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// FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/sandoz-11b-spree-slovenia-earmarks-440m-new-biosimilar-plant
02 Jul 2025
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27 Jun 2025
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https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-nationwide-recall-one-lot-cefazolin-injection-due-product-mispackaging
02 Jun 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/06/02/3091537/0/en/Sandoz-launches-first-and-only-interchangeable-denosumab-biosimilars-in-US-providing-new-affordable-treatment-options-for-over-10-million-patients-1.html
21 May 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/05/21/3085965/0/en/Sandoz-launches-Pyzchiva-autoinjector-first-commercially-available-in-Europe-for-ustekinumab-biosimilars.html
20 May 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214311
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 :
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 01
Issue Date : 2024-12-17
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 :
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2014-08-27
Registration Number : 20050831-30-A-59-01(8)
Manufacturer Name : Sandoz Industrial Products SA
Manufacturer Address : Ctra. Granollers a Cardedeu Km4 E-08520 Les Franques del Barcelona,Spain
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 2024-480 - Rev 00
Issue Date : 2025-01-20
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 : 2025-12-31
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 : CEP 1999-017 - Rev 05
Issue Date : 2023-09-22
Type : Chemical
Substance Number : 115
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 : R1-CEP 2001-395 - Rev 03
Issue Date : 2019-11-20
Type : Chemical
Substance Number : 113
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 : 13212
Submission : 1998-04-30
Status : Active
Type : II
Certificate Number : R1-CEP 1999-188 - Rev 03
Issue Date : 2018-01-15
Type : Chemical
Substance Number : 167
Status : Valid
Excipients
Inspections and registrations
ABOUT THIS PAGE
Sandoz Canada Inc. is a supplier offers 150 products (APIs, Excipients or Intermediates).
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