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03 Sep 2022
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-15
Pay. Date : 2012-11-19
DMF Number : 26030
Submission : 2012-05-08
Status : Active
Type : II
Certificate Number : CEP 2012-235 - Rev 02
Issue Date : 2024-10-28
Type : Chemical
Substance Number : 1058
Status : Valid
Registration Number : 304MF10074
Registrant's Address : No. 8 Nangang Road, Jiangyin Industrial Concentration Zone, Fuqing, Fuzhou City, Fujian Province, P. R. China 350309
Initial Date of Registration : 2022-05-18
Latest Date of Registration :
NDC Package Code : 42513-0005
Start Marketing Date : 2013-06-11
End Marketing Date : 2025-12-31
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 : 2021-06-07
Pay. Date : 2021-03-17
DMF Number : 35188
Submission : 2020-10-30
Status : Active
Type : II
Certificate Number : R0-CEP 2021-063 - Rev 01
Issue Date : 2022-04-01
Type : Chemical
Substance Number : 2089
Status : Valid
NDC Package Code : 42513-0016
Start Marketing Date : 2021-01-28
End Marketing Date : 2025-12-31
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 : 2019-09-12
Pay. Date : 2019-05-16
DMF Number : 28350
Submission : 2014-05-30
Status : Active
Type : II
Certificate Number : R0-CEP 2018-085 - Rev 04
Issue Date : 2022-12-06
Type : Chemical
Substance Number : 319
Status : Valid
NDC Package Code : 42513-0007
Start Marketing Date : 2013-11-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-210-J-908
Manufacturer Name : Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Manufacturer Address : No. 8 Nangang Road, Jiangyin Industrial Concentration Zone, Fuqing, Fuzhou City, Fujian Province, PR China.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29420
Submission : 2015-05-19
Status : Active
Type : II
Certificate Number : R1-CEP 2017-134 - Rev 00
Issue Date : 2023-01-26
Type : Chemical
Substance Number : 1656
Status : Valid
NDC Package Code : 20076-1245
Start Marketing Date : 2015-01-05
End Marketing Date : 2025-12-31
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 : 35909
Submission : 2021-05-30
Status : Active
Type : II
Certificate Number : CEP 2021-423 - Rev 01
Issue Date : 2024-04-22
Type : Chemical
Substance Number : 1656
Status : Valid
NDC Package Code : 42513-0018
Start Marketing Date : 2021-12-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6097
Submission : 2015-01-22
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 : 38019
Submission : 2023-09-28
Status : Active
Type : II
Certificate Number : CEP 2023-251 - Rev 00
Issue Date : 2024-03-19
Type : Chemical
Substance Number : 203
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-24
Pay. Date : 2020-09-29
DMF Number : 35042
Submission : 2020-08-31
Status : Active
Type : II
Certificate Number : CEP 2024-023 - Rev 00
Issue Date : 2024-06-25
Type : Chemical
Substance Number : 645
Status : Valid
NDC Package Code : 42513-0011
Start Marketing Date : 2020-08-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2023-04-12
Registration Number : 20220512-210-J-1289(1)
Manufacturer Name : Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Manufacturer Address : No.8 Nangang Road, Jiangyin Industrial Concentration Zone, Fuqing, Fuzhou City, Fujian Province, PR China, 350309
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-06
Pay. Date : 2013-07-31
DMF Number : 26310
Submission : 2012-08-08
Status : Active
Type : II
Certificate Number : CEP 2020-058 - Rev 03
Issue Date : 2024-10-28
Type : Chemical
Substance Number : 1058
Status : Valid
NDC Package Code : 42513-0005
Start Marketing Date : 2013-06-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32322
Submission : 2017-11-23
Status : Inactive
Type : II
Certificate Number : R0-CEP 2018-090 - Rev 02
Issue Date : 2021-12-09
Type : Chemical
Substance Number : 583
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18539
Submission : 2005-07-20
Status : Active
Type : II
NDC Package Code : 20076-0402
Start Marketing Date : 2015-05-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
CEP/COS
Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Certificate Numbers : R0-CEP 2021-063 - Rev 01
Status : Valid
Issue Date : 2022-04-01
Type : Chemical
Substance Number : 2089
CEP/COS
Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Certificate Numbers : R0-CEP 2018-085 - Rev 04
Status : Valid
Issue Date : 2022-12-06
Type : Chemical
Substance Number : 319
CEP/COS
Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Certificate Numbers : R1-CEP 2011-372 - Rev 03
Status : Valid
Issue Date : 2022-11-03
Type : Chemical
Substance Number : 320
CEP/COS
Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Certificate Numbers : R0-CEP 2015-094 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2015-07-07
