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INTERVIEW #SpeakPharma
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08 Oct 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/en/news-release/2024/10/08/2959748/0/en/Curia-Commits-to-SBTi-Net-Zero-Standard.html
08 Oct 2024
// CONTRACTPHARMA
https://www.contractpharma.com/contents/view_breaking-news/2024-10-08/curia-commits-to-greenhouse-gas-emission-reductions/?widget=listSection
12 Aug 2024
// CONTRACT PHARMA
https://www.contractpharma.com/contents/view_breaking-news/2024-08-12/bio-x-cell-appoints-christopher-conway-ceo/72644
13 Jun 2024
// Joseph Keenan FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/cdmo-siegfried-expands-us-footprint-acquisition-wisconsin-facility
09 May 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/05/09/2878810/0/en/Curia-and-Carterra-Partner-on-Biologics-Symposium-to-Further-Biotechnology-Research-in-the-Pacific-Northwest.html
09 May 2024
// PRESS RELEASE
https://curiaglobal.com/news/curia-and-carterra-partner-on-biologics-symposium-to-further-biotechnology-research-in-the-pacific-northwest/
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-05
Pay. Date : 2015-09-24
DMF Number : 17046
Submission : 2003-12-23
Status : Active
Type : II
Certificate Number : R1-CEP 2002-031 - Rev 03
Issue Date : 2021-08-24
Type : Chemical
Substance Number : 809
Status : Valid
Registration Number : 219MF10367
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2007-12-13
Latest Date of Registration :
NDC Package Code : 65089-0009
Start Marketing Date : 1984-10-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR ...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-12-07
Pay. Date : 2023-09-27
DMF Number : 38831
Submission : 2023-09-20
Status : Active
Type : II
Certificate Number : R0-CEP 2023-167 - Rev 00
Issue Date : 2023-08-23
Type : Chemical and TSE
Substance Number : 810
Status : Valid
Registration Number : 219MF10235
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2007-07-06
Latest Date of Registration :
NDC Package Code : 65089-0004
Start Marketing Date : 1965-03-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR ...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26191
Submission : 2012-06-29
Status : Active
Type : II
Certificate Number : R1-CEP 2011-095 - Rev 01
Issue Date : 2021-08-25
Type : Chemical
Substance Number : 2127
Status : Valid
Registration Number : 222MF10016
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2010-01-07
Latest Date of Registration :
NDC Package Code : 65089-0003
Start Marketing Date : 1994-02-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR ...
Registrant Name : JDW Pharmaceutical Co., Ltd.
Registration Date : 2011-08-12
Registration Number : 20080530-93-E-56-03(5)
Manufacturer Name : Crystal Pharma, SA,
Manufacturer Address : Parque Tecnologico de Boecillo, Parcela 105, 47151-Boecillo (Valladolid), Spain
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-16
Pay. Date : 2013-12-02
DMF Number : 12949
Submission : 1998-04-13
Status : Active
Type : II
Certificate Number : R1-CEP 1999-034 - Rev 06
Issue Date : 2021-08-30
Type : Chemical
Substance Number : 994
Status : Valid
Registration Number : 218MF10617
Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy
Initial Date of Registration : 2006-07-03
Latest Date of Registration :
NDC Package Code : 55486-1567
Start Marketing Date : 2012-06-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2015-06-18
Registration Number : 20150618-18-C-338-07
Manufacturer Name : Curia Italy Srl
Manufacturer Address : Via Volturno, 41/43 - 20089 ROZZANO (MI), Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 18385
Submission : 2005-05-31
Status : Active
Type : II
Certificate Number : R1-CEP 2010-115 - Rev 03
Issue Date : 2021-11-15
Type : Chemical
Substance Number : 2359
Status : Valid
Registration Number : 227MF10011
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2015-01-05
Latest Date of Registration :
NDC Package Code : 65089-0039
Start Marketing Date : 1994-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2023-01-06
Registration Number : 20211115-209-J-1151(B)
Manufacturer Name : CURIA SPAIN SAU
Manufacturer Address : Parque Tecnológico de Boecillo, Parcela 105. 47151 Boecillo, Valladolid, Spain
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-07
Pay. Date : 2018-09-18
DMF Number : 33002
Submission : 2018-07-31
Status : Active
Type : II
Certificate Number : CEP 2018-045 - Rev 02
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 335
Status : Valid
Registration Number : 217MF10680
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2005-10-07
Latest Date of Registration :
NDC Package Code : 65089-0056
Start Marketing Date : 1982-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR ...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-30
Pay. Date : 2013-01-16
DMF Number : 14802
Submission : 2000-03-22
Status : Active
Type : II
Certificate Number : CEP 2000-107 - Rev 10
Issue Date : 2024-02-27
Type : Chemical
Substance Number : 1030
Status : Valid
Registration Number : 217MF10699
Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy
Initial Date of Registration : 2005-10-07
Latest Date of Registration :
NDC Package Code : 44657-0051
Start Marketing Date : 2010-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (30kg/30kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-21
Pay. Date : 2014-07-11
DMF Number : 10868
Submission : 1994-04-20
Status : Active
Type : II
Certificate Number : R1-CEP 2001-267 - Rev 04
Issue Date : 2021-08-11
Type : Chemical
Substance Number : 1558
