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

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    Cipla
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    India
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    Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra 400 013
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    +91 22 23082891 / 23095521
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    Amlodipine Besylate

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    USDMF

    Found USDMF

    17032
    Active
    AMLODIPINE BESYLATE USP
    2003-12-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-067 - Rev 01
    Valid
    Amlodipine besilate
    2014-07-28
    Japanese DMF

    Found JDMF

    221MF10131
    Amlodipine besylate at Cipla House,...
    2009-06-30
    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Amlodipine Besylate (EP)/USP/JP
    2022-06-20
    Application Number
    17032
    R1-CEP 2006-067 - Rev 01
    221MF10131
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-08
    Filing Details
    AMLODIPINE BESYLATE USP
    Amlodipine besilate
    Amlodipine besylate at Cipla House,...
    Amlodipine Besylate (EP)/USP/JP
    Issue/Submission Date
    2003-12-17
    2014-07-28
    2009-06-30
    2022-06-20
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    Celecoxib

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    USDMF

    Found USDMF

    16671
    Active
    CELECOXIB USP
    2003-06-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-186 - Rev 01
    Valid
    Celecoxib
    2023-05-30
    Japanese DMF

    Found JDMF

    230MF10110
    Celecoxib at Cipla House, Peninsula...
    2018-08-20
    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Celecoxib (BP/Ph. Eur./USP)
    2022-06-08
    Application Number
    16671
    R1-CEP 2014-186 - Rev 01
    230MF10110
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-09-08
    Filing Details
    CELECOXIB USP
    Celecoxib
    Celecoxib at Cipla House, Peninsula...
    Celecoxib (BP/Ph. Eur./USP)
    Issue/Submission Date
    2003-06-30
    2023-05-30
    2018-08-20
    2022-06-08
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    Etoposide

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    USDMF

    Found USDMF

    10642
    Active
    ETOPOSIDE USP
    1993-12-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-061 - Rev 05
    Valid
    Etoposide
    2020-04-28
    Japanese DMF

    Found JDMF

    222MF10214
    Etoposide at Cipla House, Peninsula...
    2010-08-05
    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Etoposide (USP/JP/BP/Ph.Eur)
    2022-06-20
    Application Number
    10642
    R1-CEP 2007-061 - Rev 05
    222MF10214
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    ETOPOSIDE USP
    Etoposide
    Etoposide at Cipla House, Peninsula...
    Etoposide (USP/JP/BP/Ph.Eur)
    Issue/Submission Date
    1993-12-30
    2020-04-28
    2010-08-05
    2022-06-20
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    Risedronate Sodium

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    USDMF

    Found USDMF

    20162
    Active
    RISEDRONATE SODIUM HEMI PENTAHYDRAT...
    2007-03-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-130 - Rev 00
    Valid
    Risedronate sodium 2.5-hydrate
    2020-04-28
    Japanese DMF

    Found JDMF

    223MF10141
    Sodium risedronate hydrate at Cipla...
    2011-09-07
    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Risedronate Sodium 2.5 Hydrate BP/E...
    2022-06-08
    Application Number
    20162
    R1-CEP 2014-130 - Rev 00
    223MF10141
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-09-08
    Filing Details
    RISEDRONATE SODIUM HEMI PENTAHYDRAT...
    Risedronate sodium 2.5-hydrate
    Sodium risedronate hydrate at Cipla...
    Risedronate Sodium 2.5 Hydrate BP/E...
    Issue/Submission Date
    2007-03-16
    2020-04-28
    2011-09-07
    2022-06-08
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    Abacavir Sulfate

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    USDMF

    Found USDMF

    26299
    Active
    ABACAVIR SULFATE USP
    2012-08-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-187 - Rev 00
    Valid
    Abacavir sulfate
    2021-01-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0140
    Valid
    Abacavir Sulphate (USP)
    2022-06-03
    Application Number
    26299
    R1-CEP 2014-187 - Rev 00
    Indian CDSCO WC-0140
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ABACAVIR SULFATE USP
    Abacavir sulfate
    Abacavir Sulphate (USP)
    Issue/Submission Date
    2012-08-22
    2021-01-20
    2022-06-03
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    Alendronate Sodium

