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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Alembic Pharmaceuticals Limited

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    ALEMBIC PHARMACEUTICALS LIMITED

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    Alembic Pharmaceuticals Limited
    india-flag Flag
    Country
    Country
    India
    Address
    Address
    Alembic Road, Vadodara - 390 003, Gujarat
    Telephone
    Telephone
    91 - 265 - 228 0550
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.alembic-india.com/
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    Linkedin
    https://www.linkedin.com/company-beta/45834/?pathWildcard=45834
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    Twitter

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    • FDA
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    Fenofibrate

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    USDMF

    Found USDMF

    16208
    Active
    FENOFIBRATE USP
    2002-10-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-017 - Rev 00
    Valid
    Fenofibrate, Process-II
    2021-11-19
    Japanese DMF

    Found JDMF

    228MF10151
    Fenofibrate at Alembic Road, Vadoda...
    2016-08-08
    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Fenofibrate EP
    2022-06-17
    Application Number
    16208
    R1-CEP 2016-017 - Rev 00
    228MF10151
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FENOFIBRATE USP
    Fenofibrate, Process-II
    Fenofibrate at Alembic Road, Vadoda...
    Fenofibrate EP
    Issue/Submission Date
    2002-10-25
    2021-11-19
    2016-08-08
    2022-06-17
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    Olmesartan Medoxomil

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    USDMF

    Found USDMF

    24671
    Active
    OLMESARTAN MEDOXOMIL USP
    2011-02-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-297 - Rev 01
    Valid
    Olmesartan medoxomil
    2023-05-12
    Japanese DMF

    Found JDMF

    227MF10284
    Olmesartan Medoxomil at Alembic Roa...
    2015-12-15
    Written Confirmation

    Found WC

    Indian CDSCO WC-0083
    Valid
    Olmesartan Medoxomil EP
    2022-06-03
    Application Number
    24671
    R1-CEP 2013-297 - Rev 01
    227MF10284
    Indian CDSCO WC-0083
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Olmesartan medoxomil
    Olmesartan Medoxomil at Alembic Roa...
    Olmesartan Medoxomil EP
    Issue/Submission Date
    2011-02-25
    2023-05-12
    2015-12-15
    2022-06-03
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    Ropinirole Hydrochloride

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    USDMF

    Found USDMF

    19780
    Active
    ROPINIROLE HYDROCHLORIDE USP
    2006-09-11
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-227 - Rev 00
    Valid
    Ropinirole hydrochloride
    2023-08-09
    Japanese DMF

    Found JDMF

    228MF10173
    ROPINIROLE HYDROCHLORIDE at Alembic...
    2016-08-29
    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Ropinirole Hydrochloride (USP)
    2022-06-17
    Application Number
    19780
    R0-CEP 2022-227 - Rev 00
    228MF10173
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ROPINIROLE HYDROCHLORIDE USP
    Ropinirole hydrochloride
    ROPINIROLE HYDROCHLORIDE at Alembic...
    Ropinirole Hydrochloride (USP)
    Issue/Submission Date
    2006-09-11
    2023-08-09
    2016-08-29
    2022-06-17
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    Telmisartan

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    USDMF

    Found USDMF

    20285
    Active
    TELMISARTAN USP
    2007-02-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-217 - Rev 07
    Valid
    Telmisartan
    2022-05-16
    Japanese DMF

    Found JDMF

    231MF10053
    Telmisartan at Alembic Road, Vadoda...
    2019-02-21
    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Telmisartan Ph. Eur
    2022-06-17
    Application Number
    20285
    R1-CEP 2008-217 - Rev 07
    231MF10053
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    TELMISARTAN USP
    Telmisartan
    Telmisartan at Alembic Road, Vadoda...
    Telmisartan Ph. Eur
    Issue/Submission Date
    2007-02-07
    2022-05-16
    2019-02-21
    2022-06-17
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    • FDA
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    Vardenafil Hydrochloride

