15 Jul 2024
// PRESS RELEASE
24 Jun 2024
// PRESS RELEASE
10 May 2024
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Latest Content by PharmaCompass
AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.
About
CPhI Worldwide, MilanCPhI Worldwide, Milan
Industry Trade Show
Booth #7F2
08-10 October, 2024
Bio-Europe 2024Bio-Europe 2024
Industry Trade Show
Attending
04-06 November, 2024
Industry Trade Show
Not Confirmed
26-27 September, 2024
CONTACT DETAILS
Events
Webinars & Exhibitions
CPhI Worldwide, MilanCPhI Worldwide, Milan
Industry Trade Show
Booth #7F2
08-10 October, 2024
Bio-Europe 2024Bio-Europe 2024
Industry Trade Show
Attending
04-06 November, 2024
Industry Trade Show
Not Confirmed
26-27 September, 2024
CORPORATE CONTENT #SupplierSpotlight
https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-novo-s-parent-buys-catalent-for-us-16-5-bn-fujifilm-merck-kgaa-axplora-lonza-expand-capabilities
https://www.pharmacompass.com/radio-compass-blog/ophthalmic-dealmakers-novartis-abbvie-forge-deals-to-develop-ocular-gene-therapies
15 Jul 2024
// PRESS RELEASE
https://www.abbviecontractmfg.com/news-and-insights/success-factors-for-pre-filled-syringe-cmo-selection.html
24 Jun 2024
// PRESS RELEASE
https://www.abbviecontractmfg.com/news-and-insights/how-abbvie-operations-and-contract-manufacturing-has-prepared-global-parenteral-sites-for-the-annex-1-compliance-requirement.html
10 May 2024
// PRESS RELEASE
https://www.abbviecontractmfg.com/news-and-insights/translating-environmental-social-and-governance-esg-benefits-to-our-partners.html
20 Mar 2024
// PRESS RELEASE
https://www.abbviecontractmfg.com/news-and-insights/AbbVie-Contract-Manufacturing-12-Time-CMO-Leadership-Award-Winner.html#:~:text=AbbVie%20Contract%20Manufacturing%20%E2%80%93%2012%2DTime%20CMO%20Leadership%20Award%20Winner&text=AbbVie%20Contract%20Manufacturing%20has%20been,industry%20research%20and%20customer%20surveys.
11 Mar 2024
// PRESS RELEASE
https://www.abbviecontractmfg.com/news-and-insights/abbvie-contract-manufacturing-recognized-by-life-science-leader-for-the-11th-year.html
18 Jan 2024
// PRESS RELEASE
https://www.abbviecontractmfg.com/news-and-insights/Four-Myths-About-Embedded-CMOs-Busted.html
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13800
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1998-093 - Rev 07
Issue Date : 2020-10-09
Type : Chemical and TSE
Substance Number : 994
Status : Valid
NDC Package Code : 0074-5503
Start Marketing Date : 2010-05-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-18-C-100-05
Manufacturer Name : AbbVie Inc.
Manufacturer Address : 1401 Sheridan Road, North Chicago, IL, 60064-4000, USA
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13197
Submission : 1998-04-30
Status : Active
Type : II
Certificate Number : R1-CEP 2016-267 - Rev 00
Issue Date : 2022-03-14
Type : Chemical
Substance Number : 179
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-09
Pay. Date : 2013-09-25
DMF Number : 27155
Submission : 2015-11-10
Status : Active
Type : II
Certificate Number : R1-CEP 1997-001 - Rev 08
Issue Date : 2023-05-23
Type : Chemical
Substance Number : 179
Status : Valid
Certificate Number : R2-CEP 1995-038 - Rev 05
Issue Date : 2019-01-24
Type : Chemical
Substance Number : 1074
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8904
Submission : 1990-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13443
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13372
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 2006-292 - Rev 00
Issue Date : 2012-09-24
Type : Chemical
Substance Number : 1673
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24315
Submission : 2010-11-30
Status : Active
Type : II
NDC Package Code : 68513-1054
Start Marketing Date : 2011-09-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2012-397 - Rev 00
Issue Date : 2019-09-19
Type : Chemical
Substance Number : 2136
Status : Valid
Details:
Tepkinly (epcoritamab) is an IgG1-bispecific antibody, which is approved for the treatment of relapsed/refractory follicular lymphoma. It is designed to direct cytotoxic T cells selectively.
