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01 1Afatinib
02 1Alectinib Hydrochloride
03 1Azacitidine
04 1Belinostat
05 1Bendamustine Hydrochloride
06 1Bicalutamide
07 1Bortezomib
08 1Buflomedil
09 1Busulfan
10 1Cabazitaxel
11 1Carboplatin
12 1Carfilzomib
13 2Cisplatin
14 1Decitabine
15 3Docetaxel
16 1Erlotinib Hydrochloride
17 3Gemcitabine
18 1Ibrutinib
19 1Irinotecan Hydrochloride
20 1Letrozole
21 1Levobupivacaine
22 1Metaxalone
23 1Oxaliplatin
24 2Paclitaxel
25 1Plerixafor
26 1Ribociclib
27 3Ropivacaine Hydrochloride
28 1Sugammadex Sodium
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01 1Active
02 9Inactive
03 26Blank
01 14Valid
02 3Withdrawn by Holder
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01 23WC-0115
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36233
Submission : 2021-10-05
Status : Inactive
Type : II
Certificate Number : R0-CEP 2021-130 - Rev 00
Issue Date : 2021-09-14
Type : Chemical
Substance Number : 2335
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-11-11
Written Confirmation Number : WC-0115
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2010-374 - Rev 09
Issue Date : 2025-09-08
Type : Chemical
Substance Number : 542
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-11-11
Written Confirmation Number : WC-0115
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2001-282 - Rev 14
Issue Date : 2024-08-26
Type : Chemical
Substance Number : 1081
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-11-11
Written Confirmation Number : WC-0115
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2025-204 - Rev 00
Issue Date : 2026-04-20
Type : Chemical
Substance Number : 599
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-11-11
Written Confirmation Number : WC-0115
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2011-189 - Rev 05
Issue Date : 2025-01-24
Type : Chemical
Substance Number : 2449
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-11-11
Written Confirmation Number : WC-0115
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2012-293 - Rev 03
Issue Date : 2024-12-02
Type : Chemical
Substance Number : 2593
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-11-11
Written Confirmation Number : WC-0115
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2012-080 - Rev 01
Issue Date : 2019-10-08
Type : Chemical
Substance Number : 2306
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-11-11
Written Confirmation Number : WC-0115
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2017-234 - Rev 03
Issue Date : 2024-04-22
Type : Chemical
Substance Number : 2675
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-11-11
Written Confirmation Number : WC-0115
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2007-193 - Rev 06
Issue Date : 2024-06-04
Type : Chemical
Substance Number : 2017
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-11-11
Written Confirmation Number : WC-0115
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2008-181 - Rev 12
Issue Date : 2025-09-29
Type : Chemical
Substance Number : 1794
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-11-11
Written Confirmation Number : WC-0115
Address of the Firm :

Fresenius Kabi Oncology Limited is a supplier offers 33 products (APIs, Excipients or Intermediates).
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