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    USDMF

    Found USDMF

    28900
    Active
    VARDENAFIL HYDROCHLORIDE USP
    2014-12-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-095 - Rev 01
    Valid
    Vardenafil hydrochloride trihydrate
    2023-06-26
    Japanese DMF

    Found JDMF

    301MF10002
    Vardenafil Hydrochloride Trihydrate...
    2019-05-08
    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Vardenafil Hydrochloride Trihydrate
    2022-06-17
    Application Number
    28900
    R1-CEP 2015-095 - Rev 01
    301MF10002
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VARDENAFIL HYDROCHLORIDE USP
    Vardenafil hydrochloride trihydrate
    Vardenafil Hydrochloride Trihydrate...
    Vardenafil Hydrochloride Trihydrate
    Issue/Submission Date
    2014-12-31
    2023-06-26
    2019-05-08
    2022-06-17
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    Lamotrigine

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    USDMF

    Found USDMF

    18732
    Active
    LAMOTRIGINE USP
    2005-09-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-010 - Rev 03
    Valid
    Lamotrigine
    2023-06-19
    Japanese DMF

    Found JDMF

    229MF10012
    Lamotrigine at Alembic Road, Vadoda...
    2017-01-23
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Lamotrigine (EP)
    2019-07-05
    Application Number
    18732
    R1-CEP 2011-010 - Rev 03
    229MF10012
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    LAMOTRIGINE USP
    Lamotrigine
    Lamotrigine at Alembic Road, Vadoda...
    Lamotrigine (EP)
    Issue/Submission Date
    2005-09-09
    2023-06-19
    2017-01-23
    2019-07-05
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    Venlafaxine Hydrochloride

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    USDMF

    Caution USDMF

    16551
    Inactive
    VENLAFAXINE HYDROCHLORIDE
    2003-04-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-270 - Rev 07
    Valid
    Venlafaxine hydrochloride, Form B
    2023-01-27
    Japanese DMF

    Found JDMF

    304MF10131
    Venlafaxine Hydrochloride at Alembi...
    2022-09-21
    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Venlafaxine Hydrochloride EP
    2022-06-17
    Application Number
    16551
    R1-CEP 2009-270 - Rev 07
    304MF10131
    Indian CDSCO WC-0082
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VENLAFAXINE HYDROCHLORIDE
    Venlafaxine hydrochloride, Form B
    Venlafaxine Hydrochloride at Alembi...
    Venlafaxine Hydrochloride EP
    Issue/Submission Date
    2003-04-29
    2023-01-27
    2022-09-21
    2022-06-17
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    Aripiprazole

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    USDMF

    Found USDMF

    23300
    Active
    ARIPIPRAZOLE USP
    2009-11-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-292 - Rev 01
    Valid
    Aripiprazole
    2023-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Aripiprazole Ph. Eur
    2022-06-17
    Application Number
    23300
    R1-CEP 2013-292 - Rev 01
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ARIPIPRAZOLE USP
    Aripiprazole
    Aripiprazole Ph. Eur
    Issue/Submission Date
    2009-11-18
    2023-01-25
    2022-06-17
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    Celecoxib

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    USDMF

    Found USDMF

    24419
    Active
    CELECOXIB USP
    2010-11-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-388 - Rev 03
    Valid
    Celecoxib
    2022-03-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0083
    Valid
    Celecoxib EP
    2022-06-03
    Application Number
    24419
    R1-CEP 2012-388 - Rev 03
    Indian CDSCO WC-0083
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CELECOXIB USP
    Celecoxib
    Celecoxib EP
    Issue/Submission Date
    2010-11-30
    2022-03-29
    2022-06-03
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    Clarithromycin

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    USDMF

    Caution USDMF

    16746
    Inactive
    CLARITHROMYCIN
    2003-08-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-169 - Rev 02
    Valid
    Clarithromycin
    2019-01-28
    Japanese DMF