Lead Product(s): Epcoritamab
Therapeutic Area: Oncology Brand Name: Tepkinly
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Genmab
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2024
TEPKINLY® Receives Second EU Approval for Relapsed/Refractory Follicular Lymphoma
Details : Tepkinly (epcoritamab) is an IgG1-bispecific antibody, which is approved for the treatment of relapsed/refractory follicular lymphoma. It is designed to direct cytotoxic T cells selectively.
Brand Name : Tepkinly
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 19, 2024
Details:
Through the acquisition, Abbvie will leverage the Cerevel pipeline, which includes CVL-75 (tavapadon), a late-stage product, D1/D5 selective partial agonist for the treatment of Parkinson's disease.
Lead Product(s): Tavapadon
Therapeutic Area: Neurology Brand Name: CVL-751
Study Phase: Phase IIIProduct Type: Small molecule
Recipient: Cerevel Therapeutics
Deal Size: $8,700.0 million Upfront Cash: $8,700.0 million
Deal Type: Acquisition August 01, 2024
Lead Product(s) : Tavapadon
Therapeutic Area : Neurology
Highest Development Status : Phase III
Recipient : Cerevel Therapeutics
Deal Size : $8,700.0 million
Deal Type : Acquisition
AbbVie Completes Acquisition of Cerevel Therapeutics
Details : Through the acquisition, Abbvie will leverage the Cerevel pipeline, which includes CVL-75 (tavapadon), a late-stage product, D1/D5 selective partial agonist for the treatment of Parkinson's disease.
Brand Name : CVL-751
Molecule Type : Small molecule
Upfront Cash : $8,700.0 million
August 01, 2024
Details:
Skyrizi (risankizumab) is an interleukin-23 antagonist. It is now approved for the treatment of adults with moderately to severely active ulcerative colitis in Europe.
Lead Product(s): Risankizumab
Therapeutic Area: Gastroenterology Brand Name: Skyrizi
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2024
Lead Product(s) : Risankizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
AbbVie Announces EC Approval of SKYRIZI for Moderate to Severe Active Ulcerative Colitis
Details : Skyrizi (risankizumab) is an interleukin-23 antagonist. It is now approved for the treatment of adults with moderately to severely active ulcerative colitis in Europe.
Brand Name : Skyrizi
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 26, 2024
Details:
Under the partnership, the companies will collaborate on the research and pre-clinical development of programs directed to novel E3 ligases, and certain immunology and oncology targets.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Small molecule
Recipient: Frontier Medicine
Deal Size: $1,000.0 million Upfront Cash: Undisclosed
Deal Type: Partnership July 23, 2024
Lead Product(s) : Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Phase III
Recipient : Frontier Medicine
Deal Size : $1,000.0 million
Deal Type : Partnership
Frontier Announces Milestone Payment in AbbVie Partnership for Advancing Lead Candidates
Details : Under the partnership, the companies will collaborate on the research and pre-clinical development of programs directed to novel E3 ligases, and certain immunology and oncology targets.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 23, 2024
Details:
Under the terms of the agreement, Sionna will assume all development for ABBV-2222 (galicaftor), which is being evaluated in combination with navocaftor for the treatment of Cystic Fibrosis.
Lead Product(s): Galicaftor,Navocaftor
Therapeutic Area: Genetic Disease Brand Name: ABBV-2222
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Sionna Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 16, 2024
Lead Product(s) : Galicaftor,Navocaftor
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Sionna Therapeutics
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Sionna Expands CF Pipeline with AbbVie License Agreement
Details : Under the terms of the agreement, Sionna will assume all development for ABBV-2222 (galicaftor), which is being evaluated in combination with navocaftor for the treatment of Cystic Fibrosis.
