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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 : 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 : 2016-07-19
Pay. Date : 2016-05-25
DMF Number : 30562
Submission : 2016-06-08
Status : Active
Type : II
Certificate Number : CEP 2020-178 - Rev 01
Issue Date : 2024-11-15
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 : 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 : Reviewed
Rev. Date : 2019-04-12
Pay. Date : 2019-02-14
DMF Number : 33574
Submission : 2019-03-04
Status : Active
Type : II
Certificate Number : R0-CEP 2019-143 - Rev 01
Issue Date : 2022-06-27
Type : Chemical
Substance Number : 2762
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-12
Pay. Date : 2019-03-22
DMF Number : 33730
Submission : 2019-03-26
Status : Active
Type : II
Certificate Number : CEP 2019-272 - Rev 02
Issue Date : 2024-10-14
Type : Chemical
Substance Number : 1187
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
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 : CEP 2020-090 - Rev 02
Issue Date : 2025-03-14
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 : R1-CEP 2009-089 - Rev 02
Issue Date : 2022-07-13
Type : Chemical
Substance Number : 2306
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 : R1-CEP 2012-385 - Rev 01
Issue Date : 2022-07-19
Type : Chemical
Substance Number : 1794
Status : Valid
About the Company : Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas is committed to challenging the unmet medical and societal ne...
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: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 19, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Imuldosa
Product Type : Antibody
Upfront Cash : Inapplicable
October 19, 2024
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: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 19, 2023
Lead Product(s) : Dimethyl Fumarate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Tecfidera-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 19, 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): COVID-19 Vaccine Recombinant, Adjuvanted
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Vaccine
Sponsor: Laboratorios HIPRA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 08, 2023
Lead Product(s) : COVID-19 Vaccine Recombinant, Adjuvanted
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
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.
Product Name : Undisclosed
Product Type : Vaccine
Upfront Cash : Undisclosed
April 08, 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: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 13, 2023
Lead Product(s) : Teriflunomide
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Aubagio-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 21, 2023
Lead Product(s) : Lurasidone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Lurasidone-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 11, 2022
Lead Product(s) : Plerixafor
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Mozobil-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 11, 2022
Details:
Carmustine is an anti-cancer ("antineoplastic") chemotherapy drug classified as an alkylating agent. It works by helping to halt the growth of cancer cells (cancer cell division).
Lead Product(s): Carmustine
Therapeutic Area: Oncology Brand Name: Carmustine-Generic
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 23, 2022
Lead Product(s) : Carmustine
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Accord Healthcare Launches Generic Drug for Treating Brain Tumors & Blood Cancers
Details : Carmustine is an anti-cancer ("antineoplastic") chemotherapy drug classified as an alkylating agent. It works by helping to halt the growth of cancer cells (cancer cell division).
Product Name : Carmustine-Generic
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
August 23, 2022
Details:
Through this partnership with Foresee on the launch of CAMCEVI, Accord BioPharma with razor sharp focus on specialty pharmaceuticals, which will go beyond biology to bring more access to high-quality medicines to patients across the U.S.
Lead Product(s): Leuprolide Mesylate
Therapeutic Area: Oncology Brand Name: Camcevi
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Foresee Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership April 04, 2022
Lead Product(s) : Leuprolide Mesylate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Foresee Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Partnership
Accord BioPharma, in Partnership with Foresee Pharmaceuticals, Launches CAMCEVI™ (Leuprolide) In...
Details : Through this partnership with Foresee on the launch of CAMCEVI, Accord BioPharma with razor sharp focus on specialty pharmaceuticals, which will go beyond biology to bring more access to high-quality medicines to patients across the U.S.
Product Name : Camcevi
Product Type : Hormone
Upfront Cash : Undisclosed
April 04, 2022
Details:
CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24.
Lead Product(s): Leuprolide Mesylate
Therapeutic Area: Oncology Brand Name: Camcevi
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 31, 2022
Lead Product(s) : Leuprolide Mesylate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Accord BioPharma Announces U.S. Launch for CAMCEVI™ (Leuprolide) Injection Emulsion for the Trea...
Details : CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on D...
Product Name : Camcevi
Product Type : Hormone
Upfront Cash : Inapplicable
March 31, 2022
Details:
Sondelbay (teriparatide), is a self-administered, once-a-day subcutaneous injection for patients with osteoporosis using a pen device, is indicated for treatment of osteoporosis.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Brand Name: Sondelbay
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 28, 2022
Lead Product(s) : Teriparatide
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Accord's SONDELBAY® (teriparatide) is Given Green Light by CHMP
Details : Sondelbay (teriparatide), is a self-administered, once-a-day subcutaneous injection for patients with osteoporosis using a pen device, is indicated for treatment of osteoporosis.
Product Name : Sondelbay
Product Type : Peptide
Upfront Cash : Inapplicable
January 28, 2022
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Intas Pharmaceuticals is a supplier offers 48 products (APIs, Excipients or Intermediates).
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