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    USDMF

    Found USDMF

    14334
    Active
    ALENDRONATE SODIUM USP
    1999-08-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-126 - Rev 04
    Valid
    Sodium alendronate trihydrate
    2018-08-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Alendronate Sodium Trihydrate (USP/...
    2022-06-08
    Application Number
    14334
    R1-CEP 2005-126 - Rev 04
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-09-08
    Filing Details
    ALENDRONATE SODIUM USP
    Sodium alendronate trihydrate
    Alendronate Sodium Trihydrate (USP/...
    Issue/Submission Date
    1999-08-06
    2018-08-29
    2022-06-08
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    Anastrozole

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    USDMF

    Found USDMF

    19748
    Active
    ANASTROZOLE USP
    2008-02-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-021 - Rev 00
    Valid
    Anastrozole
    2021-02-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Anastrozole (USP)
    2022-06-20
    Application Number
    19748
    R1-CEP 2015-021 - Rev 00
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    ANASTROZOLE USP
    Anastrozole
    Anastrozole (USP)
    Issue/Submission Date
    2008-02-07
    2021-02-10
    2022-06-20
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    Bicalutamide

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    USDMF

    Found USDMF

    18723
    Active
    BICALUTAMIDE USP
    2005-08-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-191 - Rev 00
    Valid
    Bicalutamide
    2021-08-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Bicalutamide (USP/BP)
    2022-06-20
    Application Number
    18723
    R1-CEP 2014-191 - Rev 00
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    BICALUTAMIDE USP
    Bicalutamide
    Bicalutamide (USP/BP)
    Issue/Submission Date
    2005-08-31
    2021-08-03
    2022-06-20
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    Budesonide

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    USDMF

    Found USDMF

    27461
    Active
    BUDESONIDE USP
    2014-03-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-061 - Rev 02
    Valid
    Budesonide
    2022-09-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Budesonide (BP/Ph. Eur./USP)
    2022-06-08
    Application Number
    27461
    R1-CEP 2006-061 - Rev 02
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-09-08
    Filing Details
    BUDESONIDE USP
    Budesonide
    Budesonide (BP/Ph. Eur./USP)
    Issue/Submission Date
    2014-03-31
    2022-09-23
    2022-06-08
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    Carboplatin

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    USDMF

    Found USDMF

    16916
    Active
    CARBOPLATIN USP
    2003-10-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-125 - Rev 03
    Valid
    Carboplatin
    2019-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Carboplatin (BP)
    2022-06-20
    Application Number
    16916
    R1-CEP 2005-125 - Rev 03
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    CARBOPLATIN USP
    Carboplatin
    Carboplatin (BP)
    Issue/Submission Date
    2003-10-21
    2019-09-16
    2022-06-20
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    Cetirizine Dihydrochloride

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    USDMF

    Found USDMF

    15145
    Active
    CETIRIZINE DIHYDROCHLORIDE USP
    2000-11-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-081 - Rev 07
    Valid
    Cetirizine dihydrochloride
    2019-08-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0143
    Valid
    Cetirizine Hydrochloride (BP/Ph. Eu...
    2022-07-05
    Application Number
    15145
    R1-CEP 2000-081 - Rev 07
    Indian CDSCO WC-0143
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-09-08
    Filing Details
    CETIRIZINE DIHYDROCHLORIDE USP
    Cetirizine dihydrochloride
    Cetirizine Hydrochloride (BP/Ph. Eu...
    Issue/Submission Date
    2000-11-17
    2019-08-09
    2022-07-05
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    Efinaconazole

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    USDMF

    Found USDMF

    32317
    Active
    EFINACONAZOLE
    2018-02-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10122
    Efinaconazole at Cipla House, Penin...
    2020-10-05
    Written Confirmation

    Found WC

    Indian CDSCO WC-0142
    Valid
    Efinaconazole IH
    2022-06-17
    Application Number
    32317
    302MF10122
    Indian CDSCO WC-0142
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    EFINACONAZOLE
    Efinaconazole at Cipla House, Penin...
    Efinaconazole IH
    Issue/Submission Date
    2018-02-09
    2020-10-05
    2022-06-17
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    Escitalopram Oxalate

