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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Nexchem Pharmaceutical Co, Ltd

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01 Azithromycin (1)

02 Benserazide Hydrochloride (1)

03 Capecitabine (1)

04 Clarithromycin (1)

05 Dacarbazine (1)

06 Fenofibrate (1)

07 Glimepiride (1)

08 Hydrochlorothiazide (1)

09 Idebenone (1)

10 Indapamide (1)

11 Nilotinib (1)

12 Pemetrexed Disodium (2)

13 Temozolomide (1)

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01 Active (3)

02 Inactive (1)

03 Blank (10)

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01 Valid (13)

02 Blank (1)

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01 219MF10312 (1)

02 219MF10331 (1)

03 Blank (12)

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01 Blank (14)

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USDMF

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CEP/COS

Found CEP/COS

CEP 2021-069 - Rev 00
Valid
Azithromycin
2023-09-20
Japanese DMF

Found JDMF

219MF10312
Azithromycin hydrate at No. 1318 Ji...
2007-10-05
Written Confirmation

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Application Number
219MF10312
Status
Valid
 
Filing Details
Azithromycin
Azithromycin hydrate at No. 1318 Ji...
Issue/Submission Date
2023-09-20
2007-10-05
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2006-314 - Rev 02
Valid
Clarithromycin
2022-01-04
Japanese DMF

Found JDMF

219MF10331
Clarithromycin at No. 1318 Jinsha s...
2007-11-20
Written Confirmation

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Application Number
219MF10331
Status
Valid
 
Filing Details
Clarithromycin
Clarithromycin at No. 1318 Jinsha s...
Issue/Submission Date
2022-01-04
2007-11-20
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USDMF

Found USDMF

31693
Active
NILOTINIB HYDROCHLORIDE MONOHYDRATE
2017-04-14
CEP/COS

Found CEP/COS

R0-CEP 2021-133 - Rev 00
Valid
Nilotinib hydrochloride monohydrate
2023-07-21
Japanese DMF

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Written Confirmation

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Application Number
31693
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Nilotinib hydrochloride monohydrate
Issue/Submission Date
2017-04-14
2023-07-21
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USDMF

Found USDMF

25640
Active
PEMETREXED DISODIUM (NON STERILE)
2011-12-27
CEP/COS

Found CEP/COS

R0-CEP 2021-072 - Rev 00
Valid
Pemetrexed disodium 2.5-hydrate
2022-07-08
Japanese DMF

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Written Confirmation

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Application Number
25640
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
PEMETREXED DISODIUM (NON STERILE)
Pemetrexed disodium 2.5-hydrate
Issue/Submission Date
2011-12-27
2022-07-08
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USDMF

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21181
Inactive
HYDROCHLOROTHIAZIDE
2007-12-31
CEP/COS

Found CEP/COS

CEP 2012-250 - Rev 02
Valid
Hydrochlorothiazide
2023-09-20
Japanese DMF

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Written Confirmation

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Application Number
21181
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
HYDROCHLOROTHIAZIDE
Hydrochlorothiazide
Issue/Submission Date
2007-12-31
2023-09-20
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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2018-299 - Rev 00
Valid
Benserazide hydrochloride
2022-03-03
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Benserazide hydrochloride
Issue/Submission Date
2022-03-03
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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2021-316 - Rev 00
Valid
Capecitabine
2022-10-19
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Capecitabine
Issue/Submission Date
2022-10-19
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-315 - Rev 02
Valid
Dacarbazine
2023-02-17
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Dacarbazine
Issue/Submission Date
2023-02-17
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2006-187 - Rev 01
Valid
Fenofibrate
2013-01-29
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Fenofibrate
Issue/Submission Date
2013-01-29
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2006-311 - Rev 00
Valid
Glimepiride
2013-01-30
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Glimepiride
Issue/Submission Date
2013-01-30
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