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21 Jan 2025
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19 Nov 2024
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03 Oct 2024
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GDUFA
DMF Review : Complete
Rev. Date : 2021-06-28
Pay. Date : 2021-03-11
DMF Number : 35698
Submission : 2021-04-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-17
Pay. Date : 2014-04-09
DMF Number : 26984
Submission : 2013-03-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-26
Pay. Date : 2017-05-31
DMF Number : 31569
Submission : 2017-05-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-07
Pay. Date : 2014-12-23
DMF Number : 28723
Submission : 2014-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-04
Pay. Date : 2019-07-11
DMF Number : 34008
Submission : 2019-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-19
Pay. Date : 2020-12-10
DMF Number : 35401
Submission : 2020-12-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21750
Submission : 2008-06-27
Status : Active
Type : II
CEP/COS
Certificate Numbers : R1-CEP 2002-228 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2015-04-24
Type : Chemical
Substance Number : 1972
CEP/COS
Certificate Numbers : R1-CEP 2012-073 - Rev 01
Status : Valid
Issue Date : 2020-01-13
Type : Chemical
Substance Number : 1409
CEP/COS
Certificate Numbers : R1-CEP 2007-180 - Rev 01
Status : Valid
Issue Date : 2015-04-24
Type : Chemical
Substance Number : 2223
CEP/COS
Certificate Numbers : R1-CEP 2004-300 - Rev 04
Status : Valid
Issue Date : 2017-01-18
Type : Chemical
Substance Number : 1108
CEP/COS
Certificate Numbers : CEP 2022-088 - Rev 00
Status : Valid
Issue Date : 2024-05-15
Type : Chemical
Substance Number : 1332
CEP/COS
Certificate Numbers : R0-CEP 2020-089 - Rev 00
Status : Valid
Issue Date : 2021-06-08
Type : Chemical
Substance Number : 285
CEP/COS
Certificate Numbers : R0-CEP 2021-415 - Rev 00
Status : Valid
Issue Date : 2023-07-20
Type : Chemical
Substance Number : 49
Certificate Numbers : CEP 2007-342 - Rev 04
Status : Valid
Issue Date : 2025-03-11
Type : Chemical
Substance Number : 2335
CEP/COS
Certificate Numbers : R1-CEP 2002-222 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2011-05-19
Type : Chemical
Substance Number : 1568
CEP/COS
Certificate Numbers : CEP 1998-057 - Rev 06
Status : Valid
Issue Date : 2025-04-02
Type : Chemical
Substance Number : 1156
JDMF
Registration Number : 221MF10193
Registrant's Address : Via G. B. Grassi 15-20157 Milano Italy
Initial Date of Registration : 2009-08-31
Latest Date of Registration : 2009-08-31
Registration Number : 217MF10582
Registrant's Address : Strada Statale dei Giovi, 131-20037 Paderno Dugnano (MI) - Italy
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2021-02-19
Registration Number : 218MF10948
Registrant's Address : Strada Statale dei Giovi, 131-20037 Paderno Dugnano (MI) - Italy
Initial Date of Registration : 2006-11-24
Latest Date of Registration : 2010-04-14
JDMF
Registration Number : 222MF10141
Registrant's Address : Via G. B. Grassi 15-20157 Milano Italy
Initial Date of Registration : 2010-04-20
Latest Date of Registration : 2010-04-20
JDMF
Registration Number : 218MF10871
Registrant's Address : Strada Statale dei Giovi, 131-20037 Paderno Dugnano (MI) - Italy
Initial Date of Registration : 2006-11-06
Latest Date of Registration : 2006-11-06
Registrant Name : Samchundang Pharmaceutical Co., Ltd.
Registration Date : 2011-10-21
Registration Number : 20080507-87-D-44-04(2)
Manufacturer Name : EDMOND PHARMA Srl
Manufacturer Address : Via dei Giovi 131 20037 Paderno Dugnano (MI), Italy
Registrant Name : Hanlim Pharmaceutical Co., Ltd.
Registration Date : 2008-05-07
Registration Number : 20080507-87-D-44-04
Manufacturer Name : EDMOND PHARMA SrI
Manufacturer Address : Via dei Giovi 131 20037 Paderno Dugnano (MI)
Registrant Name : Daewoong Pharmaceutical Co., Ltd.
Registration Date : 2011-01-31
Registration Number : 20110131-138-H-49-05
Manufacturer Name : EDMOND PHARMA Srl
Manufacturer Address : Strada Statale dei Giovi 131, 20037 Paderno Dugnano (MI), ITALY
NDC Package Code : 66583-0810
Start Marketing Date : 2021-04-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66583-0515
Start Marketing Date : 2016-06-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66583-0510
Start Marketing Date : 2013-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 62287-123
Start Marketing Date : 2010-04-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1.5mg/10mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 66583-0710
Start Marketing Date : 2021-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66583-0516
Start Marketing Date : 2010-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66583-0509
Start Marketing Date : 2005-09-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66583-0520
Start Marketing Date : 2016-06-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 62287-923
Start Marketing Date : 2001-05-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SOLUTION (40mg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 66583-0610
Start Marketing Date : 1998-05-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Details:
The acquisition of Recipharm, to provide innovative drug developers in the Biologics market with differentiated contract development and manufacturing services for ATMPs and builds on the capabilities acquired through GenIbet transaction and acquisition of Vibalogics.
