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About
PEGS Boston SummitPEGS Boston Summit
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11 May-15 November, 2026
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07-10 June, 2026
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09-11 June, 2026
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Events
Webinars & Exhibitions
PEGS Boston SummitPEGS Boston Summit
Industry Trade Show
Not Confirmed
11 May-15 November, 2026
Industry Trade Show
Not Confirmed
07-10 June, 2026
Industry Trade Show
Not Confirmed
09-11 June, 2026
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43155
Submission : 2025-11-25
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-11-26
Pay. Date : 2025-09-25
DMF Number : 42497
Submission : 2025-09-22
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-04-11
Pay. Date : 2025-02-12
DMF Number : 40120
Submission : 2024-08-23
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Hubei Zhuxi Humanwell Pharmaceutical
NDC Package Code : 70492-004
Start Marketing Date : 2018-09-30
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

Hubei Zhuxi Humanwell Pharmaceutical
NDC Package Code : 70492-003
Start Marketing Date : 2018-09-26
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

Hubei Zhuxi Humanwell Pharmaceutical
NDC Package Code : 70492-002
Start Marketing Date : 2018-08-31
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PR...

Hubei Zhuxi Humanwell Pharmaceutical
NDC Package Code : 70492-006
Start Marketing Date : 2025-09-11
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

Hubei Zhuxi Humanwell Pharmaceutical
NDC Package Code : 70492-005
Start Marketing Date : 2024-05-13
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2024-12-13
Hubei Zhuxi Humanwell Pharmaceutical
City : Tianmen
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2024-12-13

District Decision : No Action Indicated
Inspection End Date : 2023-12-01
Hubei Zhuxi Humanwell Pharmaceutical
City : Shiyan
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2023-12-01

District Decision : Voluntary Action Indicated
Inspection End Date : 2016-09-22
Hubei Zhuxi Humanwell Pharmaceutical
City : Tianmen
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2016-09-22

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
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