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26-27 September, 2024
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INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/ice-is-pioneering-sustainability-innovation-in-bile-acid-research-for-neurodegenerative-diseases
VLOG #PharmaReel
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28 May 2024
// PHARMACEUTICAL TECHNOLOGY
https://www.pharmaceutical-technology.com/news/helsinn-angelini-distribution-deal/
27 May 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/05/27/2888406/0/en/Helsinn-and-Angelini-Pharma-sign-a-partnership-agreement-renewal-to-commercialize-AULIN-and-MESULID-in-Bulgaria-Czech-Republic-Hungary-Poland-Romania-and-Slovak-Republic.html
16 May 2023
// PHARMATIMES
https://www.pharmatimes.com/news/approval_provided_for_angelinis_cenobamate_1491639
12 May 2023
// Gabrielle Masson REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/italys-angelini-invests-up-506-mln-japans-jcr-epilepsy-drug-2023-05-11/
08 Dec 2022
// PRNEWSWIRE
https://www.prnewswire.com/news-releases/sk-biopharmaceuticals-partner-angelini-pharma-launches-cenobamate-in-france-301698046.html
07 Dec 2022
// BUSINESSWIRE
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-28
Pay. Date : 2019-05-15
DMF Number : 3328
Submission : 1978-06-14
Status : Active
Type : II
Certificate Number : CEP 2021-511 - Rev 01
Issue Date : 2024-03-28
Type : Chemical
Substance Number : 2857
Status : Valid
NDC Package Code : 50056-1995
Start Marketing Date : 1978-06-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : International Pharmaceutical Co., Ltd.
Registration Date : 2021-03-08
Registration Number : 20210308-209-J-580
Manufacturer Name : Aziende Chimiche Riunite Angelini Francesco Acraf SpA
Manufacturer Address : Via Guardapasso,1-04011 APRILIA (LT), Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21348
Submission : 2008-02-20
Status : Active
Type : II
NDC Package Code : 50056-2006
Start Marketing Date : 2008-02-20
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
Certificate Number : CEP 2021-203 - Rev 01
Issue Date : 2024-01-17
Type : Chemical
Substance Number : 2759
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4334
Submission : 1981-10-28
Status : Active
Type : II
NDC Package Code : 50056-2139
Start Marketing Date : 1981-10-28
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 : 2013-02-26
Pay. Date : 2013-02-11
DMF Number : 15100
Submission : 2000-10-19
Status : Active
Type : II
NDC Package Code : 50056-1999
Start Marketing Date : 2000-10-19
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
Certificate Number : R0-CEP 2023-098 - Rev 00
Issue Date : 2023-08-28
Type : Chemical
Substance Number : 2857
Status : Valid
NDC Package Code : 50056-1995
Start Marketing Date : 1978-06-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : International Pharmaceutical Co., Ltd.
Registration Date : 2021-03-08
Registration Number : 20210308-209-J-580
Manufacturer Name : Aziende Chimiche Riunite Angelini Francesco Acraf SpA
Manufacturer Address : Via Guardapasso,1-04011 APRILIA (LT), Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8372
Submission : 1989-11-22
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4314
Submission : 1981-11-09
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16014
Submission : 2002-06-20
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2652
Submission : 1976-04-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21348
Submission : 2008-02-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4334
Submission : 1981-10-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8372
Submission : 1989-11-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4314
Submission : 1981-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-11
DMF Number : 15100
Submission : 2000-10-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16014
Submission : 2002-06-20
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-28
Pay. Date : 2019-05-15
DMF Number : 3328
Submission : 1978-06-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9069
Submission : 1991-04-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2652
Submission : 1976-04-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7538
Submission : 1988-06-06
Status : Inactive
Type : II
About the Company : Angelini Fine Chemicals is Angelini Pharma S.p.A. Business Unit fully dedicated to the development and manufacture of small molecules API for the global Pharmaceutical market. Angelini Fine Che...
About the Company : Angelini Fine Chemicals is Angelini Pharma S.p.A. Business Unit fully dedicated to the development and manufacture of small molecules API for the global Pharmaceutical market. Angelini Fine Che...
About the Company : Angelini Fine Chemicals is Angelini Pharma S.p.A. Business Unit fully dedicated to the development and manufacture of small molecules API for the global Pharmaceutical market. Angelini Fine Che...
About the Company : Angelini Fine Chemicals is Angelini Pharma S.p.A. Business Unit fully dedicated to the development and manufacture of small molecules API for the global Pharmaceutical market. Angelini Fine Che...
