01 1Afatinib
02 1Alectinib Hydrochloride
03 1Anastrozole
04 1Belinostat
05 1Bendamustine Hydrochloride
06 1Bicalutamide
07 1Bortezomib
08 1Buflomedil
09 1Busulfan
10 1Cabazitaxel
11 1Carboplatin
12 1Carfilzomib
13 1Cisplatin
14 1Decitabine
15 2Docetaxel
16 1Erlotinib Hydrochloride
17 1Gefitinib
18 3Gemcitabine
19 1Ibrutinib
20 1Imatinib Mesylate
21 1Irinotecan Hydrochloride
22 1Letrozole
23 1Levobupivacaine
24 1Metaxalone
25 1Oxaliplatin
26 1Paclitaxel
27 1Pemetrexed Disodium
28 1Plerixafor
29 1Ribociclib
30 2Ropivacaine Hydrochloride
31 1Sugammadex Sodium
01 10Inactive
02 25Blank
01 13Valid
02 3Withdrawn by Holder
03 19Blank
01 35Blank
01 19WC-0115
02 6WC-0115A3
03 10Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30927
Submission : 2016-12-31
Status : Inactive
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-15
Written Confirmation Number : WC-0115A3
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33869
Submission : 2019-06-12
Status : Inactive
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-15
Written Confirmation Number : WC-0115A3
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2012-369 - Rev 00
Issue Date : 2021-05-20
Type : Chemical
Substance Number : 2196
Status : Valid
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
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 07
Issue Date : 2023-10-13
Type : Chemical
Substance Number : 542
Status : Valid
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
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 : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0115
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29750
Submission : 2016-01-30
Status : Inactive
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-15
Written Confirmation Number : WC-0115A3
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2011-189 - Rev 04
Issue Date : 2023-02-16
Type : Chemical
Substance Number : 2449
Status : Valid
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0115
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-271 - Rev 00
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 2306
Status : Valid
Date of Issue : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0115
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31199
Submission : 2017-05-12
Status : Inactive
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-15
Written Confirmation Number : WC-0115A3
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 : 2019-07-08
Valid Till : 2022-07-07
Written Confirmation Number : WC-0115
Address of the Firm :
Fresenius Kabi Oncology Limited is a supplier offers 32 products (APIs, Excipients or Intermediates).
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