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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
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21 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-presents-new-results-of-radicava-ors-edaravone-from-a-phase-3b-efficacy-and-safety-extension-study-and-a-clinical-analysis-of-multiple-studies-at-neals-2024-302280605.html
17 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-unveils-new-als-research-findings-at-neals-2024-annual-meeting-302278438.html
15 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-to-showcase-als-research-at-2024-aanem-annual-meeting-302275445.html
10 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-to-showcase-new-radicava-ors-edaravone-real-world-data-at-2024-academy-of-managed-care-pharmacy-nexus-meeting-302272093.html
06 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-to-present-radicava-ors-edaravone-data-at-the-2024-national-association-of-specialty-pharmacy-annual-meeting-302267885.html
30 Sep 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-presents-open-label-extension-outcomes-and-additional-data-from-phase-3-boundless-trial-of-investigational-nd0612-in-parkinsons-disease-302261504.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 228MF10013
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 3-2-10
Initial Date of Registration : 2016-01-08
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 222MF10221
Registrant's Address : 3-16-89 Kashima, Yodogawa-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2010-08-23
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3059
Submission : 1977-11-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-177 - Rev 05
Issue Date : 2015-10-19
Type : Chemical
Substance Number : 1004
Status : Withdrawn by Holder
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2022-10-20
Registration Number : 20221020-209-J-1386
Manufacturer Name : Mitsubishi Tanabe Pharma Factory Ltd.
Manufacturer Address : 7473-2, Ooaza Onoda, Sanyoonoda, Yamaguchi 756-0054, Japan
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 229MF10027
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 3-2-10
Initial Date of Registration : 2017-02-08
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2013-209 - Rev 00
Issue Date : 2021-09-28
Type : Chemical
Substance Number : 1961
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3312
Submission : 1978-08-09
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2022-281 - Rev 02
Issue Date : 2024-06-26
Type : Chemical
Substance Number : 1961
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10061
Submission : 1993-01-26
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 : 10062
Submission : 1993-01-26
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 : 10063
Submission : 1993-01-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13191
Submission : 1998-09-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1990
Submission : 1972-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4259
Submission : 1981-07-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4194
Submission : 1981-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4202
Submission : 1981-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7593
Submission : 1988-07-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3059
Submission : 1977-11-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10381
Submission : 1993-07-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11077
Submission : 1994-09-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1832
Submission : 1971-12-17
Status : Inactive
Type : II
JDMF
Registration Number : 222MF10221
Registrant's Address : 3-16-89 Kashima, Yodogawa-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2010-08-23
Latest Date of Registration : 2017-02-08
JDMF
Registration Number : 228MF10013
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 3-2-10
Initial Date of Registration : 2016-01-08
Latest Date of Registration : 2016-01-08
JDMF
Registration Number : 229MF10027
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 3-2-10
Initial Date of Registration : 2017-02-08
Latest Date of Registration : 2017-12-25
Details:
ND0612 is a continuous, subcutaneous infusion levodopa/carbidopa delivery system under development for patients with Parkinson's disease (PD) and motor fluctuations.
Lead Product(s): Etilevodopa,Carbidopa
Therapeutic Area: Neurology Brand Name: ND0612
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2024
Lead Product(s) : Etilevodopa,Carbidopa
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Mitsubishi Tanabe Presents Data from Phase 3 BouNDless Trial of ND0612 in Parkinson's
Details : ND0612 is a continuous, subcutaneous infusion levodopa/carbidopa delivery system under development for patients with Parkinson's disease (PD) and motor fluctuations.
Brand Name : ND0612
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 30, 2024
Details:
Moderna and Mitsubishi entered into a joint agreement regarding the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Japan, including Moderna's COVID-19 vaccine, Spikevax.
Lead Product(s): Covid-19 Vaccine
Therapeutic Area: Infections and Infectious Diseases Brand Name: Spikevax
Study Phase: ApprovedProduct Type: Vaccine
Recipient: Moderna Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 08, 2024
Lead Product(s) : Covid-19 Vaccine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Recipient : Moderna Therapeutics
Deal Size : Undisclosed
Deal Type : Agreement
Moderna and Mitsubishi Tanabe Sign Agreement for mRNA Vaccines in Japan
Details : Moderna and Mitsubishi entered into a joint agreement regarding the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Japan, including Moderna's COVID-19 vaccine, Spikevax.
Brand Name : Spikevax
Molecule Type : Vaccine
Upfront Cash : Undisclosed
July 08, 2024
Details:
Ethypharm acquired Mitsubishi Tanabe's selective antithrombin agent Arganova (argatroban monohydrate) in Europe. It is indicated for the treatment of heparin-induced thrombocytopenia type II.
Lead Product(s): Argatroban Monohydrate
Therapeutic Area: Hematology Brand Name: Arganova
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Ethypharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 17, 2024
Lead Product(s) : Argatroban Monohydrate
Therapeutic Area : Hematology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Ethypharm
Deal Size : Undisclosed
Deal Type : Acquisition
Acquisition of Argatroban Business in Europe
Details : Ethypharm acquired Mitsubishi Tanabe's selective antithrombin agent Arganova (argatroban monohydrate) in Europe. It is indicated for the treatment of heparin-induced thrombocytopenia type II.
Brand Name : Arganova
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 17, 2024
Details:
The net proceeds will be used for the lead optimization of a novel and very promising T. cruzi active series being developed for the treatment of Chagas disease.