Status : Valid
Registration Number : 218MF10529
Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy
Initial Date of Registration : 2006-05-18
Latest Date of Registration :
NDC Package Code : 44657-0044
Start Marketing Date : 2010-10-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
VMF Number : 5894
Submission : 2007-06-01
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12807
Submission : 1997-12-17
Status : Active
Type : II
Certificate Number : CEP 2000-049 - Rev 07
Issue Date : 2024-09-10
Type : Chemical
Substance Number : 1423
Status : Valid
NDC Package Code : 44657-0048
Start Marketing Date : 2012-03-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-17
Pay. Date : 2014-01-14
DMF Number : 15700
Submission : 2001-10-30
Status : Active
Type : II
Certificate Number : R1-CEP 2007-182 - Rev 03
Issue Date : 2021-08-11
Type : Chemical
Substance Number : 2109
Status : Valid
NDC Package Code : 44657-0076
Start Marketing Date : 2012-03-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14109
Submission : 1999-05-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12990
Submission : 1998-05-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11674
Submission : 1995-09-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11672
Submission : 1995-09-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-11
Pay. Date : 2014-02-24
DMF Number : 27982
Submission : 2014-02-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16871
Submission : 2003-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28843
Submission : 2014-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16020
Submission : 2002-06-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-03
Pay. Date : 2013-11-21
DMF Number : 17692
Submission : 2004-09-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-03
Pay. Date : 2013-11-21
DMF Number : 16019
Submission : 2002-06-21
Status : Active
Type : II
Details:
RBI-4000, is a self-replicating (srRNA) rabies vaccine, which is investigated in a Phase 1 clinical study utilizing clinical material developed as part of the collaboration with Curia.
Lead Product(s): RBI-4000
Therapeutic Area: Infections and Infectious Diseases Brand Name: RBI-4000
Study Phase: Phase IProduct Type: Vaccine
Recipient: Replicate Bioscience
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2023
Lead Product(s) : RBI-4000
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Recipient : Replicate Bioscience
Deal Size : Not Applicable
Deal Type : Not Applicable
Curia Supports Replicate Bioscience's Phase 1 Clinical Trial of Novel Next-Generation RNA Vaccine
Details : RBI-4000, is a self-replicating (srRNA) rabies vaccine, which is investigated in a Phase 1 clinical study utilizing clinical material developed as part of the collaboration with Curia.
Brand Name : RBI-4000
Molecule Type : Vaccine
Upfront Cash : Not Applicable
September 13, 2023
Details:
Murine monoclonal antibodies have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants and to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein.
Lead Product(s): Murine Monoclonal Antibody
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Large molecule
Sponsor: Tonix Pharmaceuticals Holding Corp
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 12, 2022
Lead Product(s) : Murine Monoclonal Antibody
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Tonix Pharmaceuticals Holding Corp
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Murine monoclonal antibodies have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants and to generate high affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Undisclosed
December 12, 2022
Details:
IHL-216A (cannabidiol) has been observed to have a greater neuroprotective effect in a rodent model of sports concussion than CBD, and results indicate restoration of the spatial memory deficit post-concussion with IHL-216A administration.
Lead Product(s): Cannabidiol,Isoflurane
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: IHL-216A
Study Phase: PreclinicalProduct Type: Small molecule
Recipient: Incannex Healthcare
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 02, 2022
Lead Product(s) : Cannabidiol,Isoflurane
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Preclinical
Recipient : Incannex Healthcare
Deal Size : Undisclosed
Deal Type : Agreement
Incannex Engages Curia to Scale-up Manufacture of cGMP IHL-216A
Details : IHL-216A (cannabidiol) has been observed to have a greater neuroprotective effect in a rodent model of sports concussion than CBD, and results indicate restoration of the spatial memory deficit post-concussion with IHL-216A administration.
Brand Name : IHL-216A
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 02, 2022
Details:
Denovo discovered a novel genetic biomarker for DB104 (liafensine) efficacy using its unique machine learning approach with whole genome sequencing to identify biomarkers that may be predictive of a patient's response to a specific medicine.
Lead Product(s): Liafensine
Therapeutic Area: Psychiatry/Psychology Brand Name: DB104
Study Phase: Phase IIProduct Type: Small molecule
Recipient: Denovo Biopharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2022
Lead Product(s) : Liafensine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Recipient : Denovo Biopharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Denovo discovered a novel genetic biomarker for DB104 (liafensine) efficacy using its unique machine learning approach with whole genome sequencing to identify biomarkers that may be predictive of a patient's response to a specific medicine.