    Found JDMF

    221MF10008
    Clarithromycin at Alembic Road, Vad...
    2009-01-13
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Ciarithromycin (EP)
    2019-07-05
    Application Number
    16746
    R1-CEP 2007-169 - Rev 02
    221MF10008
    Indian CDSCO WC-0081
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    CLARITHROMYCIN
    Clarithromycin
    Clarithromycin at Alembic Road, Vad...
    Ciarithromycin (EP)
    Issue/Submission Date
    2003-08-07
    2019-01-28
    2009-01-13
    2019-07-05
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    Deferasirox

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    USDMF

    Found USDMF

    26833
    Active
    DEFERASIROX
    2013-02-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-170 - Rev 02
    Valid
    Deferasirox
    2023-03-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Deferasirox/DeferasiroxEP
    2022-06-17
    Application Number
    26833
    R0-CEP 2021-170 - Rev 02
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    DEFERASIROX
    Deferasirox
    Deferasirox/DeferasiroxEP
    Issue/Submission Date
    2013-02-27
    2023-03-30
    2022-06-17
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    • FDA
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    Donepezil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23426
    Active
    DONEPEZIL HYDROCHLORIDE MONOHYDRATE...
    2009-12-31
    CEP/COS

    Found CEP/COS

    CEP 2022-079 - Rev 01
    Valid
    Donepezil hydrochloride monohydrate...
    2023-12-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Donepezil Hydrochloride
    2022-06-17
    Application Number
    23426
    CEP 2022-079 - Rev 01
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    DONEPEZIL HYDROCHLORIDE MONOHYDRATE...
    Donepezil hydrochloride monohydrate...
    Donepezil Hydrochloride
    Issue/Submission Date
    2009-12-31
    2023-12-18
    2022-06-17
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    Duloxetine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23702
    Active
    DULOXETINE HYDROCHLORIDE USP
    2010-04-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-118 - Rev 03
    Valid
    Duloxetine hydrochloride
    2023-07-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Duloxetine Hydrochloride (Ph. Eur.)
    2022-06-17
    Application Number
    23702
    R1-CEP 2012-118 - Rev 03
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    DULOXETINE HYDROCHLORIDE USP
    Duloxetine hydrochloride
    Duloxetine Hydrochloride (Ph. Eur.)
    Issue/Submission Date
    2010-04-09
    2023-07-27
    2022-06-17
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    Febuxostat

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26417
    Active
    FEBUXOSTAT
    2012-10-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10156
    Febuxostat at Alembic Road, Vadodar...
    2020-12-18
    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Febuxostat
    2022-06-17
    Application Number
    26417
    302MF10156
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    FEBUXOSTAT
    Febuxostat at Alembic Road, Vadodar...
    Febuxostat
    Issue/Submission Date
    2012-10-01
    2020-12-18
    2022-06-17
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    Felodipine

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    USDMF

    Found USDMF

    25373
    Active
    FELODIPINE USP
    2011-10-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-307 - Rev 02
    Valid
    Felodipine
    2023-08-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Felodipine (EP)
    2022-06-17
    Application Number
    25373
    R1-CEP 2013-307 - Rev 02
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FELODIPINE USP
    Felodipine
    Felodipine (EP)
    Issue/Submission Date
    2011-10-11
    2023-08-09
    2022-06-17
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    Fingolimod Hydrochloride

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    USDMF

    Found USDMF

    28057
    Active
    FINGOLIMOD HYDROCHLORIDE USP
    2014-03-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-301 - Rev 01
    Valid
    Fingolimod hydrochloride
    2022-11-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Fingolimod Hydrochloride IH
    2022-06-17
    Application Number
    28057
    R0-CEP 2019-301 - Rev 01
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FINGOLIMOD HYDROCHLORIDE USP
    Fingolimod hydrochloride
    Fingolimod Hydrochloride IH
    Issue/Submission Date
    2014-03-28
    2022-11-18
    2022-06-17
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    Fluphenazine