Brand Name : ABBV-2222
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 16, 2024
Details:
Tepkinly (epcoritamab) is an IgG1-bispecific antibody, which is approved for the treatment of relapsed/refractory follicular lymphoma. It is designed to direct cytotoxic T cells selectively.
Lead Product(s): Epcoritamab
Therapeutic Area: Oncology Brand Name: Tepkinly
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Genmab
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2024
Epcoritamab (TEPKINLY®) Receives Positive CHMP Opinion for the Treatment of Adults with Relapsed/...
Details : Tepkinly (epcoritamab) is an IgG1-bispecific antibody, which is approved for the treatment of relapsed/refractory follicular lymphoma. It is designed to direct cytotoxic T cells selectively.
Brand Name : Tepkinly
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 28, 2024
Details:
The Celsius Therapeutics acquisition will add CEL383, a potential first-in-class anti-Triggering Receptor Expressed on Myeloid Cells 1 antibody for inflammatory bowel disease, to AbbVie's portfolio.
Lead Product(s): CEL383
Therapeutic Area: Immunology Brand Name: CEL383
Study Phase: Phase IProduct Type: Large molecule
Recipient: Celsius Therapeutics
Deal Size: $250.0 million Upfront Cash: $250.0 million
Deal Type: Acquisition June 27, 2024
Lead Product(s) : CEL383
Therapeutic Area : Immunology
Highest Development Status : Phase I
Recipient : Celsius Therapeutics
Deal Size : $250.0 million
Deal Type : Acquisition
AbbVie Acquires Celsius Therapeutics
Details : The Celsius Therapeutics acquisition will add CEL383, a potential first-in-class anti-Triggering Receptor Expressed on Myeloid Cells 1 antibody for inflammatory bowel disease, to AbbVie's portfolio.
Brand Name : CEL383
Molecule Type : Large molecule
Upfront Cash : $250.0 million
June 27, 2024
Details:
The collaboration aims to leverage Nxera’s NxWave platform to discover and commercialize new medicines targeting novel G protein-coupled receptor targets associated with neurological disease.
Lead Product(s): Undisclosed
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Discovery PlatformProduct Type: Small molecule
Recipient: Sosei Group Corporation
Deal Size: $1,200.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration June 26, 2024
Lead Product(s) : Undisclosed
Therapeutic Area : Neurology
Highest Development Status : Discovery Platform
Recipient : Sosei Group Corporation
Deal Size : $1,200.0 million
Deal Type : Collaboration
Nxera Receives US$10 Million from AbbVie for Neurological Diseases Milestone
Details : The collaboration aims to leverage Nxera’s NxWave platform to discover and commercialize new medicines targeting novel G protein-coupled receptor targets associated with neurological disease.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 26, 2024
Details:
Epkinly (epcoritamab) is an IgG1-bispecific antibody, which is approved for the treatment of relapsed/refractory follicular lymphoma. It is designed to direct cytotoxic T cells selectively.
Lead Product(s): Epcoritamab
Therapeutic Area: Oncology Brand Name: Epkinly
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Genmab
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 26, 2024
FDA Approves EPKINLY® for Relapsed or Refractory Follicular Lymphoma
Details : Epkinly (epcoritamab) is an IgG1-bispecific antibody, which is approved for the treatment of relapsed/refractory follicular lymphoma. It is designed to direct cytotoxic T cells selectively.
Brand Name : Epkinly
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 26, 2024
Details:
ABBV-951 (foslevodopa/foscarbidopa) is a subcutaneous treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia.
Lead Product(s): Foslevodopa,Foscarbidopa
Therapeutic Area: Neurology Brand Name: ABBV-951
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2024
Lead Product(s) : Foslevodopa,Foscarbidopa
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)
Details : ABBV-951 (foslevodopa/foscarbidopa) is a subcutaneous treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia.