Brand Name : DB104
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 28, 2022
Details:
As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials.
Lead Product(s): srRNA Therapeutic
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Large molecule
Sponsor: Replicate Bioscience
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 09, 2022
Lead Product(s) : srRNA Therapeutic
Therapeutic Area : Immunology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Replicate Bioscience
Deal Size : Undisclosed
Deal Type : Collaboration
Details : As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Undisclosed
June 09, 2022
Details:
Curia has been named as the exclusive supplier of the active pharmaceutical ingredient (API) in Cassiopea SpA’s (SIX: SKIN) recently approved acne treatment, Winlevi® (clascoterone) cream 1%.
Lead Product(s): Clascoterone
Therapeutic Area: Dermatology Brand Name: Winlevi
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Cassiopea
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 30, 2020
Lead Product(s) : Clascoterone
Therapeutic Area : Dermatology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Cassiopea
Deal Size : Undisclosed
Deal Type : Agreement
Curia Named Exclusive API Supplier for Recently Approved Acne Treatment
Details : Curia has been named as the exclusive supplier of the active pharmaceutical ingredient (API) in Cassiopea SpA’s (SIX: SKIN) recently approved acne treatment, Winlevi® (clascoterone) cream 1%.
Brand Name : Winlevi
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 30, 2020
Details:
Bryostatin-1 is the company’s lead compound being developed to improve patient outcomes by amplifying the response and increasing the durability of targeted cancer immunotherapies.
Lead Product(s): Bryostatin-1
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Small molecule
Recipient: BryoLogyx Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2020
Lead Product(s) : Bryostatin-1
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Recipient : BryoLogyx Inc
Deal Size : Not Applicable
Deal Type : Not Applicable
BryoLogyx Announces Completion of World’s First GMP Synthesis of Bryostatin-1
Details : Bryostatin-1 is the company’s lead compound being developed to improve patient outcomes by amplifying the response and increasing the durability of targeted cancer immunotherapies.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 13, 2020
Details:
Curia has been chosen to contribute to the supply of the vaccine candidate through sterile fill/finish of AZD1222 at Curia’s drug product manufacturing facility in Albuquerque, New Mexico.
Lead Product(s): ChAdOx1 nCoV-19
Therapeutic Area: Infections and Infectious Diseases Brand Name: AZD1222
Study Phase: Phase IIIProduct Type: Vaccine
Sponsor: AstraZeneca
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 03, 2020
Lead Product(s) : ChAdOx1 nCoV-19
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Undisclosed
Deal Type : Agreement
Curia Selected to Support AstraZeneca in Delivery of COVID-19 Vaccine
Details : Curia has been chosen to contribute to the supply of the vaccine candidate through sterile fill/finish of AZD1222 at Curia’s drug product manufacturing facility in Albuquerque, New Mexico.
Brand Name : AZD1222
Molecule Type : Vaccine
Upfront Cash : Undisclosed
September 03, 2020
Details:
Curia will provide research, development and cGMP manufacturing of a proprietary psilocybin active pharmaceutical ingredient to support the clinical development of TRP-8802, TRP-8803 and TRP-8804 programs.
Lead Product(s): Psilocybine
Therapeutic Area: Psychiatry/Psychology Brand Name: TRP-8802
Study Phase: UndisclosedProduct Type: Small molecule
Sponsor: Tryp Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 13, 2020
Lead Product(s) : Psilocybine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Tryp Therapeutics
Deal Size : Undisclosed
Deal Type : Partnership
Tryp Therapeutics Partners with Curia to Manufacture a Proprietary Psilocybin-based Drug
Details : Curia will provide research, development and cGMP manufacturing of a proprietary psilocybin active pharmaceutical ingredient to support the clinical development of TRP-8802, TRP-8803 and TRP-8804 programs.
Brand Name : TRP-8802
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 13, 2020
Details:
The companies together are undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a stand-alone treatment or in combination with other antiviral agents or immune modulators.
Lead Product(s): Merimepodib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Brand Name: VX-497
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: BioSig Technologies
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 08, 2020
Lead Product(s) : Merimepodib,Remdesivir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : BioSig Technologies
Deal Size : Undisclosed
Deal Type : Partnership
ViralClear, Curia Enter COVID-19 Partnership
Details : The companies together are undertaking research to investigate the potential of merimepodib to fight SARS-CoV-2, the virus that causes COVID-19, either as a stand-alone treatment or in combination with other antiviral agents or immune modulators.
Brand Name : VX-497
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 08, 2020
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Curia is a supplier offers 168 products (APIs, Excipients or Intermediates).
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