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    USDMF

    Found USDMF

    16636
    Active
    ESCITALOPRAM OXALATE USP
    2003-06-12
    CEP/COS

    Found CEP/COS

    CEP 2017-099 - Rev 01
    Valid
    Escitalopram oxalate
    2024-03-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0143
    Valid
    Escitalopram Oxalate (USP/IH)
    2022-07-05
    Application Number
    16636
    CEP 2017-099 - Rev 01
    Indian CDSCO WC-0143
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-09-08
    Filing Details
    ESCITALOPRAM OXALATE USP
    Escitalopram oxalate
    Escitalopram Oxalate (USP/IH)
    Issue/Submission Date
    2003-06-12
    2024-03-11
    2022-07-05
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    Esomeprazole Magnesium

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    USDMF

    Found USDMF

    18821
    Active
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE US...
    2005-09-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-320 - Rev 00
    Valid
    Esomeprazole magnesium trihydrate
    2022-08-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Esomeprazole Magnesium Dihydrate /t...
    2022-06-20
    Application Number
    18821
    R1-CEP 2015-320 - Rev 00
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-08
    Filing Details
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE US...
    Esomeprazole magnesium trihydrate
    Esomeprazole Magnesium Dihydrate /t...
    Issue/Submission Date
    2005-09-28
    2022-08-22
    2022-06-20
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    Exemestane

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22099
    Active
    EXEMESTANE USP
    2008-11-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-072 - Rev 00
    Valid
    Exemestane
    2022-08-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0140
    Valid
    Exemestane (IH)
    2022-06-03
    Application Number
    22099
    R1-CEP 2016-072 - Rev 00
    Indian CDSCO WC-0140
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    EXEMESTANE USP
    Exemestane
    Exemestane (IH)
    Issue/Submission Date
    2008-11-13
    2022-08-19
    2022-06-03
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    Felodipine

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    USDMF

    Found USDMF

    11449
    Active
    FELODIPINE USP
    1995-04-17
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-022 - Rev 05
    Valid
    Felodipine
    2023-04-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Felodipine (BP/USP)
    2022-06-20
    Application Number
    11449
    R1-CEP 1999-022 - Rev 05
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    FELODIPINE USP
    Felodipine
    Felodipine (BP/USP)
    Issue/Submission Date
    1995-04-17
    2023-04-06
    2022-06-20
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    Finasteride

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    USDMF

    Found USDMF

    15778
    Active
    FINASTERIDE USP
    2001-12-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-025 - Rev 05
    Valid
    Finasteride
    2022-04-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0143
    Valid
    Finasteride (USP/BP/PH. EUR)
    2022-07-05
    Application Number
    15778
    R1-CEP 2005-025 - Rev 05
    Indian CDSCO WC-0143
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-09-08
    Filing Details
    FINASTERIDE USP
    Finasteride
    Finasteride (USP/BP/PH. EUR)
    Issue/Submission Date
    2001-12-28
    2022-04-12
    2022-07-05
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    Fluticasone Propionate

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    USDMF

    Found USDMF

    15774
    Active
    FLUTICASONE PROPIONATE USP
    2001-12-19
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-075 - Rev 00
    Valid
    Fluticasone propionate, Modified Pr...
    2020-08-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Fluticasone Propinate (BP/Ph. Eur./...
    2022-06-08
    Application Number
    15774
    R0-CEP 2020-075 - Rev 00
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-09-08
    Filing Details
    FLUTICASONE PROPIONATE USP
    Fluticasone propionate, Modified Pr...
    Fluticasone Propinate (BP/Ph. Eur./...
    Issue/Submission Date
    2001-12-19
    2020-08-17
    2022-06-08
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    Formoterol Fumarate

