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01 117-Iodoandrosta-5,16-Dien-3Beta-Ol
02 1Abiraterone Acetate
03 1Apalutamide
04 1Benzalkonium
05 2Budesonide
06 3Cyproterone Acetate
07 1Desonide
08 1Dienogest
09 2Drospirenone
10 2Dutasteride
11 1Eplerenone
12 2Eslicarbazepine Acetate
13 2Estradiol
14 1Estradiol Valerate
15 3Finasteride
16 1Lasmiditan
17 2Levonorgestrel
18 2Medroxyprogesterone Acetate
19 1Methylprednisolone Hemisuccinate
20 1Mifepristone
21 1Mirabegron
22 1Nintedanib Esylate
23 2Oxcarbazepine
24 1Peramivir
25 1Prasterone
26 1Prednisolone
27 2Pregnenolone
28 5Progesterone
29 2Testosterone
30 1Testosterone Cypionate
31 1Testosterone Undecanoate
32 1Tibolone
33 1Valganciclovir Hydrochloride
34 1Blank
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01 23Active
02 29Blank
01 12Valid
02 1Withdrawn by Holder
03 39Blank
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01 1230MF10079
02 51Blank
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01 4HB230032
02 48Blank
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01 120140725-94-E-119-10
02 120210329-209-J-903
03 120231106-209-J-1317
04 120250805-209-J-1982
05 120251010-94-E-193-18
06 120260219-94-E-195-19
07 1Su289-17-ND
08 1Su289-17-ND(A)
09 1Su469-9-ND
10 1Su6206-2-ND
11 42Blank
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01 151508-001
02 251508-002
03 151508-003
04 151508-004
05 151508-006
06 151508-007
07 151508-008
08 151508-009
09 151508-010
10 151508-011
11 151508-012
12 151508-013
13 151508-014
14 151508-015
15 151508-016
16 151508-017
17 151508-019
18 151508-201
19 151508-202
20 151508-203
21 151508-204
22 151508-205
23 151508-206
24 151508-207
25 151508-208
26 151508-210
27 151508-211
28 151508-212
29 151508-213
30 170492-002
31 170492-003
32 170492-004
33 170492-005
34 170492-006
35 17Blank
01 52Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-27
Pay. Date : 2022-08-04
DMF Number : 25056
Submission : 2011-06-17
Status : Active
Type : II
Certificate Number : CEP 2013-238 - Rev 01
Issue Date : 2025-06-10
Type : Chemical
Substance Number : 1615
Status : Valid
Registration Number : 230MF10079
Registrant's Address : GEDIAN ECONOMIC DEVELOPMENT DISTRICT 436070, E-zhou, Hubei, China
Initial Date of Registration : 2018-07-05
Latest Date of Registration :
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-206
Start Marketing Date : 2024-11-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Eltech Pharmachem Co., Ltd.
Registration Date : 2026-02-19
Registration Number : 20260219-94-E-195-19
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No.1 Zhiqing Road, Railway Station Economic Development Zone, Huangzhou District, Huanggang City, Hubei Province, PR China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-03
Pay. Date : 2022-04-21
DMF Number : 34268
Submission : 2019-10-29
Status : Active
Type : II
Certificate Number : CEP 2019-295 - Rev 02
Issue Date : 2024-12-17
Type : Chemical
Substance Number : 1075
Status : Valid
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-208
Start Marketing Date : 2024-11-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2025-08-05
Registration Number : 20250805-209-J-1982
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No.1 Zhiqing Road, Railway Station Economic Development Zone, Huangzhou District, postal code: 438011, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-12-02
Pay. Date : 2022-08-15
DMF Number : 33000
Submission : 2022-06-24
Status : Active
Type : II
Certificate Number : CEP 2022-199 - Rev 01
Issue Date : 2025-11-13
Type : Chemical
Substance Number : 926
Status : Valid
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-203
Start Marketing Date : 2024-11-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-25
Pay. Date : 2018-07-27
DMF Number : 27668
Submission : 2013-11-01
Status : Active
Type : II
Certificate Number : CEP 2018-166 - Rev 04
Issue Date : 2025-02-04
Type : Chemical
Substance Number : 429
Status : Valid
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-201
Start Marketing Date : 2024-11-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-07-24
Pay. Date : 2025-07-10
DMF Number : 37957
Submission : 2023-01-18
Status : Active
Type : II
Certificate Number : CEP 2023-045 - Rev 01
Issue Date : 2025-03-04
Type : Chemical
Substance Number : 2732
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-24
Pay. Date : 2021-04-02
DMF Number : 26803
Submission : 2013-01-09
Status : Active
Type : II
Certificate Number : CEP 2020-298 - Rev 02
Issue Date : 2024-12-13
Type : Chemical
Substance Number : 2641
Status : Valid
NDC Package Code : 51508-207
Start Marketing Date : 2024-11-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Innovent
Registration Date : 2025-03-11
Registration Number : Su289-17-ND(A)
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No. 25, Juxian Road, Gedian Economic Development District, E-Zhou City, Hubei Province, PR China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-12
Pay. Date : 2019-02-12
DMF Number : 32999
Submission : 2018-07-22
Status : Active
Type : II
Certificate Number : CEP 2023-266 - Rev 02
Issue Date : 2024-11-21
Type : Chemical
Substance Number : 2577
Status : Valid
NDC Package Code : 51508-205
Start Marketing Date : 2024-11-18
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2023-11-06
Registration Number : 20231106-209-J-1317
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No. 199, Jianshe Avenue, Gedian Economic Development District, E-zhou City, Hubei Province

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-11
Pay. Date : 2021-01-12
DMF Number : 33003
Submission : 2018-07-25
Status : Active
Type : II
Certificate Number : CEP 2013-328 - Rev 01
Issue Date : 2025-04-15
Type : Chemical
Substance Number : 429
Status : Valid
NDC Package Code : 51508-202
Start Marketing Date : 2024-11-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-07-05
Pay. Date : 2023-05-26
DMF Number : 37074
Submission : 2022-09-07
Status : Active
Type : II
Certificate Number : CEP 2022-181 - Rev 01
Issue Date : 2024-07-23
Type : Chemical
Substance Number : 1373
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43155
Submission : 2025-11-25
Status : Active
Type : II

Hubei Gedian Humanwell Pharmaceutical is a supplier offers 41 products (APIs, Excipients or Intermediates).
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