1)

02 Alendronate Sodium (1)

03 Ambrisentan (1)

04 Amikacin (1)

05 Amoxapine (1)

06 Apixaban (1)

07 Asenapine Maleate (1)

08 Brimonidine Tartrate (1)

09 Buprenorphine (1)

10 Captopril (1)

11 Cenobamate (1)

12 Chlorhexidine (1)

13 Chlorhexidine Acetate (1)

14 Chlorhexidine Gluconate (2)

15 Chlorhexidine Hydrochloride (1)

16 Cinacalcet Hydrochloride (1)

17 Clozapine (1)

18 Cyclobenzaprine (1)

19 Desvenlafaxine Succinate (1)

20 Disodium Hydrogen Phosphate (1)

21 Edaravone (1)

22 Elexacaftor (1)

23 Enalapril Maleate (1)

24 Encorafenib (1)

25 Felodipine (1)

26 Fluvoxamine (1)

27 Gabapentin (1)

28 Guanfacine (1)

29 Ivacaftor (1)

30 Lamotrigine (1)

31 Levoketoconazole (1)

32 Lofexidine (1)

33 Lorlatinib (1)

34 Loxapine (1)

35 Loxapine Succinate (1)

36 Lumacaftor (1)

37 Lumateperone Tosylate (1)

38 Mexiletine (1)

39 Micafungin (1)

40 Mirtazapine (1)

41 Naloxone Hydrochloride (1)

42 Naltrexone (1)

43 Nepafenac (1)

44 Octenidine Hydrochloride (1)

45 Olopatadine Hydrochloride (1)

46 Opicapone (1)

47 Pantoprazole Sodium (1)

48 Paroxetine Hydrochloride (1)

49 Pazopanib Hydrochloride (1)

50 Pimecrolimus (1)

51 Potassium Phosphate (1)

52 Prucalopride Succinate (1)

53 Quetiapine Hemifumarate (1)

54 Rasagiline Tartrate (1)

55 Relugolix (1)

56 Revefenacin (1)

57 Rimegepant Sulfate (1)

58 Risperidone (1)

59 Rivaroxaban (1)

60 Ruxolitinib Phosphate (1)

61 Solifenacin Succinate (1)

62 Sugammadex Sodium (1)

63 Sunitinib (1)

64 Tamsulosin (1)

65 Tezacaftor (1)

66 Varenicline Tartrate (1)

67 Venlafaxine Hydrochloride (1)

68 Vibegron (1)

69 Voclosporin (1)

70 Voriconazole (1)

71 Zanubrutinib (1)

72 Blank (2)

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01 Active (43)

02 Blank (31)

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01 Valid (18)

02 Blank (56)

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01 301MF10021 (1)

02 305MF10019 (1)

03 Blank (72)

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01 Blank (74)

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USDMF

Found USDMF

10534
Active
CLOZAPINE
1993-10-21
CEP/COS

Found CEP/COS

R1-CEP 2008-151 - Rev 00
Valid
Clozapine
2015-07-13
Japanese DMF

Found JDMF

301MF10021
Clozapine at 6-8, Fructo(´)s Gelab...
2019-06-25
Written Confirmation

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Application Number
10534
301MF10021
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CLOZAPINE
Clozapine
Clozapine at 6-8, Fructo(´)s Gelab...
Issue/Submission Date
1993-10-21
2015-07-13
2019-06-25
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USDMF

Found USDMF

15601
Active
BRIMONIDINE TARTRATE
2001-08-27
CEP/COS

Found CEP/COS

R1-CEP 2013-353 - Rev 00
Valid
Brimonidine tartrate
2019-04-24
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
15601
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
BRIMONIDINE TARTRATE
Brimonidine tartrate
Issue/Submission Date
2001-08-27
2019-04-24
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USDMF

Found USDMF

9573
Active
CHLORHEXIDINE ACETATE
1992-03-10
CEP/COS

Found CEP/COS

CEP 2018-123 - Rev 02
Valid
Chlorhexidine diacetate
2024-02-19
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
9573
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CHLORHEXIDINE ACETATE
Chlorhexidine diacetate
Issue/Submission Date
1992-03-10
2024-02-19
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USDMF

Found USDMF

9701
Active
CHLORHEXIDINE GLUCONATE
1992-05-27
CEP/COS

Found CEP/COS

R1-CEP 1993-009 - Rev 04
Valid
Chlorhexidine digluconate solution
2009-02-16
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
9701
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CHLORHEXIDINE GLUCONATE
Chlorhexidine digluconate solution
Issue/Submission Date
1992-05-27
2009-02-16
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USDMF

Found USDMF

25149
Active
CHLORHEXIDINE GLUCONATE SOLUTION (D...
2011-07-25
CEP/COS

Found CEP/COS

R1-CEP 2017-128 - Rev 00
Valid
Chlorhexidine digluconate solution,...
2022-07-18
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
25149
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CHLORHEXIDINE GLUCONATE SOLUTION (D...
Chlorhexidine digluconate solution,...
Issue/Submission Date
2011-07-25
2022-07-18
See all info for this product

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USDMF

Found USDMF

17143
Active
CHLORHEXIDINE DIHYDROCHLORIDE
2004-02-04
CEP/COS

Found CEP/COS

CEP 2018-081 - Rev 02
Valid
Chlorhexidine dihydrochloride
2024-02-19
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
17143
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CHLORHEXIDINE DIHYDROCHLORIDE
Chlorhexidine dihydrochloride
Issue/Submission Date
2004-02-04
2024-02-19
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USDMF

Found USDMF

14099
Active
FELODIPINE
1999-05-03
CEP/COS

Found CEP/COS

R1-CEP 2004-213 - Rev 01
Valid
Felodipine
2012-05-18
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
14099
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FELODIPINE
Felodipine
Issue/Submission Date
1999-05-03
2012-05-18
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USDMF

Found USDMF

15749
Active
MIRTAZAPINE
2001-12-05
CEP/COS

Found CEP/COS

R1-CEP 2007-178 - Rev 00
Valid
Mirtazapine
2013-09-05
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
15749
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
MIRTAZAPINE
Mirtazapine
Issue/Submission Date
2001-12-05
2013-09-05
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USDMF

Found USDMF

18052
Active
PAROXETINE HYDROCHLORIDE HEMIHYDRAT...
2005-02-01
CEP/COS

Found CEP/COS

R1-CEP 2011-200 - Rev 00
Valid
Paroxetine hydrochloride hemihydrat...
2018-03-05
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
18052
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
PAROXETINE HYDROCHLORIDE HEMIHYDRAT...
Paroxetine hydrochloride hemihydrat...
Issue/Submission Date
2005-02-01
2018-03-05
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USDMF

Found USDMF

28833
Active
QUETIAPINE FUMARATE
2014-12-05
CEP/COS

Found CEP/COS

CEP 2014-081 - Rev 01
Valid
Quetiapine Fumarate
2023-12-12
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
28833
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
QUETIAPINE FUMARATE
Quetiapine Fumarate
Issue/Submission Date
2014-12-05
2023-12-12
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