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    USDMF

    Found USDMF

    20178
    Active
    FORMOTEROL FUMARATE USP
    2007-04-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-184 - Rev 03
    Valid
    Formoterol fumarate dihydrate
    2022-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Formoterol Fumarate Dihydrate (BP/P...
    2022-06-08
    Application Number
    20178
    R1-CEP 2005-184 - Rev 03
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-09-08
    Filing Details
    FORMOTEROL FUMARATE USP
    Formoterol fumarate dihydrate
    Formoterol Fumarate Dihydrate (BP/P...
    Issue/Submission Date
    2007-04-24
    2022-01-05
    2022-06-08
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    Granisetron Hydrochloride

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    USDMF

    Found USDMF

    17793
    Active
    GRANISETRON HYDROCHLORIDE USP
    2004-10-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-051 - Rev 02
    Valid
    Granisetron hydrochloride
    2019-12-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Granisetron Hydrochloride (Ph.Eur)
    2022-06-20
    Application Number
    17793
    R1-CEP 2007-051 - Rev 02
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    GRANISETRON HYDROCHLORIDE USP
    Granisetron hydrochloride
    Granisetron Hydrochloride (Ph.Eur)
    Issue/Submission Date
    2004-10-25
    2019-12-19
    2022-06-20
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    Imatinib Mesylate

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    USDMF

    Found USDMF

    26170
    Active
    IMATINIB MESYLATE (A-FORM)
    2013-01-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-230 - Rev 00
    Valid
    Imatinib mesilate, Alpha form
    2021-05-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Imatinib Mesylate Alpha Form /beta ...
    2022-06-20
    Application Number
    26170
    R1-CEP 2015-230 - Rev 00
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-08
    Filing Details
    IMATINIB MESYLATE (A-FORM)
    Imatinib mesilate, Alpha form
    Imatinib Mesylate Alpha Form /beta ...
    Issue/Submission Date
    2013-01-23
    2021-05-05
    2022-06-20
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    Lamivudine

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    USDMF

    Found USDMF

    17535
    Active
    LAMIVUDINE USP
    2004-07-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-103 - Rev 03
    Valid
    Lamivudine
    2018-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Lamivudine (BP/Ph. Eur./USP)
    2022-06-08
    Application Number
    17535
    R1-CEP 2007-103 - Rev 03
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-09-08
    Filing Details
    LAMIVUDINE USP
    Lamivudine
    Lamivudine (BP/Ph. Eur./USP)
    Issue/Submission Date
    2004-07-19
    2018-01-05
    2022-06-08
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    Lamotrigine

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    USDMF

    Found USDMF

    18421
    Active
    LAMOTRIGINE USP
    2005-06-09
    CEP/COS

    Found CEP/COS

    CEP 2010-212 - Rev 02
    Valid
    Lamotrigine
    2024-03-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Lamotrigine USP
    2022-06-20
    Application Number
    18421
    CEP 2010-212 - Rev 02
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    LAMOTRIGINE USP
    Lamotrigine
    Lamotrigine USP
    Issue/Submission Date
    2005-06-09
    2024-03-11
    2022-06-20
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    Leflunomide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16109
    Active
    LEFLUNOMIDE USP
    2002-08-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-050 - Rev 01
    Valid
    Leflunomide
    2014-07-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Leflunomide (USP/BP/Ph.Eur)
    2022-06-20
    Application Number
    16109
    R1-CEP 2007-050 - Rev 01
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-08
    Filing Details
    LEFLUNOMIDE USP
    Leflunomide
    Leflunomide (USP/BP/Ph.Eur)
    Issue/Submission Date
    2002-08-23
    2014-07-28
    2022-06-20
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    Letrozole

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    USDMF

    Found USDMF

    20175
    Active
    LETROZOLE USP
    2008-06-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-300 - Rev 00
    Valid
    Letrozole
    2019-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Letrozole (USP/BP/Ph.Eur)
    2022-06-20
    Application Number
    20175
    R1-CEP 2010-300 - Rev 00
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    LETROZOLE USP
    Letrozole
    Letrozole (USP/BP/Ph.Eur)
    Issue/Submission Date
    2008-06-26
    2019-07-08
    2022-06-20
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    Meloxicam

