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CPhI India 2024CPhI India 2024
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26-28 November, 2024
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11-14 November, 2024
The Pharmacy Technolog...The Pharmacy Technology
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11-13 November, 2024
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Events
Webinars & Exhibitions
CPhI India 2024CPhI India 2024
Industry Trade Show
Not Confirmed
26-28 November, 2024
Industry Trade Show
Not Confirmed
11-14 November, 2024
The Pharmacy Technolog...The Pharmacy Technology
Industry Trade Show
Not Confirmed
11-13 November, 2024
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/lgm-pharma-has-made-significant-strides-in-meeting-the-evolving-needs-of-its-clients
VLOG #PharmaReel
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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
25 Apr 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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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
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
NDC Package Code : 41524-0001
Start Marketing Date : 2011-01-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 41524-0013
Start Marketing Date : 2021-12-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 41524-0002
Start Marketing Date : 2012-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 41524-0003
Start Marketing Date : 2012-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 41524-0004
Start Marketing Date : 2012-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 41524-0005
Start Marketing Date : 2012-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 41524-0008
Start Marketing Date : 2017-12-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 41524-0006
Start Marketing Date : 2012-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 41524-0011
Start Marketing Date : 2017-12-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 41524-0007
Start Marketing Date : 2012-09-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Details:
The OK-101 drug candidate displays potent anti-inflammatory activity in animal models of DED. OK-101 also reduces Corneal Neuropathic Pain (CNP) in a ciliary nerve ligation animal model of CNP.
Lead Product(s): OK-101
Therapeutic Area: Ophthalmology Brand Name: OK-101
Study Phase: PreclinicalProduct Type: Small molecule
Recipient: OKYO Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2022
Lead Product(s) : OK-101
Therapeutic Area : Ophthalmology
Highest Development Status : Preclinical
Recipient : OKYO Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The OK-101 drug candidate displays potent anti-inflammatory activity in animal models of DED. OK-101 also reduces Corneal Neuropathic Pain (CNP) in a ciliary nerve ligation animal model of CNP.
Brand Name : OK-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 30, 2022
Details:
Amytrx has identified new opportunities for other inflammatory and metabolic diseases with attractive out-licensing and collaborative opportunities using its proprietary AMTX-100 human peptide platform.
Lead Product(s): AMTX-100
Therapeutic Area: Dermatology Brand Name: AMTX-100
Study Phase: Phase I/ Phase IIProduct Type: Peptide
Recipient: Amytrx Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 26, 2022
Lead Product(s) : AMTX-100
Therapeutic Area : Dermatology
Highest Development Status : Phase I/ Phase II
Recipient : Amytrx Therapeutics
Deal Size : Undisclosed
Deal Type : Partnership
Details : Amytrx has identified new opportunities for other inflammatory and metabolic diseases with attractive out-licensing and collaborative opportunities using its proprietary AMTX-100 human peptide platform.
Brand Name : AMTX-100
Molecule Type : Peptide
Upfront Cash : Undisclosed
July 26, 2022
Details:
ONL1204 Ophthalmic Solution is a novel, first-in-class small peptide Fas inhibitor designed to protect key retinal cells, including photoreceptors, from cell death that occurs in a range of retinal diseases and conditions.
Lead Product(s): ONL1204
Therapeutic Area: Ophthalmology Brand Name: ONL1204
Study Phase: IND EnablingProduct Type: Small molecule
Sponsor: ONL Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2022
Lead Product(s) : ONL1204
Therapeutic Area : Ophthalmology
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : ONL Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ONL1204 Ophthalmic Solution is a novel, first-in-class small peptide Fas inhibitor designed to protect key retinal cells, including photoreceptors, from cell death that occurs in a range of retinal diseases and conditions.
Brand Name : ONL1204
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 12, 2022
Details:
Icatibant, a complex injectable peptide product, forming part of high-value product, is an equivalent and more affordable version of Firazyr (Takeda/Shire), used used to treat a serious orphan disease, acute attacks of hereditary angioedema.
Lead Product(s): Icatibant Acetate
Therapeutic Area: Genetic Disease Brand Name: Icatibant Acetate-Generic
Study Phase: ApprovedProduct Type: Peptide
Recipient: Adalvo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
Lead Product(s) : Icatibant Acetate
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Recipient : Adalvo
Deal Size : Not Applicable
Deal Type : Not Applicable
Adalvo Announces Successful DCP Closure for Icatibant
Details : Icatibant, a complex injectable peptide product, forming part of high-value product, is an equivalent and more affordable version of Firazyr (Takeda/Shire), used used to treat a serious orphan disease, acute attacks of hereditary angioedema.
