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Events
Webinars & Exhibitions
PEGS Boston SummitPEGS Boston Summit
Industry Trade Show
Not Confirmed
11 May-15 November, 2026
DIA Global Annual Meet...DIA Global Annual Meeting
Industry Trade Show
Not Confirmed
14-18 June, 2026
Discovery EuropeDiscovery Europe
Industry Trade Show
Not Confirmed
15-16 June, 2026
Digital content

09 Jun 2026
// FDA
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hubei-gedian-humanwell-pharmaceutical-co-ltd-725591-06032026

27 Jan 2026
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214378

27 Jan 2026
// FDA
http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214378

10 Jan 2025
// FDA

10 Jan 2025
// FDA

09 Jul 2024
// PRESS RELEASE
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27423
Submission : 2013-08-26
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43155
Submission : 2025-11-25
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37965
Submission : 2023-01-16
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-02-24
Pay. Date : 2025-02-19
DMF Number : 41062
Submission : 2025-01-26
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2022-08-03
Pay. Date : 2022-04-21
DMF Number : 34268
Submission : 2019-10-29
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-07-24
Pay. Date : 2025-07-10
DMF Number : 37957
Submission : 2023-01-18
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29764
Submission : 2015-09-20
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2021-06-24
Pay. Date : 2021-04-02
DMF Number : 26803
Submission : 2013-01-09
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27763
Submission : 2013-12-16
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-10-22
Pay. Date : 2025-09-25
DMF Number : 42435
Submission : 2025-09-19
Status : Active
Type : II

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CEP/COS
Hubei Gedian Humanwell Pharmaceutical
Certificate Numbers : CEP 2024-096 - Rev 00
Status : Valid
Issue Date : 2025-04-30
Type : Chemical
Substance Number : 372

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CEP/COS
Hubei Gedian Humanwell Pharmaceutical
Certificate Numbers : CEP 2019-295 - Rev 02
Status : Valid
Issue Date : 2024-12-17
Type : Chemical
Substance Number : 1075

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CEP/COS
Hubei Gedian Humanwell Pharmaceutical
Certificate Numbers : R1-CEP 2004-318 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2011-05-20
Type : Chemical
Substance Number : 1094

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Hubei Gedian Humanwell Pharmaceutical
Certificate Numbers : CEP 2025-414 - Rev 00
Status : Valid
Issue Date : 2025-12-08
Type : Chemical
Substance Number : 1094

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CEP/COS
Hubei Gedian Humanwell Pharmaceutical
Certificate Numbers : R1-CEP 2013-244 - Rev 01
Status : Valid
Issue Date : 2023-01-10
Type : Chemical
Substance Number : 1094

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CEP/COS
Hubei Gedian Humanwell Pharmaceutical
Certificate Numbers : CEP 2023-045 - Rev 01
Status : Valid
Issue Date : 2025-03-04
Type : Chemical
Substance Number : 2732

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Hubei Gedian Humanwell Pharmaceutical
Certificate Numbers : CEP 2020-298 - Rev 02
Status : Valid
Issue Date : 2024-12-13
Type : Chemical
Substance Number : 2641

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Hubei Gedian Humanwell Pharmaceutical
Certificate Numbers : CEP 2013-238 - Rev 01
Status : Valid
Issue Date : 2025-06-10
Type : Chemical
Substance Number : 1615

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Hubei Gedian Humanwell Pharmaceutical
Certificate Numbers : CEP 2022-199 - Rev 01
Status : Valid
Issue Date : 2025-11-13
Type : Chemical
Substance Number : 926

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CEP/COS
Hubei Gedian Humanwell Pharmaceutical
Certificate Numbers : CEP 2023-266 - Rev 02
Status : Valid
Issue Date : 2024-11-21
Type : Chemical
Substance Number : 2577

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42462
Submission : 2025-12-25
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34431
Submission : 2020-01-07
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34543
Submission : 2020-12-17
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36347
Submission : 2023-07-12
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34432
Submission : 2020-01-07
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34542
Submission : 2020-12-17
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38762
Submission : 2023-09-07
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40615
Submission : 2024-12-06
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34433
Submission : 2020-01-07
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41938
Submission : 2025-06-06
Status : Active
Type : IV

Excipients Web Link
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Inspections and registrations
Country : China
City/Region : Tianmen City
Audit Date : 2025-04-01
Audit Type : On-Site
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
Hubei Gedian Humanwell Pharmaceutical is a supplier offers 41 products (APIs, Excipients or Intermediates).
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