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    USDMF

    Found USDMF

    17148
    Active
    MELOXICAM USP
    2004-02-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-040 - Rev 05
    Valid
    Meloxicam, Micronised
    2022-11-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Meloxicam (BP/Ph. Eur./USP)
    2022-06-08
    Application Number
    17148
    R1-CEP 2009-040 - Rev 05
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-09-08
    Filing Details
    MELOXICAM USP
    Meloxicam, Micronised
    Meloxicam (BP/Ph. Eur./USP)
    Issue/Submission Date
    2004-02-06
    2022-11-04
    2022-06-08
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    Mometasone Furoate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20171
    Active
    MOMETHASONE FUROATE USP
    2007-12-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-112 - Rev 03
    Valid
    Mometasone furoate
    2019-08-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Mometasone Furoate (BP/Ph. Eur./USP...
    2022-06-08
    Application Number
    20171
    R1-CEP 2007-112 - Rev 03
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-09-08
    Filing Details
    MOMETHASONE FUROATE USP
    Mometasone furoate
    Mometasone Furoate (BP/Ph. Eur./USP...
    Issue/Submission Date
    2007-12-20
    2019-08-16
    2022-06-08
    ASK
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    Omeprazole

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    USDMF

    Found USDMF

    12827
    Active
    OMEPRAZOLE USP
    1998-01-21
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-122 - Rev 05
    Valid
    Omeprazole
    2015-03-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Omeprazole (BP/USP/Ph.Eur)
    2022-06-20
    Application Number
    12827
    R1-CEP 1997-122 - Rev 05
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    OMEPRAZOLE USP
    Omeprazole
    Omeprazole (BP/USP/Ph.Eur)
    Issue/Submission Date
    1998-01-21
    2015-03-19
    2022-06-20
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    Ondansetron Hydrochloride

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    USDMF

    Found USDMF

    15724
    Active
    ONDANSETRON HCL USP
    2001-11-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-279 - Rev 03
    Valid
    Ondansetron hydrochloride dihydrate
    2014-07-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Ondansetron HCI (BP/Ph. Eur./USP)
    2022-06-08
    Application Number
    15724
    R1-CEP 2006-279 - Rev 03
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-09-08
    Filing Details
    ONDANSETRON HCL USP
    Ondansetron hydrochloride dihydrate
    Ondansetron HCI (BP/Ph. Eur./USP)
    Issue/Submission Date
    2001-11-15
    2014-07-28
    2022-06-08
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    Oseltamivir Phosphate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21557
    Active
    OSELTAMIVIR PHOSPHATE USP
    2008-05-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10109
    Oseltamivir Phosphate at Cipla Hous...
    2022-08-03
    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Oseltamivir Phosphate (BP/Ph. Eur./...
    2022-06-08
    Application Number
    21557
    304MF10109
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-09-08
    Filing Details
    OSELTAMIVIR PHOSPHATE USP
    Oseltamivir Phosphate at Cipla Hous...
    Oseltamivir Phosphate (BP/Ph. Eur./...
    Issue/Submission Date
    2008-05-29
    2022-08-03
    2022-06-08
    ASK
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    • FDA
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    Pantoprazole Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17720
    Active
    PANTOPRAZOLE SODIUM USP
    2004-09-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-218 - Rev 01
    Valid
    Pantoprazole sodium sesquihydrate
    2017-01-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Pantoprazole Sodium USP/Pantoprazol...
    2022-06-20
    Application Number
    17720
    R1-CEP 2008-218 - Rev 01
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-08
    Filing Details
    PANTOPRAZOLE SODIUM USP
    Pantoprazole sodium sesquihydrate
    Pantoprazole Sodium USP/Pantoprazol...
    Issue/Submission Date
    2004-09-30
    2017-01-06
    2022-06-20
    ASK
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    your Marketing & Sales content
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    • FDA
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    Pirfenidone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    32423
    Active
    PIRFENIDONE
    2018-03-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-096 - Rev 00
    Valid
    Pirfenidone
    2020-10-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0142
    Valid
    Pirfenidone (IH)
    2022-06-17
    Application Number
    32423
    R0-CEP 2018-096 - Rev 00
    Indian CDSCO WC-0142
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-04
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Pirfenidone (IH)
    Issue/Submission Date
    2018-03-22
    2020-10-05
    2022-06-17
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    your Marketing & Sales content
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    Pramipexole Dihydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    18701
    Active
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    2005-08-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-047 - Rev 02
    Valid
    Pramipexole dihydrochloride monohyd...
    2021-08-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Pramipexole Dihydrochloride Monohyd...
    2022-06-08
    Application Number
    18701
    R1-CEP 2011-047 - Rev 02
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-09-08
    Filing Details
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    Pramipexole dihydrochloride monohyd...
    Pramipexole Dihydrochloride Monohyd...
    Issue/Submission Date
    2005-08-25
    2021-08-16
    2022-06-08
    ASK
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    your Marketing & Sales content
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    • FDA
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    Praziquantel

