Company profile for AmbioPharm

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About

AmbioPharm is a global peptide CDMO founded in 2005 and headquartered in North Augusta, South Carolina, USA. It specializes in developing highly efficient manufacturing processes for peptide-based APIs at small to large scales. The company operates two cGMP-compliant manufacturing facilities, one in South Carolina, USA, and another in Shanghai, China, where it manufactures new chemical entity (NCE) peptide APIs for clients wor...
AmbioPharm is a global peptide CDMO founded in 2005 and headquartered in North Augusta, South Carolina, USA. It specializes in developing highly efficient manufacturing processes for peptide-based APIs at small to large scales. The company operates two cGMP-compliant manufacturing facilities, one in South Carolina, USA, and another in Shanghai, China, where it manufactures new chemical entity (NCE) peptide APIs for clients worldwide. Both facilities have been inspected multiple times by the FDA with positive outcomes. AmbioPharm can handle all types of peptide manufacturing, from research to cGMP.

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CONTACT DETAILS

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Country
Country
U.S.A
Address
Address
North Augusta, SC 29842
Telephone
Telephone
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YouTube

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NEWS #PharmaBuzz

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

PHARMAWEB
21 Nov 2024

https://www.businesswire.com/news/home/20231002156576/en

BUSINESSWIRE
02 Oct 2023

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

PRESS RELEASE
15 Sep 2023
AmbioPharm, a Global Peptide CDMO
AmbioPharm, a Global Peptide CDMO

25 Jul 2023

// BUSINESSWIRE

https://www.businesswire.com/news/home/20230725361937/en

BUSINESSWIRE
25 Jul 2023

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

CONTRACT PHARMA
18 May 2023

https://www.businesswire.com/news/home/20230517005511/en

BUSINESSWIRE
17 May 2023

01

Bivalirudin

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
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Bivalirudin

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Eptifibatide

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Eptifibatide

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Glatiramer Acetate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
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Glatiramer Acetate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Glucagon

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Glucagon

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Icatibant Acetate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Icatibant Acetate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Liraglutide

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
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Liraglutide

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Octreotide Acetate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Octreotide Acetate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Semaglutide

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Semaglutide

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
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Teduglutide

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Teduglutide

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
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Teriparatide Acetate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Teriparatide Acetate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
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USDMF

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BIO Partnering at JPM
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BIO Partnering at JPM
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BIO Partnering at JPM
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BIO Partnering at JPM
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BIO Partnering at JPM
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BIO Partnering at JPM
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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

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BIO Partnering at JPM
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Services

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API Manufacturing

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API & Drug Product Development

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Inspections and registrations

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FDA

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01

FDA Audited

USA
BIO Partnering at JPM
Not Confirmed
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FDA Audited

USA
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BIO Partnering at JPM
Not Confirmed

AmbioPharm

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

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FDA Audited

USA
BIO Partnering at JPM
Not Confirmed
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FDA Audited

USA
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BIO Partnering at JPM
Not Confirmed

AmbioPharm

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

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FDA Audited

USA
BIO Partnering at JPM
Not Confirmed
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FDA Audited

USA
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BIO Partnering at JPM
Not Confirmed

AmbioPharm

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

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FDA Audited

USA
BIO Partnering at JPM
Not Confirmed
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FDA Audited

USA
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BIO Partnering at JPM
Not Confirmed

AmbioPharm

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

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FDA Audited

USA
BIO Partnering at JPM
Not Confirmed
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FDA Audited

USA
arrow
BIO Partnering at JPM
Not Confirmed

AmbioPharm

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

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FDA Audited

USA
BIO Partnering at JPM
Not Confirmed
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FDA Audited

USA
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BIO Partnering at JPM
Not Confirmed

AmbioPharm

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

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FDA Audited

USA
BIO Partnering at JPM
Not Confirmed
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FDA Audited

USA
arrow
BIO Partnering at JPM
Not Confirmed

AmbioPharm

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

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ABOUT THIS PAGE

Contact AmbioPharm and get a quotation

AmbioPharm is a supplier offers 15 products (APIs, Excipients or Intermediates).

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