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17 Dec 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/12/17/2997976/0/en/Sandoz-takes-further-steps-to-resolve-legacy-US-Generic-Drug-Antitrust-Class-Action-Litigation.html
21 Nov 2024
// ENDPTS
https://endpts.com/fda-updates-label-of-33-year-old-cancer-drug-with-new-dose-and-warning/
20 Nov 2024
// ENDPTS
https://endpts.com/fda-updates-label-of-33-year-old-cancer-drug-with-new-dose-and-warning/
18 Nov 2024
// BUSINESSWIRE
16 Nov 2024
// FINANCIALXPRESS
https://www.financialexpress.com/business/healthcare-european-commission-grants-approval-to-sandozs-biosimilar-to-treat-retinal-diseases-3666104/
15 Nov 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/11/15/2981760/0/en/Sandoz-receives-European-Commission-approval-for-Afqlir-aflibercept-further-strengthening-leading-biosimilar-portfolio.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-13
Pay. Date : 2019-08-09
DMF Number : 13764
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R2-CEP 1995-034 - Rev 06
Issue Date : 2015-11-12
Type : Chemical
Substance Number : 260
Status : Valid
Registration Number : 306MF10115
Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria
Initial Date of Registration : 2024-08-22
Latest Date of Registration :
NDC Package Code : 55984-0218
Start Marketing Date : 2022-04-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2024-08-23
Registration Number : 20240823-30-A-380-25
Manufacturer Name : Sandoz GmbH
Manufacturer Address : Biochemiestrasse 10, 6250 Kundl, Tyrol, Austria
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-23
Pay. Date : 2023-05-22
DMF Number : 38086
Submission : 2023-06-02
Status : Active
Type : II
Certificate Number : CEP 2023-277 - Rev 00
Issue Date : 2023-09-18
Type : Chemical
Substance Number : 260
Status : Valid
Registration Number : 217MF10761
Registrant's Address : Ctra. Granollers-Cardedeu C-251, Km 4, E-08520, Les Franqueses del Valles (Barcelona), Spain
Initial Date of Registration : 2005-10-20
Latest Date of Registration :
NDC Package Code : 55984-0218
Start Marketing Date : 2022-04-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2024-08-23
Registration Number : 20240823-30-A-380-25
Manufacturer Name : Sandoz GmbH
Manufacturer Address : Biochemiestrasse 10, 6250 Kundl, Tyrol, Austria
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-20
Pay. Date : 2023-04-17
DMF Number : 13754
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 1993-005 - Rev 08
Issue Date : 2024-02-20
Type : Chemical
Substance Number : 578
Status : Valid
Registration Number : 217MF10454
Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria
Initial Date of Registration : 2005-08-24
Latest Date of Registration :
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2021-11-05
Registration Number : 20200603-210-J-404(1)
Manufacturer Name : Sandoz GmbH@Sandoz Industrial Products S.A.
Manufacturer Address : Biochemiestraβe 10 6250 Kundl Austria@Ctra. Granollers - Cardedeu C-251, km 4 08520 LES FRANQUESES DEL VALLES BARCELONA Spain
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13704
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2005-121 - Rev 02
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 331
Status : Valid
Registration Number : 220MF10041
Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia
Initial Date of Registration : 2008-02-05
Latest Date of Registration :
NDC Package Code : 48866-8256
Start Marketing Date : 2013-07-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT FOR ...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-15
Pay. Date : 2012-12-21
DMF Number : 4789
Submission : 1983-01-06
Status : Active
Type : II
Certificate Number : CEP 1998-141 - Rev 11
Issue Date : 2023-09-26
Type : Chemical
Substance Number : 401
Status : Valid
Registration Number : 217MF10456
Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria
Initial Date of Registration : 2005-08-24
Latest Date of Registration :
NDC Package Code : 43858-410
Start Marketing Date : 2010-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
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 : 13767
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 2001-395 - Rev 03
Issue Date : 2019-11-20
Type : Chemical
Substance Number : 113
Status : Valid
Registration Number : 231MF10072
Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria
Initial Date of Registration : 2019-03-12
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 : 16542
Submission : 2003-04-15
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-283 - Rev 01
Issue Date : 2017-12-05
Type : Chemical
Substance Number : 2341
Status : Valid
Registration Number : 225MF10129
Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria
Initial Date of Registration : 2013-07-09
Latest Date of Registration :
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2014-07-25
Registration Number : 20140611-25-A-300-07(1)
Manufacturer Name : Sandoz GmbH
Manufacturer Address : Biochemiestraβe 10, 6250 Kundl, Austria
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16847
Submission : 2003-09-18
Status : Inactive
Type : II
Certificate Number : CEP 1999-017 - Rev 05
Issue Date : 2023-09-22
Type : Chemical
Substance Number : 115
Status : Valid
Registration Number : 229MF10169
Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria
Initial Date of Registration : 2017-08-28
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 : 20765
Submission : 2007-08-09
Status : Active
Type : II
Certificate Number : R0-CEP 2016-321 - Rev 01
Issue Date : 2019-04-15
Type : Chemical
Substance Number : 2631
Status : Withdrawn by Holder
Registration Number : 228MF10155
Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia
Initial Date of Registration : 2016-08-08
Latest Date of Registration :
Registrant Name : Korea Sandoz Co., Ltd.