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    14352
    Active
    PRAZIQUANTEL USP
    1999-08-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-081 - Rev 03
    Valid
    Praziquantel
    2017-05-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0143
    Valid
    Praziquantel (BP/Ph. Eur./USP)
    2022-07-05
    Application Number
    14352
    R1-CEP 2007-081 - Rev 03
    Indian CDSCO WC-0143
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-09-08
    Filing Details
    PRAZIQUANTEL USP
    Praziquantel
    Praziquantel (BP/Ph. Eur./USP)
    Issue/Submission Date
    1999-08-19
    2017-05-22
    2022-07-05
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    Ramipril

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17033
    Active
    RAMIPRIL USP
    2003-12-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-024 - Rev 03
    Valid
    Ramipril
    2019-10-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Ramipril (BP/Ph. Eur./USP)
    2022-06-08
    Application Number
    17033
    R1-CEP 2007-024 - Rev 03
    Indian CDSCO WC-0144
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-09-08
    Filing Details
    RAMIPRIL USP
    Ramipril
    Ramipril (BP/Ph. Eur./USP)
    Issue/Submission Date
    2003-12-17
    2019-10-09
    2022-06-08
    ASK
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    Risperidone

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    16963
    Active
    RISPERIDONE USP
    2003-11-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-037 - Rev 02
    Valid
    Risperidone
    2014-07-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Risperidone (USP/BP/Ph.Eur)
    2022-06-20
    Application Number
    16963
    R1-CEP 2005-037 - Rev 02
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-08
    Filing Details
    RISPERIDONE USP
    Risperidone
    Risperidone (USP/BP/Ph.Eur)
    Issue/Submission Date
    2003-11-17
    2014-07-28
    2022-06-20
    ASK
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    • FDA
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    Rivastigmine Tartrate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    17064
    Active
    RIVASTIGMINE TARTRATE USP
    2003-12-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-053 - Rev 00
    Valid
    Rivastigmine hydrogen tartrate
    2021-10-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0142
    Valid
    Rivastigmine Hydrogen Tartrate (Ph....
    2022-06-17
    Application Number
    17064
    R1-CEP 2014-053 - Rev 00
    Indian CDSCO WC-0142
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-04
    Filing Details
    RIVASTIGMINE TARTRATE USP
    Rivastigmine hydrogen tartrate
    Rivastigmine Hydrogen Tartrate (Ph....
    Issue/Submission Date
    2003-12-29
    2021-10-25
    2022-06-17
    ASK
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    • FDA
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    Salbutamol Sulphate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    6885
    Active
    ALBUTEROL SULFATE USP
    1987-01-20
    CEP/COS