Lead Product(s): Undisclosed
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: DiscoveryProduct Type: Undisclosed
Sponsor: The Global Health Innovative Technology
Deal Size: $1.9 million Upfront Cash: Undisclosed
Deal Type: Funding May 08, 2024
Lead Product(s) : Undisclosed
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Discovery
Partner/Sponsor/Collaborator : The Global Health Innovative Technology
Deal Size : $1.9 million
Deal Type : Funding
USD 10.8 Mn Invested in New Drug Development for Malaria with Japanese Pharma Partners
Details : The net proceeds will be used for the lead optimization of a novel and very promising T. cruzi active series being developed for the treatment of Chagas disease.
Brand Name : Undisclosed
Molecule Type : Undisclosed
Upfront Cash : Undisclosed
May 08, 2024
Details:
Radicava ORS (edaravone) is a free radical scavenger available in the form of oral suspension, which is approved by USFDA for the treatment of amyotrophic lateral sclerosis.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Brand Name: Radicava ORS
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2024
Mitsubishi Tanabe Pharma America Receives Orphan Drug Exclusivity for RADICAVA ORS®
Details : Radicava ORS (edaravone) is a free radical scavenger available in the form of oral suspension, which is approved by USFDA for the treatment of amyotrophic lateral sclerosis.
Brand Name : Radicava ORS
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 08, 2024
Details:
Daiichi will transfer distribution rights for Tenelia (teneligliptin) to Mitsubishi, ending joint medical information activities for all products.
Lead Product(s): Teneligliptin Hydrobromide
Therapeutic Area: Endocrinology Brand Name: Tenelia
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Daiichi Sankyo
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination March 04, 2024
Lead Product(s) : Teneligliptin Hydrobromide
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Daiichi Sankyo
Deal Size : Undisclosed
Deal Type : Termination
Expiration of Marketing Alliance for TENELIA® and CANAGLU® Tablets
Details : Daiichi will transfer distribution rights for Tenelia (teneligliptin) to Mitsubishi, ending joint medical information activities for all products.
Brand Name : Tenelia
Molecule Type : Small molecule
Upfront Cash : Undisclosed
March 04, 2024
Details:
ND0612 is an investigative drug-device combination therapy – a 24 hours/day, continuous subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) for people with Parkinson’s disease (PD) experiencing motor fluctuations.
Lead Product(s): Etilevodopa,Carbidopa
Therapeutic Area: Neurology Brand Name: ND0612
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: NeuroDerm
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 28, 2023
Lead Product(s) : Etilevodopa,Carbidopa
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : NeuroDerm
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ND0612 is an investigative drug-device combination therapy – a 24 hours/day, continuous subcutaneous infusion of liquid levodopa/carbidopa (LD/CD) for people with Parkinson’s disease (PD) experiencing motor fluctuations.
Brand Name : ND0612
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 28, 2023
Details:
Mounjaro (tirzepatide) is a GIP receptor and GLP-1 receptor agonist, which enhances first- and second-phase insulin secretion, and reduces glucagon levels, both in a glucosedependent manner.
Lead Product(s): Tirzepatide
Therapeutic Area: Endocrinology Brand Name: Mounjaro
Study Phase: ApprovedProduct Type: Peptide
Recipient: Eli Lilly
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2023
Lead Product(s) : Tirzepatide
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Recipient : Eli Lilly
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Mounjaro (tirzepatide) is a GIP receptor and GLP-1 receptor agonist, which enhances first- and second-phase insulin secretion, and reduces glucagon levels, both in a glucosedependent manner.
Brand Name : Mounjaro
Molecule Type : Peptide
Upfront Cash : Not Applicable
April 18, 2023
Details:
Radicava ORS (edaravone) is a free radical scavenger used to delay the progression of amyotrophic lateral sclerosis (ALS) due to the therapeutic effect of its known antioxidant properties as oxidative stress kills neurons in patients with ALS.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Brand Name: Radicava ORS
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2023
Details : Radicava ORS (edaravone) is a free radical scavenger used to delay the progression of amyotrophic lateral sclerosis (ALS) due to the therapeutic effect of its known antioxidant properties as oxidative stress kills neurons in patients with ALS.
Brand Name : Radicava ORS
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 23, 2023
Details:
Radicava ORS (edaravone) is a free radical scavenger used to delay the progression of amyotrophic lateral sclerosis (ALS) due to the therapeutic effect of its known antioxidant properties as oxidative stress kills neurons in patients with ALS.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Brand Name: Radicava ORS
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2023
Details : Radicava ORS (edaravone) is a free radical scavenger used to delay the progression of amyotrophic lateral sclerosis (ALS) due to the therapeutic effect of its known antioxidant properties as oxidative stress kills neurons in patients with ALS.
Brand Name : Radicava ORS
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 27, 2023
Excipients
Dosage Form : Inhalation
Grade : Inhalation
Application : Empty Capsules
Excipient Details : Quali-V®-I is the first plant-based capsule that responds to the particular functional properties required for use in dry powder inhaler (DPI) devices.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Dosage Form : Clinical Supply, HardGel
Grade : Oral
Application : Empty Capsules
Excipient Details : Quali-G™ is first preservative-free gelatin capsule, the market standard solid dosage form designed to meet the demanding requirements of the pharmaceutical industry.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Excipients by Ingredients
Excipients By applications
Inspections and registrations
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Mitsubishi Tanabe Pharma is a supplier offers 57 products (APIs, Excipients or Intermediates).
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