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11-14 November, 2024
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11-13 November, 2024
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CPhI India 2024CPhI India 2024
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26-28 November, 2024
Industry Trade Show
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11-14 November, 2024
The Pharmacy Technolog...The Pharmacy Technology
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11-13 November, 2024
Digital content
INTERVIEW #SpeakPharma
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06 Nov 2024
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-6-2024-85888.pdf
23 Oct 2024
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-23-2024-21885.pdf
19 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/accord-healthcare-receives-positive-chmp-opinion-for-imuldosa-a-ustekinumab-biosimilar-to-stelara-302280374.html
21 Sep 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/henlius-and-intas-receive-positive-chmp-opinion-for-hetronifly-approved-as-hansizhuang-in-china-in-european-markets-as-first-line-treatment-for-adult-patients-with-extensive-stage-small-cell-lung-cancer-302254345.html
30 Apr 2024
// PHARMACEUTICAL TECHNOLOGY
https://www.pharmaceutical-technology.com/news/accord-biopharma-hercessi-fda/
10 Apr 2024
// FDA
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-23
Pay. Date : 2013-12-31
DMF Number : 27839
Submission : 2014-01-06
Status : Active
Type : II
Certificate Number : R1-CEP 2017-149 - Rev 00
Issue Date : 2023-07-07
Type : Chemical
Substance Number : 2777
Status : Valid
Date of Issue : 2022-02-02
Valid Till : 2025-03-04
Written Confirmation Number : WC-0440
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-22
Pay. Date : 2020-01-20
DMF Number : 34545
Submission : 2020-01-27
Status : Active
Type : II
Certificate Number : CEP 2012-367 - Rev 02
Issue Date : 2024-03-20
Type : Chemical
Substance Number : 714
Status : Valid
Date of Issue : 2020-06-23
Valid Till : 2023-10-05
Written Confirmation Number : WC-0357
Address of the Firm :
Registrant Name : Ildong Pharmaceutical Co., Ltd.
Registration Date : 2021-04-22
Registration Number : 20201116-210-J-443(3)
Manufacturer Name : Intas pharmaceutical limited
Manufacturer Address : 2702/A, GIDC Estate, Ankleshwar-393 002, Dist: Bharuch, Gujarat, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-19
Pay. Date : 2016-05-25
DMF Number : 30562
Submission : 2016-06-08
Status : Active
Type : II
Certificate Number : R0-CEP 2020-178 - Rev 00
Issue Date : 2022-09-06
Type : Chemical
Substance Number : 2932
Status : Valid
Date of Issue : 2022-01-05
Valid Till : 2022-03-04
Written Confirmation Number : WC-0440A2
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-20
Pay. Date : 2013-12-27
DMF Number : 27821
Submission : 2013-12-30
Status : Active
Type : II
Date of Issue : 2022-02-02
Valid Till : 2025-03-04
Written Confirmation Number : WC-0440
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24370
Submission : 2010-11-09
Status : Active
Type : II
Certificate Number : R1-CEP 2015-325 - Rev 01
Issue Date : 2022-06-24
Type : Chemical
Substance Number : 2762
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28756
Submission : 2014-10-29
Status : Active
Type : II
Certificate Number : CEP 2020-155 - Rev 01
Issue Date : 2024-09-26
Type : Chemical
Substance Number : 2593
Status : Valid
Registrant Name : Myungmoon Pharmaceutical Co., Ltd.
Registration Date : 2021-01-13
Registration Number : 20210113-210-J-821
Manufacturer Name : Intas Pharmaceuticals Limited
Manufacturer Address : Plot No. 457 & 458, Village Matoda, Bavla road and Plot No. 191/218 P, Village Chacharwadi, Taluka–Sanand 382210, District - Ahmedabad, State India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-28
Pay. Date : 2014-06-18
DMF Number : 28387
Submission : 2014-06-24
Status : Active
Type : II
Certificate Number : R0-CEP 2020-090 - Rev 01
Issue Date : 2023-07-05
Type : Chemical
Substance Number : 2988
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22748
Submission : 2009-04-15
Status : Active
Type : II
Certificate Number : CEP 2022-092 - Rev 01
Issue Date : 2024-09-02
Type : Chemical
Substance Number : 2306
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-08
Pay. Date : 2012-10-26
DMF Number : 26520
Submission : 2012-10-19
Status : Active
Type : II
Certificate Number : R0-CEP 2018-247 - Rev 01
Issue Date : 2022-06-27
Type : Chemical
Substance Number : 2992
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-07
Pay. Date : 2013-01-10
DMF Number : 26792
Submission : 2013-01-17
Status : Active
Type : II
Certificate Number : R0-CEP 2021-455 - Rev 00
Issue Date : 2022-04-08
Type : Chemical
Substance Number : 1794
Status : Valid
Details:
Imuldosa (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. It is indicated for the treatment of moderate to severe plague psoriasis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Brand Name: Imuldosa
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Accord Gets Positive CHMP Opinion for Stelara® Biosimilar IMULDOSA®
Details : Imuldosa (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. It is indicated for the treatment of moderate to severe plague psoriasis.
Brand Name : Imuldosa
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 19, 2024
Details:
Hetronifly (serplulimab) is a PD-1 inhibitor antibody, which is currently being evaluated for the treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer.
Lead Product(s): Serplulimab
Therapeutic Area: Oncology Brand Name: Hetronifly
Study Phase: Phase IIIProduct Type: Large molecule
Recipient: Henlius
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2024
Henlius, Intas Get CHMP Nod for HETRONIFLY® in Small Cell Lung Cancer
Details : Hetronifly (serplulimab) is a PD-1 inhibitor antibody, which is currently being evaluated for the treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer.
