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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hubei Gedian Humanwell Pharmaceutical

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01 16Alpha-Hydroxyprednisolone (1)

02 Abiraterone Acetate (1)

03 Abiraterone Decanoate (1)

04 Apalutamide (1)

05 Baloxavir Marboxil (1)

06 Budesonide (1)

07 Cariprazine Hydrochloride (1)

08 Clascoterone (1)

09 Cyproterone Acetate (2)

10 Desonide (1)

11 Dienogest (1)

12 Drospirenone (1)

13 Dutasteride (2)

14 Eplerenone (1)

15 Escitalopram Oxalate (1)

16 Eslicarbazepine Acetate (1)

17 Estradiol (1)

18 Estradiol Valerate (1)

19 Estriol (1)

20 Estrone (1)

21 Ethinyl Estradiol (1)

22 Exemestane (1)

23 Finasteride (2)

24 Fluticasone Furoate (1)

25 Fluticasone Propionate (1)

26 Fulvestrant (1)

27 Ganciclovir (1)

28 Ganciclovir Sodium (1)

29 Gestodene (1)

30 Lasmiditan (1)

31 Levonorgestrel (1)

32 Luliconazole (1)

33 Medroxyprogesterone Acetate (1)

34 Megestrol Acetate (1)

35 Methylprednisolone (1)

36 Methylprednisolone Hemisuccinate (1)

37 Mifepristone (1)

38 Mirabegron (1)

39 Nintedanib Esylate (1)

40 Oseltamivir Phosphate (1)

41 Oxcarbazepine (2)

42 Phloroglucinol (1)

43 Prasterone Acetate (1)

44 Prednisolone (1)

45 Pregnenolone (1)

46 Progesterone (2)

47 Relugolix (1)

48 Revefenacin (1)

49 Tadalafil (1)

50 Testosterone (1)

51 Testosterone Acetate (1)

52 Testosterone Cypionate (1)

53 Testosterone Decanoate (1)

54 Testosterone Dodecanoate (1)

55 Testosterone Enanthate (1)

56 Testosterone Isocaproate (1)

57 Testosterone Propionate (1)

58 Testosterone Undecanoate (1)

59 Tibolone (1)

60 Ursodeoxycholic Acid (1)

61 Valganciclovir Hydrochloride (1)

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01 Active (17)

02 Blank (49)

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01 Valid (11)

02 Withdrawn by Holder (1)

03 Blank (54)

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01 230MF10079 (1)

02 Blank (65)

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01 HB230032 (4)

02 Blank (62)

See all info for this product

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USDMF

Found USDMF

25056
Active
FINASTERIDE
2011-06-17
CEP/COS

Found CEP/COS

R1-CEP 2013-238 - Rev 00
Valid
Finasteride
2020-05-28
Japanese DMF

Found JDMF

230MF10079
Finasteride at GEDIAN ECONOMIC DEVE...
2018-07-05
Written Confirmation

Found WC

HB230032
Valid
Finasteride
2023-11-13
Application Number
25056
230MF10079
HB230032
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2026-11-12
Filing Details
FINASTERIDE
Finasteride
Finasteride at GEDIAN ECONOMIC DEVE...
Finasteride
Issue/Submission Date
2011-06-17
2020-05-28
2018-07-05
2023-11-13
See all info for this product

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USDMF

Found USDMF

34268
Active
BUDESONIDE
2019-10-29
CEP/COS

Found CEP/COS

R0-CEP 2019-295 - Rev 00
Valid
Budesonide, Micronised
2020-07-17
Japanese DMF

Close JDMF

Written Confirmation

Found WC

HB230032
Valid
Budesonide
2023-11-13
Application Number
34268
HB230032
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2026-11-12
Filing Details
BUDESONIDE
Budesonide, Micronised
Budesonide
Issue/Submission Date
2019-10-29
2020-07-17
2023-11-13
See all info for this product

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USDMF

Found USDMF

33000
Active
LEVONORGESTREL
2022-06-24
CEP/COS

Found CEP/COS

R0-CEP 2022-199 - Rev 00
Valid
Levonorgestrel, Non-micronised and ...
2023-05-19
Japanese DMF

Close JDMF

Written Confirmation

Found WC

HB230032
Valid
Levonorgestrel
2023-11-13
Application Number
33000
HB230032
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2026-11-12
Filing Details
LEVONORGESTREL
Levonorgestrel, Non-micronised and ...
Levonorgestrel
Issue/Submission Date
2022-06-24
2023-05-19
2023-11-13
See all info for this product

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USDMF

Found USDMF

27668
Active
PROGESTERONE
2013-11-01
CEP/COS

Found CEP/COS

R1-CEP 2013-328 - Rev 00
Valid
Progesterone
2020-05-26
Japanese DMF

Close JDMF

Written Confirmation

Found WC

HB230032
Valid
Progesterone
2023-11-13
Application Number
27668
HB230032
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2026-11-12
Filing Details
PROGESTERONE
Progesterone
Progesterone
Issue/Submission Date
2013-11-01
2020-05-26
2023-11-13
See all info for this product

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USDMF

Found USDMF

37957
Active
DIENOGEST
2023-01-18
CEP/COS

Found CEP/COS

CEP 2023-045 - Rev 00
Valid
Dienogest, Micronised
2024-02-15
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
37957
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
DIENOGEST
Dienogest, Micronised
Issue/Submission Date
2023-01-18
2024-02-15
See all info for this product

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USDMF

Found USDMF

26803
Active
DUTASTERIDE
2013-01-09
CEP/COS

Found CEP/COS

R0-CEP 2020-298 - Rev 01
Valid
Dutasteride, Non-micronised and mic...
2021-07-05
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
26803
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DUTASTERIDE
Dutasteride, Non-micronised and mic...
Issue/Submission Date
2013-01-09
2021-07-05
See all info for this product

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USDMF

Found USDMF

32999
Active
OXCARBAZEPINE
2018-07-22
CEP/COS

Found CEP/COS

R0-CEP 2018-165 - Rev 01
Valid
Oxcarbazepine, Micronised and non-m...
2023-07-07
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32999
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
OXCARBAZEPINE
Oxcarbazepine, Micronised and non-m...
Issue/Submission Date
2018-07-22
2023-07-07
See all info for this product

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USDMF

Found USDMF

33003
Active
PROGESTERONE (PROCESS II)
2018-07-25
CEP/COS

Found CEP/COS

CEP 2018-166 - Rev 01
Valid
Progesterone, Process B
2024-01-19
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33003
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
PROGESTERONE (PROCESS II)
Progesterone, Process B
Issue/Submission Date
2018-07-25
2024-01-19
See all info for this product

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USDMF

Found USDMF

37074
Active
TESTOSTERONE
2022-09-07
CEP/COS

Found CEP/COS

R0-CEP 2022-181 - Rev 00
Valid
Testosterone, Micronised, non-micro...
2023-08-22
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
37074
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
TESTOSTERONE
Testosterone, Micronised, non-micro...
Issue/Submission Date
2022-09-07
2023-08-22
URL Supplier Web Content
See all info for this product

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USDMF

Found USDMF

33602
Active
16A-HYDROXYPREDNISOLONE (INTERMEDIA...
2019-03-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33602
Status
Active
Fees Paid
N/A
 
Filing Details
16A-HYDROXYPREDNISOLONE (INTERMEDIA...
Issue/Submission Date
2019-03-27
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