Brand Name : ABBV-951
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 25, 2024
RLD : No
TE Code :
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Dosage Form : TABLET; ORAL
Proprietary Name : VICODIN HP
Dosage Strength : 660MG;10MG
Approval Date : 1996-09-23
Application Number : 40117
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Dosage Form : TABLET; ORAL
Proprietary Name : VICODIN
Dosage Strength : 500MG;5MG
Approval Date : 1983-01-07
Application Number : 88058
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Dosage Form : TABLET; ORAL
Proprietary Name : VICODIN ES
Dosage Strength : 750MG;7.5MG
Approval Date : 1988-12-09
Application Number : 89736
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : ACYCLOVIR
Dosage Strength : EQ 50MG BASE/ML
Approval Date : 1999-07-26
Application Number : 75114
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD :
TE Code :
Dosage Form : SYRINGE
Proprietary Name : HUMIRA
Dosage Strength : 40MG/0.8ML
Approval Date :
Application Number : 125057
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Dosage Form : VIAL
Proprietary Name : HUMIRA
Dosage Strength : 40MG/0.8ML
Approval Date :
Application Number : 125057
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Dosage Form : SOLUTION/DROPS; OPHTHALMIC
Proprietary Name : LASTACAFT
Dosage Strength : 0.25%
Approval Date : 2010-07-28
Application Number : 22134
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :
RLD : Yes
TE Code : AB
Dosage Form : TABLET; SUBLINGUAL
Proprietary Name : SAPHRIS
Dosage Strength : EQ 5MG BASE
Approval Date : 2009-08-13
Application Number : 22117
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Dosage Form : TABLET; SUBLINGUAL
Proprietary Name : SAPHRIS
Dosage Strength : EQ 10MG BASE
Approval Date : 2009-08-13
Application Number : 22117
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Dosage Form : TABLET; SUBLINGUAL
Proprietary Name : SAPHRIS
Dosage Strength : EQ 2.5MG BASE
Approval Date : 2015-03-12
Application Number : 22117
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
Services
API Manufacturing
Drug Product Manufacturing
Pharma Service : Drug Product Manufacturing
Pharma Service : Drug Product Manufacturing
Pharma Service : Drug Product Manufacturing
Category : Lyophilization
Sub Category : Overview
Pharma Service : Drug Product Manufacturing
API & Drug Product Development
Packaging
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2020-01-10
City : Grayslake
State : IL
Country/Area : US
Zip : 60030-3910
District : CHI
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2020-01-10
District Decision : Voluntary Action Indicated
Inspection End Date : 2019-03-25
City : Barceloneta
State : PR
Country/Area : US
Zip : 00617
District : SJN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2019-03-25
District Decision : Voluntary Action Indicated
Inspection End Date : 2018-06-01
City : Barceloneta
State : PR
Country/Area : US
Zip : 00617
District : SJN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2018-06-01
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-04-28
City : Barceloneta
State : PR
Country/Area : US
Zip : 00617
District : SJN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-04-28
District Decision : Voluntary Action Indicated
Inspection End Date : 2016-03-24
City : Barceloneta
State : PR
Country/Area : US
Zip : 00617
District : SJN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2016-03-24
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-07-16
City : Barceloneta
State : PR
Country/Area : US
Zip : 00617
District : SJN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-07-16
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-07-12
City : Barceloneta
State : PR
Country/Area : US
Zip : 00617
District : SJN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-07-12
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-04-29
City : Barceloneta
State : PR
Country/Area : US
Zip : 00617
District : SJN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-04-29
District Decision : No Action Indicated
Inspection End Date : 2009-03-04
City : Barceloneta
State : PR
Country/Area : US
Zip : 00617
District : SJN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2009-03-04
District Decision : No Action Indicated
Inspection End Date : 2019-11-18
City : Worcester
State : MA
Country/Area : US
Zip : 01605-4312
District : NWE
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2019-11-18
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