Brand Name : Hetronifly
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 21, 2024
Details:
DMB-3115 (ustekinumab-biosimilar) is an IL-12/23 inhibitor which is being evaluated in phase 3 clinical trials for the treatment of patients with moderate-to-severe chronic plaque psoriasis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Brand Name: DMB-3115
Study Phase: Phase IIIProduct Type: Large molecule
Recipient: Accord BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Recipient : Accord BioPharma
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Accepts BLA for Dong-A ST's DMB-3115, a Proposed Biosimilar to Stelara
Details : DMB-3115 (ustekinumab-biosimilar) is an IL-12/23 inhibitor which is being evaluated in phase 3 clinical trials for the treatment of patients with moderate-to-severe chronic plaque psoriasis.
Brand Name : DMB-3115
Molecule Type : Large molecule
Upfront Cash : Not Applicable
January 05, 2024
Details:
Under the agreement, Intas receives exclusive rights to commercialise Etanercept biosimilars, through its affiliates, for the treatment of various autoimmune diseases, in more than 150 countries across the globe, including Europe and the United States of America.
Lead Product(s): Etanercept
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Large molecule
Recipient: Mabxience
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 20, 2023
Lead Product(s) : Etanercept
Therapeutic Area : Immunology
Highest Development Status : Undisclosed
Recipient : Mabxience
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under the agreement, Intas receives exclusive rights to commercialise Etanercept biosimilars, through its affiliates, for the treatment of various autoimmune diseases, in more than 150 countries across the globe, including Europe and the United States of...
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Undisclosed
December 20, 2023
Details:
Tecfidera-Generic (dimethyl fumarate) is an oral Nuclear factor erythroid-derived 2 (Nrf2) pathway activator. It is approved for the treatment of patients with relapsing forms of multiple sclerosis.
Lead Product(s): Dimethyl Fumarate
Therapeutic Area: Neurology Brand Name: Tecfidera-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the Europea...
Details : Tecfidera-Generic (dimethyl fumarate) is an oral Nuclear factor erythroid-derived 2 (Nrf2) pathway activator. It is approved for the treatment of patients with relapsing forms of multiple sclerosis.
Brand Name : Tecfidera-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 19, 2023
Details:
Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing and supply upon launch of specific formulation of HANSIZHUANG (serplulimab injection), Henlius' novel anti-PD-1 mAb.
Lead Product(s): Serplulimab,Fluorouracil
Therapeutic Area: Oncology Brand Name: Hansizhuang
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Henlius
Deal Size: $195.5 million Upfront Cash: $44.4 million
Deal Type: Collaboration October 27, 2023
Lead Product(s) : Serplulimab,Fluorouracil
Therapeutic Area : Oncology
Highest Development Status : Approved
Recipient : Henlius
Deal Size : $195.5 million
Deal Type : Collaboration
Details : Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing and supply upon launch of specific formulation of HANSIZHUANG (serplulimab injection), Henlius' novel anti-PD-1 mAb.
Brand Name : Hansizhuang
Molecule Type : Large molecule
Upfront Cash : $44.4 million
October 27, 2023
Details:
The agreement aims for the commercialisation of HIPRA's mRNA COVID-19 vaccine, Bimervax, which combines a part of the SARS-CoV-2 virus spike protein with an adjuvant, in the United Kingdom.
Lead Product(s): Recombinant, Adjuvanted Covid-19 Vaccine
Therapeutic Area: Infections and Infectious Diseases Brand Name: Bimervax
Study Phase: ApprovedProduct Type: Vaccine
Sponsor: Laboratorios HIPRA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 04, 2023
Lead Product(s) : Recombinant, Adjuvanted Covid-19 Vaccine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Laboratorios HIPRA
Deal Size : Undisclosed
Deal Type : Agreement
Details : The agreement aims for the commercialisation of HIPRA's mRNA COVID-19 vaccine, Bimervax, which combines a part of the SARS-CoV-2 virus spike protein with an adjuvant, in the United Kingdom.
Brand Name : Bimervax
Molecule Type : Vaccine
Upfront Cash : Undisclosed
August 04, 2023
Details:
Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. It is indicated for the treatment of relapsing forms of multiple sclerosis.
Lead Product(s): Teriflunomide
Therapeutic Area: Neurology Brand Name: Aubagio-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 13, 2023
Lead Product(s) : Teriflunomide
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Accord Healthcare Adds Generic Drug Approved for the Treatment of Relapsing MS
Details : Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. It is indicated for the treatment of relapsing forms of multiple sclerosis...
Brand Name : Aubagio-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 13, 2023
Details:
Lurasidone hydrochloride is a, oral atypical antipsychotic, full antagonist at dopamine D2 and serotonin 5-HT2A and 5-HT7 receptors, it is a first-line treatment option for the management of schizophrenia in adults and adolescents.
Lead Product(s): Lurasidone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Lurasidone-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2023
Lead Product(s) : Lurasidone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Accord Healthcare Offers Generic Option for Treatment of Schizophrenia and Bipolar Depression
Details : Lurasidone hydrochloride is a, oral atypical antipsychotic, full antagonist at dopamine D2 and serotonin 5-HT2A and 5-HT7 receptors, it is a first-line treatment option for the management of schizophrenia in adults and adolescents.
Brand Name : Lurasidone-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 21, 2023
Details:
Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.
Lead Product(s): Plerixafor
Therapeutic Area: Oncology Brand Name: Mozobil-Generic
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2022
Lead Product(s) : Plerixafor
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
EMA Recommends Granting a Marketing Authorisation for Plerixafor Accord
Details : Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.
Brand Name : Mozobil-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 10, 2022
Excipients
Inspections and registrations
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Intas Pharmaceuticals is a supplier offers 46 products (APIs, Excipients or Intermediates).
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