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Events
Webinars & Exhibitions
Industry Trade Show
Not Confirmed
24-26 February, 2026
BIO Partnering at JPMBIO Partnering at JPM
Industry Trade Show
Not Confirmed
12-15 January, 2026
Biotech ShowcaseBiotech Showcase
Industry Trade Show
Not Confirmed
12-14 January, 2026
Digital content

21 Nov 2024
// PHARMAWEB
https://www.pharmiweb.com/press-release/2024-11-21/ambiopharm-breaks-ground-on-28m-expansion-of-pharmaceutical-manufacturing-site-in-shanghai

02 Oct 2023
// BUSINESSWIRE

15 Sep 2023
// PRESS RELEASE
https://www.ambiopharm.com/news-press/combigene-selects-ambiopharm-as-peptide-cdmo-partner-for-their-cozy01-pain-project/

25 Jul 2023
// BUSINESSWIRE

18 May 2023
// CONTRACT PHARMA
https://www.contractpharma.com/contents/view_breaking-news/2023-05-18/ambiopharm-expands-south-carolina-headquarters/?widget=listSection

17 May 2023
// BUSINESSWIRE
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-30
Pay. Date : 2013-05-16
DMF Number : 20853
Submission : 2007-09-14
Status : Active
Type : II
NDC Package Code : 41524-0001
Start Marketing Date : 2011-01-19
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 : 2013-08-29
Pay. Date : 2013-05-06
DMF Number : 24864
Submission : 2011-04-18
Status : Active
Type : II
NDC Package Code : 41524-0002
Start Marketing Date : 2012-09-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-05
Pay. Date : 2014-06-09
DMF Number : 26489
Submission : 2012-09-27
Status : Active
Type : II
NDC Package Code : 41524-0004
Start Marketing Date : 2012-09-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26326
Submission : 2012-08-21
Status : Active
Type : II
NDC Package Code : 41524-0005
Start Marketing Date : 2012-09-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-30
Pay. Date : 2015-04-24
DMF Number : 29225
Submission : 2015-05-22
Status : Active
Type : II
NDC Package Code : 41524-0008
Start Marketing Date : 2017-12-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-06
Pay. Date : 2018-04-24
DMF Number : 27215
Submission : 2013-06-12
Status : Active
Type : II
NDC Package Code : 41524-0011
Start Marketing Date : 2017-12-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27759
Submission : 2013-11-21
Status : Active
Type : II
NDC Package Code : 41524-0007
Start Marketing Date : 2012-09-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-21
Pay. Date : 2021-06-10
DMF Number : 36015
Submission : 2021-08-06
Status : Active
Type : II
NDC Package Code : 41524-0012
Start Marketing Date : 2021-12-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-11-04
Pay. Date : 2016-08-01
DMF Number : 30583
Submission : 2016-08-12
Status : Active
Type : II
NDC Package Code : 41524-0009
Start Marketing Date : 2017-12-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-05
Pay. Date : 2016-11-01
DMF Number : 28464
Submission : 2017-06-01
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-30
Pay. Date : 2013-05-16
DMF Number : 20853
Submission : 2007-09-14
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-08-29
Pay. Date : 2013-05-06
DMF Number : 24864
Submission : 2011-04-18
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-06-09
DMF Number : 26489
Submission : 2012-09-27
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26326
Submission : 2012-08-21
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2015-06-30
Pay. Date : 2015-04-24
DMF Number : 29225
Submission : 2015-05-22
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26380
Submission : 2012-09-05
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2018-07-06
Pay. Date : 2018-04-24
DMF Number : 27215
Submission : 2013-06-12
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27759
Submission : 2013-11-21
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2021-09-21
Pay. Date : 2021-06-10
DMF Number : 36015
Submission : 2021-08-06
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2016-11-04
Pay. Date : 2016-08-01
DMF Number : 30583
Submission : 2016-08-12
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Services
API Manufacturing
Pharma Service : API Manufacturing
Pharma Service : API Manufacturing
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API & Drug Product Development
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-07-05
City : Beech Island
State : SC
Country/Area : U.S.A
Zip : 29842-9404
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-07-05

District Decision : No Action Indicated
Inspection End Date : 2016-01-29
City : Shanghai
State :
Country/Area : China
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2016-01-29

District Decision : Voluntary Action Indicated
Inspection End Date : 2014-10-09
City : Beech Island
State : SC
Country/Area : U.S.A
Zip : 29842-9404
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-10-09

District Decision : Voluntary Action Indicated
Inspection End Date : 2013-08-30
City : Shanghai
State :
Country/Area : China
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-08-30

District Decision : Voluntary Action Indicated
Inspection End Date : 2013-03-28
City : Beech Island
State : SC
Country/Area : U.S.A
Zip : 29842-9404
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-03-28

District Decision : No Action Indicated
Inspection End Date : 2011-08-16
City : Beech Island
State : SC
Country/Area : U.S.A
Zip : 29842-9404
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2011-08-16

District Decision : No Action Indicated
Inspection End Date : 2008-11-04
City : Beech Island
State : SC
Country/Area : U.S.A
Zip : 29842-9404
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2008-11-04

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
AmbioPharm is a supplier offers 15 products (APIs, Excipients or Intermediates).
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