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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fresenius Kabi Oncology Limited

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01 Afatinib (1)

02 Alectinib Hydrochloride (1)

03 Anastrozole (1)

04 Belinostat (1)

05 Bendamustine Hydrochloride (1)

06 Bicalutamide (1)

07 Bortezomib (1)

08 Buflomedil (1)

09 Busulfan (1)

10 Cabazitaxel (1)

11 Carboplatin (1)

12 Carfilzomib (1)

13 Cisplatin (1)

14 Decitabine (1)

15 Docetaxel (2)

16 Erlotinib Hydrochloride (1)

17 Gefitinib (1)

18 Gemcitabine (3)

19 Ibrutinib (1)

20 Imatinib Mesylate (1)

21 Irinotecan Hydrochloride (1)

22 Letrozole (1)

23 Levobupivacaine (1)

24 Metaxalone (1)

25 Oxaliplatin (1)

26 Paclitaxel (1)

27 Pemetrexed Disodium (1)

28 Plerixafor (1)

29 Ribociclib (1)

30 Ropivacaine Hydrochloride (2)

31 Sugammadex Sodium (1)

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01 Inactive (10)

02 Blank (25)

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01 Valid (13)

02 Withdrawn by Holder (3)

03 Blank (19)

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01 Blank (35)

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01 WC-0115 (19)

02 WC-0115A3 (6)

03 Blank (10)

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USDMF

Caution USDMF

30927
Inactive
AFATINIB DIMALEATE
2016-12-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0115A3
Valid
Afatinib Dimaleate IH at D-35, Indu...
2022-09-30
Application Number
30927
Indian CDSCO WC-0115A3
Status
Inactive
Fees Paid
N/A
 
Valid
2025-09-15
Filing Details
AFATINIB DIMALEATE
Afatinib Dimaleate IH at D-35, Indu...
Issue/Submission Date
2016-12-31
2022-09-30
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USDMF

Caution USDMF

33869
Inactive
ALECTINIB HYDROCHLORIDE
2019-06-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0115A3
Valid
Alectinib Hydrochloride IH at D-35,...
2022-09-30
Application Number
33869
Indian CDSCO WC-0115A3
Status
Inactive
Fees Paid
N/A
 
Valid
2025-09-15
Filing Details
ALECTINIB HYDROCHLORIDE
Alectinib Hydrochloride IH at D-35,...
Issue/Submission Date
2019-06-12
2022-09-30
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2012-369 - Rev 00
Valid
Bicalutamide
2021-05-20
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0115
Expired
Bicalutamide (USP/IH) at D-35, Indu...
2019-07-08
Application Number
Indian CDSCO WC-0115
Status
Valid
 
Expired
2022-07-07
Filing Details
Bicalutamide
Bicalutamide (USP/IH) at D-35, Indu...
Issue/Submission Date
2021-05-20
2019-07-08
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USDMF

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CEP/COS

Found CEP/COS

CEP 2010-374 - Rev 07
Valid
Busulfan
2023-10-13
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0115
Expired
Busulfan (USP/EP/BP) at D-35, Indus...
2019-07-08
Application Number
Indian CDSCO WC-0115
Status
Valid
 
Expired
2022-07-07
Filing Details
Busulfan
Busulfan (USP/EP/BP) at D-35, Indus...
Issue/Submission Date
2023-10-13
2019-07-08
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2001-282 - Rev 13
Valid
Carboplatin
2022-03-07
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0115
Expired
Carboplatin (Ph. Eur./USP) at D-35,...
2019-07-08
Application Number
Indian CDSCO WC-0115
Status
Valid
 
Expired
2022-07-07
Filing Details
Carboplatin
Carboplatin (Ph. Eur./USP) at D-35,...
Issue/Submission Date
2022-03-07
2019-07-08
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USDMF

Caution USDMF

29750
Inactive
CARFILZOMIB
2016-01-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0115A3
Valid
Carfilzomib IH at D-35, Industrial ...
2022-09-30
Application Number
29750
Indian CDSCO WC-0115A3
Status
Inactive
Fees Paid
N/A
 
Valid
2025-09-15
Filing Details
CARFILZOMIB
Carfilzomib IH at D-35, Industrial ...
Issue/Submission Date
2016-01-30
2022-09-30
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USDMF

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CEP/COS

Found CEP/COS

CEP 2012-293 - Rev 02
Valid
Docetaxel
2023-11-17
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0115
Expired
Docetaxel Anhydrous(USP)/Docetaxel ...
2019-07-08
Application Number
Indian CDSCO WC-0115
Status
Valid
 
Expired
2022-07-07
Filing Details
Docetaxel
Docetaxel Anhydrous(USP)/Docetaxel ...
Issue/Submission Date
2023-11-17
2019-07-08
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2012-080 - Rev 01
Valid
Gemcitabine hydrochloride, Alternat...
2019-10-08
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0115
Expired
Gemcitabine Hydrochloride (Ph. Eur....
2019-07-08
Application Number
Indian CDSCO WC-0115
Status
Valid
 
Expired
2022-07-07
Filing Details
Gemcitabine hydrochloride, Alternat...
Gemcitabine Hydrochloride (Ph. Eur....
Issue/Submission Date
2019-10-08
2019-07-08
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USDMF

Caution USDMF

31199
Inactive
IBRUTINIB
2017-05-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0115A3
Valid
Ibrutinib IH at D-35, Industrial Ar...
2022-09-30
Application Number
31199
Indian CDSCO WC-0115A3
Status
Inactive
Fees Paid
N/A
 
Valid
2025-09-15
Filing Details
IBRUTINIB
Ibrutinib IH at D-35, Industrial Ar...
Issue/Submission Date
2017-05-12
2022-09-30
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

CEP 2017-234 - Rev 03
Valid
Irinotecan hydrochloride trihydrate
2024-04-22
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0115
Expired
Irinotecan Hydrochloride Trihydrate...
2019-07-08
Application Number
Indian CDSCO WC-0115
Status
Valid
 
Expired
2022-07-07
Filing Details
Irinotecan hydrochloride trihydrate
Irinotecan Hydrochloride Trihydrate...
Issue/Submission Date
2024-04-22
2019-07-08
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