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    USDMF

    Found USDMF

    35366
    Active
    FLUPHENAZINE HYDROCHLORIDE USP
    2020-12-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-427 - Rev 00
    Valid
    Fluphenazine dihydrochloride
    2022-09-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082A3
    Valid
    Fluphenazine dihydrochloride EP
    2022-07-15
    Application Number
    35366
    R0-CEP 2020-427 - Rev 00
    Indian CDSCO WC-0082A3
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FLUPHENAZINE HYDROCHLORIDE USP
    Fluphenazine dihydrochloride
    Fluphenazine dihydrochloride EP
    Issue/Submission Date
    2020-12-30
    2022-09-13
    2022-07-15
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    Gefitinib

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    USDMF

    Found USDMF

    30868
    Active
    GEFITINIB
    2016-09-19
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-087 - Rev 00
    Valid
    Gefitinib
    2019-02-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Gefitinib EP
    2022-06-17
    Application Number
    30868
    R0-CEP 2018-087 - Rev 00
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    GEFITINIB
    Gefitinib
    Gefitinib EP
    Issue/Submission Date
    2016-09-19
    2019-02-05
    2022-06-17
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    Irbesartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20378
    Active
    IRBESARTAN USP
    2007-03-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-153 - Rev 04
    Valid
    Irbesartan
    2023-03-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0083
    Valid
    Irbesartan EP
    2022-06-03
    Application Number
    20378
    R1-CEP 2011-153 - Rev 04
    Indian CDSCO WC-0083
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    IRBESARTAN USP
    Irbesartan
    Irbesartan EP
    Issue/Submission Date
    2007-03-19
    2023-03-16
    2022-06-03
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    • FDA
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    Lacosamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26349
    Active
    LACOSAMIDE USP
    2012-09-07
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-276 - Rev 01
    Valid
    Lacosamide
    2020-09-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Lacosamide EP
    2022-06-17
    Application Number
    26349
    R0-CEP 2018-276 - Rev 01
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LACOSAMIDE USP
    Lacosamide
    Lacosamide EP
    Issue/Submission Date
    2012-09-07
    2020-09-25
    2022-06-17
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    Linagliptin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31452
    Active
    LINAGLIPTIN
    2017-03-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10137
    Linagliptin at Alembic Road, Vadoda...
    2023-12-19
    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Linagliptin IH
    2022-06-17
    Application Number
    31452
    305MF10137
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    LINAGLIPTIN
    Linagliptin at Alembic Road, Vadoda...
    Linagliptin IH
    Issue/Submission Date
    2017-03-30
    2023-12-19
    2022-06-17
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    Losartan Potassium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22116
    Active
    LOSARTAN POTASSIUM USP
    2008-10-21
    CEP/COS

    Found CEP/COS

    CEP 2009-102 - Rev 05
    Valid
    Losartan potassium
    2023-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0083
    Valid
    Losartan Potassium EP
    2022-06-03
    Application Number
    22116
    CEP 2009-102 - Rev 05
    Indian CDSCO WC-0083
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LOSARTAN POTASSIUM USP
    Losartan potassium
    Losartan Potassium EP
    Issue/Submission Date
    2008-10-21
    2023-11-17
    2022-06-03
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    Mexiletine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    24714
    Active
    MEXILETINE HYDROCHLORIDE USP
    2011-03-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-057 - Rev 01
    Valid
    Mexiletine hydrochloride
    2021-01-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082A3
    Valid
    MEXILETINE HYDROCHLORIDE EP
    2022-07-15
    Application Number
    24714
    R1-CEP 2014-057 - Rev 01
    Indian CDSCO WC-0082A3
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    MEXILETINE HYDROCHLORIDE USP
    Mexiletine hydrochloride
    MEXILETINE HYDROCHLORIDE EP
    Issue/Submission Date
    2011-03-09
    2021-01-11
    2022-07-15
    ASK
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    • FDA
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    Modafinil

