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07 Nov 2025
// FDA
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-three-lots-famotidine-injection-usp-20-mg-2-ml-10

29 Sep 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250930914731/en/CMS-Grants-Fresenius-Kabi-Permanent-Product-Specific-Q-Code-for-Conexxence-and-Bomyntra-denosumab-bnht

07 Sep 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250907375462/en/Fresenius-Kabi-and-AABB-Announce-20th-Anniversary-of-Blood-Collectors-Week-September-714-2025-Honoring-Lifesaving-Blood-Collection-Professionals

13 Aug 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250805925297/en/Polpharma-Biologics-and-Fresenius-Kabi-Sign-Licensing-Agreement-for-Proposed-Vedolizumab-Biosimilar-PB016

09 Jul 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020280

02 Jul 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mabxience-announces-european-commission-approval-of-denosumab-biosimilars-302496762.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38038
Submission : 2023-04-18
Status : Active
Type : II
Certificate Number : R1-CEP 1998-025 - Rev 08
Issue Date : 2021-06-10
Type : Chemical
Substance Number : 661
Status : Valid
NDC Package Code : 66558-0211
Start Marketing Date : 2022-07-29
End Marketing Date : 2026-12-31
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 : 23287
Submission : 2009-11-20
Status : Active
Type : II
NDC Package Code : 66558-0201
Start Marketing Date : 2011-07-04
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (5.28kg/8kg 2.72kg/8kg)
Marketing Category : DRUG FOR FURTHER PRO...

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25477
Submission : 2011-11-03
Status : Active
Type : II
NDC Package Code : 66558-0080
Start Marketing Date : 2011-06-02
End Marketing Date : 2026-12-31
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 : 23699
Submission : 2010-04-07
Status : Active
Type : II
NDC Package Code : 66558-0060
Start Marketing Date : 2011-12-22
End Marketing Date : 2026-12-31
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 : 2014-05-16
Pay. Date : 2014-05-05
DMF Number : 20985
Submission : 2007-10-31
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-28
Pay. Date : 2014-04-18
DMF Number : 19627
Submission : 2006-07-21
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-03
Pay. Date : 2013-12-17
DMF Number : 25387
Submission : 2011-09-01
Status : Active
Type : II
NDC Package Code : 66558-0202
Start Marketing Date : 2011-05-11
End Marketing Date : 2026-12-31
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 : 2014-06-23
Pay. Date : 2013-12-20
DMF Number : 24941
Submission : 2011-05-11
Status : Active
Type : II
NDC Package Code : 66558-0203
Start Marketing Date : 2017-01-25
End Marketing Date : 2026-12-31
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 : 17966
Submission : 2004-12-30
Status : Active
Type : II
Registrant Name : Samyang Biopharm Co., Ltd.
Registration Date : 2024-08-13
Registration Number : 20061031-68-A-193-08(5)
Manufacturer Name : Fresenius Kabi Oncology Limited
Manufacturer Address : D-35, industrial Area, Kalyani, Nadia, West Bengal-741 235, INDIA

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25526
Submission : 2011-11-21
Status : Active
Type : II

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Fresenius Kabi AB Brunna is a supplier offers 56 products (APIs, Excipients or Intermediates).
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