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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 3Docetaxel
16 1Erlotinib Hydrochloride
17 1Gefitinib
18 3Gemcitabine
19 1Ibrutinib
20 1Imatinib Mesylate
21 1Irinotecan Hydrochloride
22 1Letrozole
23 1Levobupivacaine
24 1Metaxalone
25 1Oxaliplatin
26 2Paclitaxel
27 1Pemetrexed Disodium
28 1Plerixafor
29 1Ribociclib
30 3Ropivacaine Hydrochloride
31 1Sugammadex Sodium
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01 10Inactive
02 28Blank
01 13Valid
02 3Withdrawn by Holder
03 22Blank
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01 38Blank
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01 32WC-0115
02 6Blank
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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 : 2022-09-16
Valid Till : 2025-09-15
Written Confirmation Number : WC-0115
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 : 2022-09-16
Valid Till : 2025-09-15
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 08
Issue Date : 2025-02-03
Type : Chemical
Substance Number : 542
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-09-15
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 : 2022-09-16
Valid Till : 2025-09-15
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 : 2022-09-16
Valid Till : 2025-09-15
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 : 2022-09-16
Valid Till : 2025-09-15
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 : 2022-09-16
Valid Till : 2025-09-15
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 : 2022-09-16
Valid Till : 2025-09-15
Written Confirmation Number : WC-0115
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2007-338 - Rev 03
Issue Date : 2023-01-09
Type : Chemical
Substance Number : 2334
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-09-15
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 : 2022-09-16
Valid Till : 2025-09-15
Written Confirmation Number : WC-0115
Address of the Firm :
Fresenius Kabi Oncology Limited is a supplier offers 35 products (APIs, Excipients or Intermediates).
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