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    16477
    Active
    MODAFINIL USP
    2003-03-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-073 - Rev 00
    Valid
    Modafinil
    2021-01-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Modafinil EP
    2022-06-17
    Application Number
    16477
    R1-CEP 2014-073 - Rev 00
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    MODAFINIL USP
    Modafinil
    Modafinil EP
    Issue/Submission Date
    2003-03-21
    2021-01-14
    2022-06-17
    ASK
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    your Marketing & Sales content
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    Pirfenidone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    32772
    Active
    PIRFENIDONE
    2018-06-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-147 - Rev 01
    Valid
    Pirfenidone
    2023-02-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Pirfenidone IH/EP
    2022-06-17
    Application Number
    32772
    R0-CEP 2018-147 - Rev 01
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Pirfenidone IH/EP
    Issue/Submission Date
    2018-06-28
    2023-02-01
    2022-06-17
    ASK
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    your Marketing & Sales content
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    Pramipexole Dihydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    18836
    Active
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    2005-10-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-190 - Rev 00
    Valid
    Pramipexole dihydrochloride monohyd...
    2018-04-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Pramipexole Dihydrochloride Monohyd...
    2022-06-17
    Application Number
    18836
    R1-CEP 2011-190 - Rev 00
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    Pramipexole dihydrochloride monohyd...
    Pramipexole Dihydrochloride Monohyd...
    Issue/Submission Date
    2005-10-06
    2018-04-20
    2022-06-17
    ASK
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    your Marketing & Sales content
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    Prasugrel Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25898
    Active
    PRASUGREL HYDROCHLORIDE
    2012-03-21
    CEP/COS

    Found CEP/COS

    CEP 2020-434 - Rev 01
    Valid
    Prasugrel hydrochloride
    2024-01-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Prasugrel Hydrochloride
    2022-06-17
    Application Number
    25898
    CEP 2020-434 - Rev 01
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PRASUGREL HYDROCHLORIDE
    Prasugrel hydrochloride
    Prasugrel Hydrochloride
    Issue/Submission Date
    2012-03-21
    2024-01-04
    2022-06-17
    ASK
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    your Marketing & Sales content
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    Pregabalin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    24292
    Active
    PREGABALIN USP
    2010-09-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-220 - Rev 00
    Valid
    Pregabalin
    2022-06-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Pregabalin (EP)
    2022-06-17
    Application Number
    24292
    R1-CEP 2016-220 - Rev 00
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PREGABALIN USP
    Pregabalin
    Pregabalin (EP)
    Issue/Submission Date
    2010-09-30
    2022-06-13
    2022-06-17
    ASK
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    your Marketing & Sales content
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    • FDA
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    Rivaroxaban

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    28056
    Active
    RIVAROXABAN
    2014-03-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-238 - Rev 00
    Valid
    Rivaroxaban
    2023-04-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Rivaroxaban
    2022-06-17
    Application Number
    28056
    R0-CEP 2021-238 - Rev 00
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    RIVAROXABAN
    Rivaroxaban
    Rivaroxaban
    Issue/Submission Date
    2014-03-28
    2023-04-12
    2022-06-17
    ASK
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    your Marketing & Sales content
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    • FDA
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    Solifenacin Succinate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    25887
    Active
    SOLIFENACIN SUCCINATE
    2012-04-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-131 - Rev 00
    Valid
    Solifenacin succinate
    2022-05-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Solifenacin Succinate (EP)
    2022-06-17
    Application Number
    25887
    R1-CEP 2016-131 - Rev 00
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin succinate
    Solifenacin Succinate (EP)
    Issue/Submission Date
    2012-04-02
    2022-05-09
    2022-06-17
    ASK
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    your Marketing & Sales content
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    • FDA
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    Tadalafil