Type : Chemical
Substance Number : 320
CEP/COS
Certificate Numbers : R0-CEP 2018-090 - Rev 02
Status : Valid
Issue Date : 2021-12-09
Type : Chemical
Substance Number : 583
Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Certificate Numbers : CEP 2018-024 - Rev 04
Status : Valid
Issue Date : 2023-10-11
Type : Chemical
Substance Number : 2536
Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Certificate Numbers : R0-CEP 2020-124 - Rev 02
Status : Valid
Issue Date : 2022-05-12
Type : Chemical
Substance Number : 2536
Livzon New North River Pharmaceutical
Certificate Numbers : R1-CEP 2017-134 - Rev 00
Status : Valid
Issue Date : 2023-01-26
Type : Chemical
Substance Number : 1656
Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Certificate Numbers : CEP 2021-423 - Rev 01
Status : Valid
Issue Date : 2024-04-22
Type : Chemical
Substance Number : 1656
CEP/COS
Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Certificate Numbers : CEP 2023-251 - Rev 00
Status : Valid
Issue Date : 2024-03-19
Type : Chemical
Substance Number : 203
Details:
Zastaprazan is a P-CAB (potassium-competitive acid-blocking) candidate, a class of drugs that is replacing existing PPIs (proton pump inhibitors) for peptic ulcer disease, including GERD. Livzon will have rights to JP 1366 (zastaprazan) in China, Taiwan, Hong Kong and Macau.
Lead Product(s): Zastaprazan
Therapeutic Area: Gastroenterology Brand Name: JP 1366
Study Phase: Phase IIIProduct Type: Small molecule
Recipient: Onconic Therapeutics
Deal Size: $127.5 million Upfront Cash: $15.0 million
Deal Type: Acquisition March 14, 2023
Lead Product(s) : Zastaprazan
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Recipient : Onconic Therapeutics
Deal Size : $127.5 million
Deal Type : Acquisition
Livzon Acquires Rights to GERD Therapy from Onconic for $127.5 Million
Details : Zastaprazan is a P-CAB (potassium-competitive acid-blocking) candidate, a class of drugs that is replacing existing PPIs (proton pump inhibitors) for peptic ulcer disease, including GERD. Livzon will have rights to JP 1366 (zastaprazan) in China, Taiwan,...
Brand Name : JP 1366
Molecule Type : Small molecule
Upfront Cash : $15.0 million
March 14, 2023
Details:
Under the terms of the license agreement, Bright Peak will receive the right to develop, manufacture and commercialize PD-1 ICs, including LZM009 on a worldwide basis while Livzon retains certain rights of first negotiation to obtain exclusivity in the greater China territory.
Lead Product(s): LZM009
Therapeutic Area: Oncology Brand Name: LZM009
Study Phase: Phase IProduct Type: Large molecule
Sponsor: Bright Peak Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 16, 2021
Lead Product(s) : LZM009
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Bright Peak Therapeutics
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Bright Peak Therapeutics Licenses Rights to Livzon’s Anti-PD-1 Antibody LZM009 to Develop Novel ...
Details : Under the terms of the license agreement, Bright Peak will receive the right to develop, manufacture and commercialize PD-1 ICs, including LZM009 on a worldwide basis while Livzon retains certain rights of first negotiation to obtain exclusivity in the g...
Brand Name : LZM009
Molecule Type : Large molecule
Upfront Cash : Undisclosed
November 16, 2021
Details:
LTS grants to LIVZON and its Affiliates an exclusive royalty-bearing, sublicensable right and license to jointly develop with LTS the Asenapine TTS and commercialize the Asenapine TTS for the treatment of schizophrenia in China (including Hong Kong and Macau).
Lead Product(s): Asenapine Maleate
Therapeutic Area: Psychiatry/Psychology Brand Name: Asenapine TTS
Study Phase: PreclinicalProduct Type: Small molecule
Recipient: LTS - Lohmann Therapie Systeme
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 06, 2020
Lead Product(s) : Asenapine Maleate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Preclinical
Recipient : LTS - Lohmann Therapie Systeme
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : LTS grants to LIVZON and its Affiliates an exclusive royalty-bearing, sublicensable right and license to jointly develop with LTS the Asenapine TTS and commercialize the Asenapine TTS for the treatment of schizophrenia in China (including Hong Kong and M...
Brand Name : Asenapine TTS
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 06, 2020
Inspections and registrations
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Livzon Pharmaceutical Group is a supplier offers 4 products (APIs, Excipients or Intermediates).
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