About the Company : Angelini Fine Chemicals is Angelini Pharma S.p.A. Business Unit fully dedicated to the development and manufacture of small molecules API for the global Pharmaceutical market. Angelini Fine Che...
About the Company : Angelini Fine Chemicals is Angelini Pharma S.p.A. Business Unit fully dedicated to the development and manufacture of small molecules API for the global Pharmaceutical market. Angelini Fine Che...
About the Company : Angelini Fine Chemicals is Angelini Pharma S.p.A. Business Unit fully dedicated to the development and manufacture of small molecules API for the global Pharmaceutical market. Angelini Fine Che...
About the Company : Angelini Fine Chemicals is Angelini Pharma S.p.A. Business Unit fully dedicated to the development and manufacture of small molecules API for the global Pharmaceutical market. Angelini Fine Che...
About the Company : Angelini Fine Chemicals is Angelini Pharma S.p.A. Business Unit fully dedicated to the development and manufacture of small molecules API for the global Pharmaceutical market. Angelini Fine Che...
About the Company : Angelini Fine Chemicals is Angelini Pharma S.p.A. Business Unit fully dedicated to the development and manufacture of small molecules API for the global Pharmaceutical market. Angelini Fine Che...
Details:
Through the agreement, Angelini Pharma will focus on commercializing Mesulid (nimesulide) in Europe. It is indicated for treating patients suffering from acute pain.
Lead Product(s): Nimesulide
Therapeutic Area: Neurology Brand Name: Mesulid
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Helsinn Advanced Synthesis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 24, 2024
Lead Product(s) : Nimesulide
Therapeutic Area : Neurology
Highest Development Status : Approved
Recipient : Helsinn Advanced Synthesis
Deal Size : Undisclosed
Deal Type : Agreement
Helsinn and Angelini Renew Partnership for AULIN® and MESULID® in Central Europe
Details : Through the agreement, Angelini Pharma will focus on commercializing Mesulid (nimesulide) in Europe. It is indicated for treating patients suffering from acute pain.
Brand Name : Mesulid
Molecule Type : Small molecule
Upfront Cash : Undisclosed
May 24, 2024
Details:
The collaboration combines Angelini Pharma’s expertise in neurological diseases with JCR Pharmaceuticals’ J-Brain Cargo®, blood-brain barrier penetrating technology to develop highly innovative brain-penetrant biologic therapeutics in epilepsy.
Lead Product(s): Undisclosed
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: DiscoveryProduct Type: Large molecule
Recipient: JCR Pharmaceuticals
Deal Size: $505.5 million Upfront Cash: Undisclosed
Deal Type: Collaboration May 11, 2023
Lead Product(s) : Undisclosed
Therapeutic Area : Neurology
Highest Development Status : Discovery
Recipient : JCR Pharmaceuticals
Deal Size : $505.5 million
Deal Type : Collaboration
Details : The collaboration combines Angelini Pharma’s expertise in neurological diseases with JCR Pharmaceuticals’ J-Brain Cargo®, blood-brain barrier penetrating technology to develop highly innovative brain-penetrant biologic therapeutics in epilepsy.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Undisclosed
May 11, 2023
Details:
Cenobamate – under the brand name ONTOZRY® – has been commercialized in five major European countries such as Germany, the UK, Italy, Spain, and France, accounting for about 73 percent of the total value of the continent’s epilepsy market.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Brand Name: Ontozry
Study Phase: ApprovedProduct Type: Small molecule
Recipient: SK Biopharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2022
Lead Product(s) : Cenobamate
Therapeutic Area : Neurology
Highest Development Status : Approved
Recipient : SK Biopharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
SK Biopharmaceuticals' Partner Angelini Pharma Launches Cenobamate in France
Details : Cenobamate – under the brand name ONTOZRY® – has been commercialized in five major European countries such as Germany, the UK, Italy, Spain, and France, accounting for about 73 percent of the total value of the continent’s epilepsy market.
Brand Name : Ontozry
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 09, 2022
Details:
Ontozry (cenobamate) is a novel small molecule that provides a dual, complementary mechanism of action aimed at treatment of seizures also known as focal-onset seizures.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Brand Name: Ontozry
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Lead Product(s) : Cenobamate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Cenobamate (ONTOZRY®), for the Treatment of Uncontrolled Focal-onset Seizures in Adults, Is Now A...
Details : Ontozry (cenobamate) is a novel small molecule that provides a dual, complementary mechanism of action aimed at treatment of seizures also known as focal-onset seizures.