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    22707
    Active
    TADALAFIL USP
    2009-03-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-316 - Rev 00
    Valid
    Tadalafil
    2018-09-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Tadalafil (Ph Eur.)
    2022-06-17
    Application Number
    22707
    R1-CEP 2011-316 - Rev 00
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    TADALAFIL USP
    Tadalafil
    Tadalafil (Ph Eur.)
    Issue/Submission Date
    2009-03-31
    2018-09-06
    2022-06-17
    ASK
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    your Marketing & Sales content
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    • FDA
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    Theophylline

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    35365
    Active
    THEOPHYLLINE (ANHYDROUS) USP
    2020-12-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-425 - Rev 00
    Valid
    Theophylline
    2023-05-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082A3
    Valid
    Theophylline EP
    2022-07-15
    Application Number
    35365
    R0-CEP 2020-425 - Rev 00
    Indian CDSCO WC-0082A3
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    THEOPHYLLINE (ANHYDROUS) USP
    Theophylline
    Theophylline EP
    Issue/Submission Date
    2020-12-29
    2023-05-31
    2022-07-15
    ASK
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    your Marketing & Sales content
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    • FDA
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    Ticagrelor

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    28899
    Active
    TICAGRELOR
    2015-01-09
    CEP/COS

    Found CEP/COS

    CEP 2021-408 - Rev 01
    Valid
    Ticagrelor
    2024-01-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Ticagrelor (IH)
    2022-06-17
    Application Number
    28899
    CEP 2021-408 - Rev 01
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    TICAGRELOR
    Ticagrelor
    Ticagrelor (IH)
    Issue/Submission Date
    2015-01-09
    2024-01-09
    2022-06-17
    ASK
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    your Marketing & Sales content
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    • FDA
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    Warfarin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    24712
    Active
    WARFARIN SODIUM AMORPHOUS USP
    2011-03-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-233 - Rev 00
    Valid
    Warfarin sodium
    2020-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Warfarin Sodium (EP)
    2022-06-17
    Application Number
    24712
    R1-CEP 2013-233 - Rev 00
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    WARFARIN SODIUM AMORPHOUS USP
    Warfarin sodium
    Warfarin Sodium (EP)
    Issue/Submission Date
    2011-03-09
    2020-02-06
    2022-06-17
    ASK
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    your Marketing & Sales content
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    • FDA
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    Zolmitriptan

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    25503
    Active
    ZOLMITRIPTAN USP
    2011-12-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-255 - Rev 01
    Valid
    Zolmitriptan
    2022-07-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0082
    Valid
    Zolmitriptan
    2022-06-17
    Application Number
    25503
    R0-CEP 2018-255 - Rev 01
    Indian CDSCO WC-0082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ZOLMITRIPTAN USP
    Zolmitriptan
    Zolmitriptan
    Issue/Submission Date
    2011-12-20
    2022-07-11
    2022-06-17
    ASK
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    your Marketing & Sales content
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    • FDA
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    Azithromycin Dihydrate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    20754
    Active
    AZITHROMYCIN DIHYDRATE USP
    2007-07-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-165 - Rev 04
    Valid
    Azithromycin, Dihydrate
    2022-04-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Azithromycin Dihydrate (EP)
    2019-07-05
    Application Number
    20754
    R1-CEP 2007-165 - Rev 04
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    AZITHROMYCIN DIHYDRATE USP
    Azithromycin, Dihydrate
    Azithromycin Dihydrate (EP)
    Issue/Submission Date
    2007-07-30
    2022-04-06
    2019-07-05
    ASK
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    your Marketing & Sales content
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    • FDA
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    Clonidine

