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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Icrom

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01 Alizapride Hydrochloride (1)

02 Amisulpride (2)

03 Bepotastine (1)

04 Binimetinib (1)

05 Bortezomib (1)

06 Brinzolamide (2)

07 Bromopride (1)

08 Diacerein (1)

09 Encorafenib (1)

10 Epinastine Hydrochloride (1)

11 Fluorescein (1)

12 Gliquidone (1)

13 Indocyanine Green (1)

14 Isavuconazonium Sulfate (1)

15 Isosulfan Blue (1)

16 Lenalidomide (1)

17 Levosulpiride (1)

18 Methylene Blue (1)

19 Metoclopramide (1)

20 Metoclopramide Hydrochloride (1)

21 Minoxidil (1)

22 Paliperidone Palmitate (1)

23 Pipoxolan Hydrochloride (1)

24 Procaine (1)

25 Racecadotril (1)

26 Risperidone (2)

27 Ropivacaine Hydrochloride (1)

28 Sulpiride (1)

29 Tiapride Hydrochloride (2)

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01 Active (10)

02 Inactive (2)

03 Blank (21)

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01 Valid (9)

02 Blank (24)

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01 218MF10084 (1)

02 218MF10085 (1)

03 226MF10231 (1)

04 227MF10074 (1)

05 229MF10040 (1)

06 231MF10086 (1)

07 Blank (27)

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01 Blank (33)

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USDMF

Found USDMF

31672
Active
AMISULPRIDE
2017-07-11
CEP/COS

Found CEP/COS

R1-CEP 2009-215 - Rev 02
Valid
Amisulpride
2021-06-16
Japanese DMF

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Written Confirmation

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Application Number
31672
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
AMISULPRIDE
Amisulpride
Issue/Submission Date
2017-07-11
2021-06-16
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USDMF

Found USDMF

25478
Active
BRINZOLAMIDE (MICRONIZED, MICRONIZE...
2011-11-07
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

231MF10086
Brinzolamide at Via Delle Arti 33, ...
2019-04-11
Written Confirmation

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Application Number
25478
231MF10086
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
BRINZOLAMIDE (MICRONIZED, MICRONIZE...
Brinzolamide at Via Delle Arti 33, ...
Issue/Submission Date
2011-11-07
2019-04-11
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USDMF

Found USDMF

21830
Active
EPINASTINE HYDROCHLORIDE
2008-07-28
CEP/COS

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Japanese DMF

Found JDMF

226MF10231
Epinastine hydrochloride at Via Del...
2014-12-08
Written Confirmation

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Application Number
21830
226MF10231
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
EPINASTINE HYDROCHLORIDE
Epinastine hydrochloride at Via Del...
Issue/Submission Date
2008-07-28
2014-12-08
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USDMF

Found USDMF

29144
Active
FLUORESCEIN SODIUM
2015-03-05
CEP/COS

Found CEP/COS

R1-CEP 2017-121 - Rev 00
Valid
Fluorescein Sodium
2023-07-03
Japanese DMF

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Written Confirmation

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Application Number
29144
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
FLUORESCEIN SODIUM
Fluorescein Sodium
Issue/Submission Date
2015-03-05
2023-07-03
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USDMF

Found USDMF

36307
Active
METHYLENE BLUE
2021-12-02
CEP/COS

Found CEP/COS

CEP 2022-296 - Rev 00
Valid
Methylthioninium chloride hydrate
2023-12-18
Japanese DMF

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Written Confirmation

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Application Number
36307
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
METHYLENE BLUE
Methylthioninium chloride hydrate
Issue/Submission Date
2021-12-02
2023-12-18
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USDMF

Found USDMF

32884
Active
METOCLOPRAMIDE HCL
2018-06-19
CEP/COS

Found CEP/COS

R1-CEP 2015-304 - Rev 00
Valid
Metoclopramide Hydrochloride monohy...
2021-05-20
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
32884
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
METOCLOPRAMIDE HCL
Metoclopramide Hydrochloride monohy...
Issue/Submission Date
2018-06-19
2021-05-20
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USDMF

Found USDMF

17270
Active
MINOXIDIL
2004-03-23
CEP/COS

Found CEP/COS

R0-CEP 2020-392 - Rev 01
Valid
Minoxidil
2023-06-02
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
17270
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
MINOXIDIL
Minoxidil
Issue/Submission Date
2004-03-23
2023-06-02
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2011-074 - Rev 03
Valid
Sulpiride
2023-03-13
Japanese DMF

Found JDMF

218MF10084
Japan Bureau Sulpiride (for manufac...
2006-01-27
Written Confirmation

Close WC

Application Number
218MF10084
Status
Valid
 
Filing Details
Sulpiride
Japan Bureau Sulpiride (for manufac...
Issue/Submission Date
2023-03-13
2006-01-27
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

CEP 2023-003 - Rev 00
Valid
Tiapride hydrochloride
2024-01-19
Japanese DMF

Found JDMF

227MF10074
Tiapride hydrochloride at Via Delle...
2015-03-12
Written Confirmation

Close WC

Application Number
227MF10074
Status
Valid
 
Filing Details
Tiapride hydrochloride
Tiapride hydrochloride at Via Delle...
Issue/Submission Date
2024-01-19
2015-03-12
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USDMF

Caution USDMF

25523
Inactive
AMISULPRIDE
2011-11-24
CEP/COS

Found CEP/COS

CEP 2019-051 - Rev 03
Valid
Amisulpride, Process 2
2023-11-21
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25523
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
AMISULPRIDE
Amisulpride, Process 2
Issue/Submission Date
2011-11-24
2023-11-21
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