Registration Date : 2021-04-06
Registration Number : 20210406-209-J-687
Manufacturer Name : Lek Pharmaceuticals dd
Manufacturer Address : Kolodvorska cesta 27,1234 Menges, Slovenia
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13223
Submission : 1998-04-30
Status : Inactive
Type : II
Certificate Number : R1-CEP 2004-179 - Rev 03
Issue Date : 2019-12-18
Type : Chemical
Substance Number : 1058
Status : Valid
Registration Number : 217MF10740
Registrant's Address : Verovskova 57, SI-1526 Ljubljana, Slovenia
Initial Date of Registration : 2005-10-07
Latest Date of Registration :
Regulatory Info :
Registration Country : Italy
Dosage Form : Idarubicin 10Mg 10Ml 1 Units P...
Dosage Strength : 1 vial EV 10 ml 1 mg/ml
Packaging :
Brand Name : Idarubicin
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Idarubicin 5Mg 5Ml 1 Units Par...
Dosage Strength : 1 vial EV 5 ml 1 mg/ml
Packaging :
Brand Name : Idarubicin
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Filmtabl
Dosage Strength : 600/300mg
Packaging :
Brand Name : Abacavir Lamivudin Sandoz
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Filmtabl
Dosage Strength : 500mg
Packaging :
Brand Name : Abirateron Sandoz
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Filmtabl
Dosage Strength : 1000mg
Packaging :
Brand Name : Abirateron Sandoz
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Gran
Dosage Strength : 100mg
Packaging :
Brand Name : Ecomucyl Sandoz
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Gran
Dosage Strength : 200mg
Packaging :
Brand Name : Ecomucyl Sandoz
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Gran
Dosage Strength : 200mg
Packaging :
Brand Name : Ecomucyl Sandoz
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Effervescent Tablets
Dosage Strength : 200mg
Packaging :
Brand Name : Ecomucyl Sandoz
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Effervescent Tablets
Dosage Strength : 600mg
Packaging :
Brand Name : Ecomucyl Sandoz
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Excipients
Inspections and registrations
ABOUT THIS PAGE
Sandoz B2B is a supplier offers 141 products (APIs, Excipients or Intermediates).
Find a price of Amoxicillin Trihydrate bulk with DMF, CEP, JDMF offered by Sandoz B2B
Find a price of Ampicillin Sodium bulk with DMF, CEP, JDMF offered by Sandoz B2B
Find a price of Levothyroxine Sodium bulk with DMF, CEP, JDMF offered by Sandoz B2B
Find a price of Penicillin G Potassium bulk with DMF, CEP, JDMF offered by Sandoz B2B
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Find a price of Ampicillin bulk with DMF, CEP offered by Sandoz B2B
Find a price of Ampicillin Trihydrate bulk with DMF, CEP offered by Sandoz B2B
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Find a price of Penicillin G Benzathine bulk with DMF, CEP offered by Sandoz B2B
Find a price of Penicillin G Procaine bulk with DMF, CEP offered by Sandoz B2B
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Find a price of CAS 24280-93-1 bulk with DMF offered by Sandoz B2B
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Find a price of RS-86 CAPSULES IN 0.25 mg AND 1.0 mg (BASLE, SWITZERLAND PLANT) bulk offered by Sandoz B2B
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