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    22362
    Active
    CLONIDINE HYDROCHLORIDE USP
    2008-12-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-039 - Rev 01
    Valid
    Clonidine hydrochloride
    2022-11-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Clonidine Hydrochloride (USP)/Cloni...
    2019-07-05
    Application Number
    22362
    R1-CEP 2014-039 - Rev 01
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    CLONIDINE HYDROCHLORIDE USP
    Clonidine hydrochloride
    Clonidine Hydrochloride (USP)/Cloni...
    Issue/Submission Date
    2008-12-24
    2022-11-29
    2019-07-05
    ASK
    US
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    your Marketing & Sales content
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    • FDA
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    Erythromycin

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    22695
    Active
    ERYTHROMYCIN USP
    2009-03-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-284 - Rev 00
    Valid
    Erythromycin
    2017-07-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Erythromycin (EP)
    2019-07-05
    Application Number
    22695
    R1-CEP 2009-284 - Rev 00
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ERYTHROMYCIN USP
    Erythromycin
    Erythromycin (EP)
    Issue/Submission Date
    2009-03-27
    2017-07-06
    2019-07-05
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    Famotidine

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    USDMF

    Found USDMF

    25581
    Active
    FAMOTIDINE USP
    2011-12-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-216 - Rev 00
    Valid
    Famotidine
    2022-01-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Famotidine (Ph. Eur.)
    2019-07-05
    Application Number
    25581
    R1-CEP 2015-216 - Rev 00
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    FAMOTIDINE USP
    Famotidine
    Famotidine (Ph. Eur.)
    Issue/Submission Date
    2011-12-12
    2022-01-18
    2019-07-05
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    Fenofibrate

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    USDMF

    Found USDMF

    23047
    Active
    FENOFIBRIC ACID CHOLINE SALT
    2009-08-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-219 - Rev 06
    Valid
    Fenofibrate
    2019-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Fenofibrate (EP)
    2019-07-05
    Application Number
    23047
    R1-CEP 2001-219 - Rev 06
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    FENOFIBRIC ACID CHOLINE SALT
    Fenofibrate
    Fenofibrate (EP)
    Issue/Submission Date
    2009-08-10
    2019-02-07
    2019-07-05
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    Fluoxetine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    25778
    Active
    FLUOXETINE HYDROCHLORIDE USP
    2012-02-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-199 - Rev 02
    Valid
    Fluoxetine hydrochloride
    2023-03-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Fluoxetine Hydrochloride (Ph.Eur.)
    2019-07-05
    Application Number
    25778
    R1-CEP 2013-199 - Rev 02
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    FLUOXETINE HYDROCHLORIDE USP
    Fluoxetine hydrochloride
    Fluoxetine Hydrochloride (Ph.Eur.)
    Issue/Submission Date
    2012-02-27
    2023-03-15
    2019-07-05
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    Hydrochlorothiazide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22253
    Active
    HYDROCHLOROTHIAZIDE USP
    2008-11-29
    CEP/COS

    Found CEP/COS

    CEP 2009-103 - Rev 05
    Valid
    Hydrochlorothiazide
    2023-10-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Hydrochlorothiazide (EP)
    2019-07-05
    Application Number
    22253
    CEP 2009-103 - Rev 05
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    HYDROCHLOROTHIAZIDE USP
    Hydrochlorothiazide
    Hydrochlorothiazide (EP)
    Issue/Submission Date
    2008-11-29
    2023-10-02
    2019-07-05
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    Leflunomide