Brand Name : Ontozry
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 07, 2022
Details:
Pivotal trial has demonstrated that Ontozry (cenobamate) at doses of 100 mg, 200 mg, and 400 mg/day significantly improved seizure control versus placebo for adult patients with focal-onset seizures taking 1-3 ASMs.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Brand Name: Ontozry
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2022
Lead Product(s) : Cenobamate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Cenobamate (ONTOZRY®), for the Treatment of Drug-Resistant Focal-Onset Seizures in Adults, Is Now...
Details : Pivotal trial has demonstrated that Ontozry (cenobamate) at doses of 100 mg, 200 mg, and 400 mg/day significantly improved seizure control versus placebo for adult patients with focal-onset seizures taking 1-3 ASMs.
Brand Name : Ontozry
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 01, 2022
Details:
Following Angelini Pharma’s acquisition of Arvelle Therapeutics, Angelini Pharma will have the exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom).
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Brand Name: Xcopri
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Arvelle Therapeutics
Deal Size: $960.0 million Upfront Cash: $960.0 million
Deal Type: Acquisition January 04, 2021
Lead Product(s) : Cenobamate
Therapeutic Area : Neurology
Highest Development Status : Approved
Recipient : Arvelle Therapeutics
Deal Size : $960.0 million
Deal Type : Acquisition
Angelini Pharma Acquires Arvelle Therapeutics
Details : Following Angelini Pharma’s acquisition of Arvelle Therapeutics, Angelini Pharma will have the exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom).
Brand Name : Xcopri
Molecule Type : Small molecule
Upfront Cash : $960.0 million
January 04, 2021
Details:
Latuda becomes the first 2nd generation antipsychotic to be approved for patients suffering from schizophrenia as young as 13 years of age. In addition to the new indication, Latuda was also granted an additional year of marketing protection.
Lead Product(s): Lurasidone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Latuda
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Sunovion Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2020
Lead Product(s) : Lurasidone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Sunovion Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Latuda becomes the first 2nd generation antipsychotic to be approved for patients suffering from schizophrenia as young as 13 years of age. In addition to the new indication, Latuda was also granted an additional year of marketing protection.
Brand Name : Latuda
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 12, 2020
Details:
Angelini Pharma obtains exclusive development, manufacturing and commercialization rights to OV101 for the treatment of Angelman syndrome in the European Union and other countries in the European Economic Area, and also Switzerland, Turkey, the United Kingdom and Russia.
Lead Product(s): Gaboxadol
Therapeutic Area: Genetic Disease Brand Name: OV101
Study Phase: Phase IIIProduct Type: Small molecule
Recipient: Ovid Therapeutics
Deal Size: $232.0 million Upfront Cash: $20.0 million
Deal Type: Licensing Agreement July 13, 2020
Lead Product(s) : Gaboxadol
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Recipient : Ovid Therapeutics
Deal Size : $232.0 million
Deal Type : Licensing Agreement
Details : Angelini Pharma obtains exclusive development, manufacturing and commercialization rights to OV101 for the treatment of Angelman syndrome in the European Union and other countries in the European Economic Area, and also Switzerland, Turkey, the United Ki...
Brand Name : OV101
Molecule Type : Small molecule
Upfront Cash : $20.0 million
July 13, 2020
Details:
The acquired asset supports Angelini Pharma reinforcing both its Consumer Healthcare business and consolidating its International presence.
Lead Product(s): Camphor,Capsicum oleoresin,Menthol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Recipient: GSK
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition March 10, 2020
Angelini Pharma Acquires ThermaCare® From GSK
Details : The acquired asset supports Angelini Pharma reinforcing both its Consumer Healthcare business and consolidating its International presence.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
March 10, 2020
RLD : Yes
TE Code :
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OLEPTRO
Dosage Strength : 150MG **Federal Register...
Approval Date : 2010-02-02
Application Number : 22411
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET, EXTENDED RELEASE; ORAL
Proprietary Name : OLEPTRO
Dosage Strength : 300MG **Federal Register...
Approval Date : 2010-02-02
Application Number : 22411
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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ABOUT THIS PAGE
Angelini Pharma is a supplier offers 17 products (APIs, Excipients or Intermediates).
Find a price of Trazodone Hydrochloride bulk with DMF, CEP offered by Angelini Pharma
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Find a price of MFG. SITE AND FACILITIES LOCATED IN APRILIA (LT) ITALY bulk offered by Angelini Pharma
Find a price of FACILITIES IN APRILIA, ITALY bulk offered by Angelini Pharma
Find a price of Bendazac bulk offered by Angelini Pharma
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