    Found CEP/COS

    CEP 2005-080 - Rev 06
    Valid
    Salbutamol sulfate
    2024-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0142
    Valid
    Salbutamol /Levosalbutamol Sulphate...
    2022-06-17
    Application Number
    6885
    CEP 2005-080 - Rev 06
    Indian CDSCO WC-0142
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-04
    Filing Details
    ALBUTEROL SULFATE USP
    Salbutamol sulfate
    Salbutamol /Levosalbutamol Sulphate...
    Issue/Submission Date
    1987-01-20
    2024-03-07
    2022-06-17
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    Solifenacin Succinate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29489
    Active
    SOLIFENACIN SUCCINATE
    2015-11-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-062 - Rev 00
    Valid
    Solifenacin succinate
    2023-08-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0142
    Valid
    Solifenacin Succinate IH
    2022-06-17
    Application Number
    29489
    R1-CEP 2017-062 - Rev 00
    Indian CDSCO WC-0142
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-04
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin succinate
    Solifenacin Succinate IH
    Issue/Submission Date
    2015-11-02
    2023-08-16
    2022-06-17
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    Terbinafine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17330
    Active
    TERBINAFINE HYDROCHLORIDE USP
    2004-04-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-028 - Rev 04
    Valid
    Terbinafine hydrochloride
    2021-01-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0140
    Valid
    Terbinafine Hydrochloride (BP/Ph. E...
    2022-06-03
    Application Number
    17330
    R1-CEP 2007-028 - Rev 04
    Indian CDSCO WC-0140
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    TERBINAFINE HYDROCHLORIDE USP
    Terbinafine hydrochloride
    Terbinafine Hydrochloride (BP/Ph. E...
    Issue/Submission Date
    2004-04-22
    2021-01-18
    2022-06-03
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    Carvedilol

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    URL Supplier Web Content
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    USDMF

    Caution USDMF

    17187
    Inactive
    CARVEDILOL USP
    2004-02-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-124 - Rev 03
    Valid
    Carvedilol
    2018-03-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Carvedilol (BP/Ph. Eur./USP)
    2022-06-08
    Application Number
    17187
    R1-CEP 2005-124 - Rev 03
    Indian CDSCO WC-0144
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-09-08
    Filing Details
    CARVEDILOL USP
    Carvedilol
    Carvedilol (BP/Ph. Eur./USP)
    Issue/Submission Date
    2004-02-25
    2018-03-09
    2022-06-08
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    Citalopram Hydrobromide

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    USDMF

    Caution USDMF

    15813
    Inactive
    CITALOPRAM HYDROBROMIDE
    2002-01-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-012 - Rev 01
    Valid
    Citalopram hydrobromide
    2018-02-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Citalopram Hydrobromide (BP/Ph. Eur...
    2022-06-08
    Application Number
    15813
    R1-CEP 2009-012 - Rev 01
    Indian CDSCO WC-0144
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-09-08
    Filing Details
    CITALOPRAM HYDROBROMIDE
    Citalopram hydrobromide
    Citalopram Hydrobromide (BP/Ph. Eur...
    Issue/Submission Date
    2002-01-17
    2018-02-08
    2022-06-08
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    Esomeprazole Magnesium

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    USDMF

    Found USDMF

    29639
    Active
    ESOMEPRAZOLE MAGNESIUM USP
    2015-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-077 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate, M...
    2021-08-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0141
    Expired
    Esomeprazole Magnesium Dihydrate
    2019-06-26
    Application Number
    29639
    R1-CEP 2014-077 - Rev 00
    Indian CDSCO WC-0141
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2019-07-07
    Filing Details
    ESOMEPRAZOLE MAGNESIUM USP
    Esomeprazole magnesium dihydrate, M...
    Esomeprazole Magnesium Dihydrate
    Issue/Submission Date
    2015-09-01
    2021-08-26
    2019-06-26
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    Fluconazole

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    USDMF

    Caution USDMF

    11524
    Inactive
    FLUCONAZOLE USP
    1995-05-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-141 - Rev 01
    Valid
    Fluconazole
    2018-01-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0144
    Valid
    Fluconazole (BP/Ph.Eur/USP)
    2022-06-08
    Application Number
    11524
    R1-CEP 2007-141 - Rev 01
    Indian CDSCO WC-0144
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-09-08
    Filing Details
    FLUCONAZOLE USP
    Fluconazole
    Fluconazole (BP/Ph.Eur/USP)
    Issue/Submission Date
    1995-05-24
    2018-01-04
    2022-06-08
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    Gefitinib

