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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Polymed Therapeutics Inc.

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01 Azacitidine (1)

02 Bortezomib (1)

03 Cabazitaxel (2)

04 Carfilzomib (1)

05 Docetaxel (2)

06 Doxcercalciferol (1)

07 Irinotecan Hydrochloride (2)

08 Methanesulphonic acid (1)

09 Oxaliplatin (1)

10 Paclitaxel (2)

11 Pemetrexed Disodium (1)

12 Vitamin D3 (2)

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01 Active (5)

02 Inactive (12)

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01 Valid (3)

02 Withdrawn by Holder (3)

03 Blank (11)

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01 224MF10086 (1)

02 225MF10121 (1)

03 227MF10008 (1)

04 Blank (14)

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01 Blank (17)

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USDMF

Caution USDMF

20961
Inactive
DOCETAXEL ANHYDROUS, NON-STERILE BU...
2007-10-22
CEP/COS

Found CEP/COS

R1-CEP 2012-029 - Rev 01
Valid
Docetaxel
2019-03-25
Japanese DMF

Found JDMF

227MF10008
Docetaxel hydrate at No. 105, Jiran...
2015-01-05
Written Confirmation

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Application Number
20961
227MF10008
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
DOCETAXEL ANHYDROUS, NON-STERILE BU...
Docetaxel
Docetaxel hydrate at No. 105, Jiran...
Issue/Submission Date
2007-10-22
2019-03-25
2015-01-05
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USDMF

Caution USDMF

21040
Inactive
DOCETAXEL TRIHYDRATE DRUG SUBSTANCE
2007-11-15
CEP/COS

Caution CEP/COS

R0-CEP 2013-074 - Rev 02
Withdrawn by Holder
Docetaxel trihydrate
2017-10-27
Japanese DMF

Found JDMF

224MF10086
Docetaxel at No. 105, Jirang Jiang ...
2012-04-13
Written Confirmation

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Application Number
21040
224MF10086
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
DOCETAXEL TRIHYDRATE DRUG SUBSTANCE
Docetaxel trihydrate
Docetaxel at No. 105, Jirang Jiang ...
Issue/Submission Date
2007-11-15
2017-10-27
2012-04-13
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USDMF

Caution USDMF

20897
Inactive
OXALIPLATIN, NON-STERILE BULK DRUG ...
2007-09-27
CEP/COS

Caution CEP/COS

R1-CEP 2010-164 - Rev 00
Withdrawn by Holder
Oxaliplatin
2017-10-17
Japanese DMF

Found JDMF

225MF10121
Oxaliplatin at No. 105, Jirang Jian...
2013-06-18
Written Confirmation

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Application Number
20897
225MF10121
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
OXALIPLATIN, NON-STERILE BULK DRUG ...
Oxaliplatin
Oxaliplatin at No. 105, Jirang Jian...
Issue/Submission Date
2007-09-27
2017-10-17
2013-06-18
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USDMF

Caution USDMF

18397
Inactive
PACLITAXEL DRUG SUBSTANCE
2005-05-23
CEP/COS

Found CEP/COS

R1-CEP 2014-192 - Rev 00
Valid
Paclitaxel, Produced by a semi-synt...
2021-06-29
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
18397
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
PACLITAXEL DRUG SUBSTANCE
Paclitaxel, Produced by a semi-synt...
Issue/Submission Date
2005-05-23
2021-06-29
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USDMF

Caution USDMF

27900
Inactive
PACLITAXEL USP (SEMI-SYNTHETIC)
2014-01-09
CEP/COS

Found CEP/COS

R1-CEP 2010-143 - Rev 01
Valid
Paclitaxel, isolated from natural s...
2019-04-17
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
27900
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
PACLITAXEL USP (SEMI-SYNTHETIC)
Paclitaxel, isolated from natural s...
Issue/Submission Date
2014-01-09
2019-04-17
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USDMF

Found USDMF

19489
Active
CHOLECALCIFEROL CRYSTAL (NON-STERIL...
2006-05-30
CEP/COS

Caution CEP/COS

R0-CEP 2013-282 - Rev 00
Withdrawn by Holder
Cholecalciferol
2015-09-10
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
19489
Status
Active
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
CHOLECALCIFEROL CRYSTAL (NON-STERIL...
Cholecalciferol
Issue/Submission Date
2006-05-30
2015-09-10
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USDMF

Found USDMF

28107
Active
AZACITIDINE USP
2014-03-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

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Application Number
28107
Status
Active
Fees Paid
Reviewed
 
Filing Details
AZACITIDINE USP
Issue/Submission Date
2014-03-12
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USDMF

Found USDMF

30357
Active
CARFILZOMIB DRUG SUBSTANCE
2016-02-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30357
Status
Active
Fees Paid
N/A
 
Filing Details
CARFILZOMIB DRUG SUBSTANCE
Issue/Submission Date
2016-02-26
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USDMF

Found USDMF

27809
Active
PEMETREXED DISODIUM 2.5 HYDRATE DRU...
2013-12-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
27809
Status
Active
Fees Paid
N/A
 
Filing Details
PEMETREXED DISODIUM 2.5 HYDRATE DRU...
Issue/Submission Date
2013-12-06
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USDMF

Found USDMF

20524
Active
CHOLECALCIFEROL CONCENTRATE (POWDER...
2007-05-10
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
20524
Status
Active
Fees Paid
N/A
 
Filing Details
CHOLECALCIFEROL CONCENTRATE (POWDER...
Issue/Submission Date
2007-05-10
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