Brand Name : Icatibant Acetate-Generic
Molecule Type : Peptide
Upfront Cash : Not Applicable
September 28, 2021
Details:
Researchers have utilized a venom peptide originally isolated from the Peruvian green velvet tarantula (Thrixopelma pruriens) that blocks Nav1.7 voltage-gated ion channels, an ion channel important in pain signaling.
Lead Product(s): Thrixopelma pruriens venom peptide
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Peptide
Recipient: University of California
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2021
Lead Product(s) : Thrixopelma pruriens venom peptide
Therapeutic Area : Neurology
Highest Development Status : Undisclosed
Recipient : University of California
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Researchers have utilized a venom peptide originally isolated from the Peruvian green velvet tarantula (Thrixopelma pruriens) that blocks Nav1.7 voltage-gated ion channels, an ion channel important in pain signaling.
Brand Name : Undisclosed
Molecule Type : Peptide
Upfront Cash : Not Applicable
July 20, 2021
Details:
AmbioPharm will manufacture the active pharmaceutical ingredient exclusively for Upsher-Smith. A contract manufacturing organization will exclusively supply Upsher-Smith with the finished product for sale in the United States.
Lead Product(s): Corticotropin
Therapeutic Area: Neurology Brand Name: Acthar
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Upsher-Smith Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 07, 2020
Lead Product(s) : Corticotropin
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Upsher-Smith Laboratories
Deal Size : Undisclosed
Deal Type : Partnership
Details : AmbioPharm will manufacture the active pharmaceutical ingredient exclusively for Upsher-Smith. A contract manufacturing organization will exclusively supply Upsher-Smith with the finished product for sale in the United States.
Brand Name : Acthar
Molecule Type : Peptide
Upfront Cash : Undisclosed
August 07, 2020
Details:
The partnership includes a basket of difficult-to-make peptide products that will be used to treat various diseases, ranging from diabetes to immunology disorders, cardiologic and endocrinology diseases.
Lead Product(s): Undisclosed
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Peptide
Recipient: Adalvo
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 29, 2020
Lead Product(s) : Undisclosed
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Recipient : Adalvo
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Adalvo and AmbioPharm Partner on Development & Licensing for Key Peptide Product
Details : The partnership includes a basket of difficult-to-make peptide products that will be used to treat various diseases, ranging from diabetes to immunology disorders, cardiologic and endocrinology diseases.
Brand Name : Undisclosed
Molecule Type : Peptide
Upfront Cash : Undisclosed
July 29, 2020
Services
API Manufacturing
Pharma Service : API Manufacturing
Pharma Service : API Manufacturing
Pharma Service : API Manufacturing
Category : GMP Manufacturing
Sub Category : Overview
Pharma Service : API Manufacturing
Pharma Service : API Manufacturing
Category : Protein / Peptide
Sub Category : Overview
Pharma Service : API Manufacturing
Pharma Service : API Manufacturing
Category : Protein / Peptide
Sub Category : Synthesis
Pharma Service : API Manufacturing
API & Drug Product Development
Pharma Service : API & Drug Product Development
Category : API Development
Sub Category : Protein / Peptide
Pharma Service : API & Drug Product Development
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2008-11-04
City : Beech Island
State : SC
Country/Area : US
Zip : 29842-9404
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2008-11-04
District Decision : No Action Indicated
Inspection End Date : 2011-08-16
City : Beech Island
State : SC
Country/Area : US
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 : Voluntary Action Indicated
Inspection End Date : 2013-03-28
City : Beech Island
State : SC
Country/Area : US
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 : Voluntary Action Indicated
Inspection End Date : 2014-10-09
City : Beech Island
State : SC
Country/Area : US
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 : 2017-07-05
City : Beech Island
State : SC
Country/Area : US
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 : CN
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 : 2013-08-30
City : Shanghai
State :
Country/Area : CN
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-08-30
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : Shanghai AmbioPharm, Inc.
Business Address : Shanghai AmbioPharm, Inc. N...
FEI Number : 3006494603
Country : U.S.A
Paid in : 2021
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : AmbioPharm, Inc.
Business Address : 1024 Dittman Court North Aug...
FEI Number : 3006446551
Country : U.S.A
Paid in : 2021
ABOUT THIS PAGE
AmbioPharm is a supplier offers 11 products (APIs, Excipients or Intermediates).
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