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    USDMF

    Found USDMF

    29090
    Active
    GEFITINIB
    2015-03-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-002 - Rev 00
    Valid
    Gefitinib
    2023-03-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0138
    Expired
    Gefitinib (IH)
    2019-08-09
    Application Number
    29090
    R1-CEP 2017-002 - Rev 00
    Indian CDSCO WC-0138
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-08
    Filing Details
    GEFITINIB
    Gefitinib
    Gefitinib (IH)
    Issue/Submission Date
    2015-03-23
    2023-03-24
    2019-08-09
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    Lopinavir

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    USDMF

    Found USDMF

    27462
    Active
    LOPINAVIR USP
    2013-09-27
    CEP/COS

    Caution CEP/COS

    R0-CEP 2015-306 - Rev 00
    Withdrawn by Holder
    Lopinavir
    2018-02-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Lopinavir (USP)
    2022-06-20
    Application Number
    27462
    R0-CEP 2015-306 - Rev 00
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Valid
    2025-08-08
    Filing Details
    LOPINAVIR USP
    Lopinavir
    Lopinavir (USP)
    Issue/Submission Date
    2013-09-27
    2018-02-28
    2022-06-20
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    Nevirapine

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    USDMF

    Found USDMF

    17905
    Active
    NEVIRAPINE USP
    2004-12-17
    CEP/COS

    Caution CEP/COS

    R1-CEP 2007-087 - Rev 02
    Withdrawn by Holder
    Nevirapine, 017905
    2016-05-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0140
    Valid
    Anhydrous Nevirapine (BP/Ph. Eur.)
    2022-06-03
    Application Number
    17905
    R1-CEP 2007-087 - Rev 02
    Indian CDSCO WC-0140
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Valid
    2025-07-02
    Filing Details
    NEVIRAPINE USP
    Nevirapine, 017905
    Anhydrous Nevirapine (BP/Ph. Eur.)
    Issue/Submission Date
    2004-12-17
    2016-05-18
    2022-06-03
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    Salmeterol Xinafoate

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    USDMF

    Caution USDMF

    15706
    Inactive
    SALMETEROL XINAFOATE
    2001-11-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-296 - Rev 05
    Valid
    Salmeterol xinafoate, Micronised, g...
    2022-04-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0142
    Valid
    Salmeterol Xinafoate (Ph. Eur./BP/U...
    2022-06-17
    Application Number
    15706
    R1-CEP 2006-296 - Rev 05
    Indian CDSCO WC-0142
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-04
    Filing Details
    SALMETEROL XINAFOATE
    Salmeterol xinafoate, Micronised, g...
    Salmeterol Xinafoate (Ph. Eur./BP/U...
    Issue/Submission Date
    2001-11-08
    2022-04-12
    2022-06-17
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    Trimetazidine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20680
    Active
    TRIMETAZIDINE DIHYDROCHLORIDE BP/PH...
    2007-08-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-231 - Rev 03
    Valid
    Trimetazidine dihydrochloride
    2022-10-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0141
    Expired
    Trimetazidine Dihydrochloride (B.P....
    2019-06-26
    Application Number
    20680
    R1-CEP 2007-231 - Rev 03
    Indian CDSCO WC-0141
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2019-07-07
    Filing Details
    TRIMETAZIDINE DIHYDROCHLORIDE BP/PH...
    Trimetazidine dihydrochloride
    Trimetazidine Dihydrochloride (B.P....
    Issue/Submission Date
    2007-08-16
    2022-10-17
    2019-06-26
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    Zidovudine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16677
    Active
    ZIDOVUDINE USP
    2003-06-30
    CEP/COS

    Caution CEP/COS

    R1-CEP 2008-125 - Rev 00
    Withdrawn by Holder
    Zidovudine
    2018-05-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0113
    Valid
    Zidovudine (Ph.Eur)
    2022-06-20
    Application Number
    16677
    R1-CEP 2008-125 - Rev 00
    Indian CDSCO WC-0113
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Valid
    2025-08-08
    Filing Details
    ZIDOVUDINE USP
    Zidovudine
    Zidovudine (Ph.Eur)
    Issue/Submission Date
    2003-06-30
    2018-05-02
    2022-06-20
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