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    USDMF

    Found USDMF

    16112
    Active
    LEFLUNOMIDE USP
    2002-08-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-172 - Rev 02
    Valid
    Leflunomide
    2018-09-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Leflunomide (EP)
    2019-07-05
    Application Number
    16112
    R1-CEP 2007-172 - Rev 02
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    LEFLUNOMIDE USP
    Leflunomide
    Leflunomide (EP)
    Issue/Submission Date
    2002-08-29
    2018-09-04
    2019-07-05
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    Memantine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23108
    Active
    MEMANTINE HYDROCHLORIDE USP
    2009-09-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10017
    Memantine Hydrochloride at Alembic ...
    2019-01-28
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Memantine HCl (IH)
    2019-07-05
    Application Number
    23108
    231MF10017
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    MEMANTINE HYDROCHLORIDE USP
    Memantine Hydrochloride at Alembic ...
    Memantine HCl (IH)
    Issue/Submission Date
    2009-09-11
    2019-01-28
    2019-07-05
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    Quetiapine Hemifumarate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23351
    Active
    QUETIAPINE FUMARATE USP
    2009-11-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-278 - Rev 01
    Valid
    Quetiapine Fumarate
    2023-06-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Quetiapine Fumarate (IH)
    2019-07-05
    Application Number
    23351
    R0-CEP 2020-278 - Rev 01
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    QUETIAPINE FUMARATE USP
    Quetiapine Fumarate
    Quetiapine Fumarate (IH)
    Issue/Submission Date
    2009-11-30
    2023-06-13
    2019-07-05
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    Rivastigmine

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    URL Supplier Web Content
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    USDMF

    Found USDMF

    29199
    Active
    RIVASTIGMINE USP
    2015-03-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-039 - Rev 00
    Valid
    Rivastigmine
    2020-11-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Rivastigmine (EP)
    2019-07-05
    Application Number
    29199
    R1-CEP 2015-039 - Rev 00
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    RIVASTIGMINE USP
    Rivastigmine
    Rivastigmine (EP)
    Issue/Submission Date
    2015-03-31
    2020-11-24
    2019-07-05
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    Rivastigmine Tartrate

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    USDMF

    Found USDMF

    21800
    Active
    RIVASTIGMINE TARTRATE USP
    2008-06-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-069 - Rev 00
    Valid
    Rivastigmine hydrogen tartrate
    2019-07-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Rivastigmine Hydrogen Tartrate (EP)...
    2019-07-05
    Application Number
    21800
    R1-CEP 2013-069 - Rev 00
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    RIVASTIGMINE TARTRATE USP
    Rivastigmine hydrogen tartrate
    Rivastigmine Hydrogen Tartrate (EP)...
    Issue/Submission Date
    2008-06-30
    2019-07-11
    2019-07-05
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    Teriflunomide

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    28898
    Active
    TERIFLUNOMIDE
    2016-03-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-264 - Rev 00
    Valid
    Teriflunomide
    2023-03-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081A4
    Expired
    Teriflunomide EP
    2021-09-17
    Application Number
    28898
    R0-CEP 2021-264 - Rev 00
    Indian CDSCO WC-0081A4
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TERIFLUNOMIDE
    Teriflunomide
    Teriflunomide EP
    Issue/Submission Date
    2016-03-16
    2023-03-09
    2021-09-17
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    Valsartan

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    21134
    Inactive
    Valsartan USP ( PROCESS I)
    2007-11-15
    CEP/COS

    Found CEP/COS

    CEP 2010-065 - Rev 07
    Valid
    Valsartan
    2023-10-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0083
    Valid
    Valsartan EP
    2022-06-03
    Application Number
    21134
    CEP 2010-065 - Rev 07
    Indian CDSCO WC-0083
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Valsartan USP ( PROCESS I)
    Valsartan
    Valsartan EP
    Issue/Submission Date
    2007-11-15
    2023-10-18
    2022-06-03
    ASK
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    Venlafaxine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    18734
    Active
    VENLAFAXINE HYDROCHLORIDE USP
    2005-09-09
    CEP/COS

    Found CEP/COS

    CEP 2006-225 - Rev 05
    Valid
    Venlafaxine hydrochloride
    2024-01-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0081
    Expired
    Venlafaxine Hydrochloride (EP)
    2019-07-05
    Application Number
    18734
    CEP 2006-225 - Rev 05
    Indian CDSCO WC-0081
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    VENLAFAXINE HYDROCHLORIDE USP
    Venlafaxine hydrochloride
    Venlafaxine Hydrochloride (EP)
    Issue/Submission Date
    2005-09-09
    2024-01-29
    2019-07-05
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