Lead Product(s): Undisclosed
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Probiotic
Sponsor: Recipharm AB
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition February 18, 2022
Lead Product(s) : Undisclosed
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Recipharm AB
Deal Size : Undisclosed
Deal Type : Acquisition
Details : The acquisition of Recipharm, to provide innovative drug developers in the Biologics market with differentiated contract development and manufacturing services for ATMPs and builds on the capabilities acquired through GenIbet transaction and acquisition ...
Product Name : Undisclosed
Product Type : Probiotic
Upfront Cash : Undisclosed
February 18, 2022
Details:
Recipharm has reserved capacity to support the anticipated demand for the mRNA-1273 vaccine and is already in the process of recruiting additional staff and making certain investments to enable technology transfer and scale-up to commence imminently.
Lead Product(s): TAK-919
Therapeutic Area: Infections and Infectious Diseases Brand Name: mRNA-1273
Study Phase: Phase IIIProduct Type: Vaccine
Sponsor: Moderna Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 24, 2020
Lead Product(s) : TAK-919
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Moderna Therapeutics
Deal Size : Undisclosed
Deal Type : Agreement
Details : Recipharm has reserved capacity to support the anticipated demand for the mRNA-1273 vaccine and is already in the process of recruiting additional staff and making certain investments to enable technology transfer and scale-up to commence imminently.
Product Name : mRNA-1273
Product Type : Vaccine
Upfront Cash : Undisclosed
November 24, 2020
Details:
The study indicates that patients taking Erdosteine after hospital discharge benefit significant improvements in health-related quality of life parameters (HRQoL) and dyspnoea. This study is one of the first to report HRQoL details in patients with COVID-19.
Lead Product(s): Erdosteine
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 14, 2020
Lead Product(s) : Erdosteine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Recipharm’s Proprietary Molecule Erdosteine has been Positively Tested As Part of COVID-19 Treat...
Details : The study indicates that patients taking Erdosteine after hospital discharge benefit significant improvements in health-related quality of life parameters (HRQoL) and dyspnoea. This study is one of the first to report HRQoL details in patients with COVID...
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 14, 2020
Details:
Arcturus has secured manufacturing slots with Recipharm to support the manufacture of ARCT-021, Arcturus’ COVID-19 vaccine candidate that is in an ongoing phase 1/2 clinical trial.
Lead Product(s): ARCT-154
Therapeutic Area: Infections and Infectious Diseases Brand Name: LUNAR-COV19
Study Phase: Phase I/ Phase IIProduct Type: Vaccine
Sponsor: Arcturus Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 10, 2020
Lead Product(s) : ARCT-154
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Arcturus Therapeutics
Deal Size : Undisclosed
Deal Type : Agreement
Recipharm Signs Agreement with Arcturus Therapeutics to Support the Manufacture of LUNAR[®]-COV19...
Details : Arcturus has secured manufacturing slots with Recipharm to support the manufacture of ARCT-021, Arcturus’ COVID-19 vaccine candidate that is in an ongoing phase 1/2 clinical trial.
Product Name : LUNAR-COV19
Product Type : Vaccine
Upfront Cash : Undisclosed
June 10, 2020
Details:
Under the contract, Vibalogics will produce multiple batches of the vaccine candidate at its facility in Cuxhaven, Germany, expected to yield thousands of vaccine doses.
Lead Product(s): COVID-19 Vaccine
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Vaccine
Sponsor: Johnson & Johnson
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 19, 2020
Lead Product(s) : COVID-19 Vaccine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Johnson & Johnson
Deal Size : Undisclosed
Deal Type : Collaboration
Details : Under the contract, Vibalogics will produce multiple batches of the vaccine candidate at its facility in Cuxhaven, Germany, expected to yield thousands of vaccine doses.
Product Name : Undisclosed
Product Type : Vaccine
Upfront Cash : Undisclosed
May 19, 2020
Details:
The new agreement provides both companies with a long-term partnership that will ensure continued supply for patients across the globe. Opicapone (Ongentys) is approved in Europe, USA, South Korea, Taiwan, Australia and Japan.
Lead Product(s): Opicapone
Therapeutic Area: Neurology Brand Name: Ongentys
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Bial
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 10, 2020
Lead Product(s) : Opicapone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Bial
Deal Size : Undisclosed
Deal Type : Agreement
BIAL and Recipharm Expand Long-Term Supply Agreement for Opicapone API
Details : The new agreement provides both companies with a long-term partnership that will ensure continued supply for patients across the globe. Opicapone (Ongentys) is approved in Europe, USA, South Korea, Taiwan, Australia and Japan.
Product Name : Ongentys
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
January 10, 2020
Regulatory Info :
Registration Country : Norway
Dosage Form : Depot tablet
Brand Name : Isomex
Dosage Strength : 30 mg
Packaging : Blisterpakning 98item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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ABOUT THIS PAGE
Recipharm AB is a supplier offers 25 products (APIs, Excipients or Intermediates).
Find a price of Isoproterenol Hydrochloride bulk with DMF, CEP offered by Recipharm AB
Find a price of Norepinephrine Bitartrate bulk with DMF, CEP offered by Recipharm AB
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