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

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    Amoli Organics
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    Country
    Country
    India
    Address
    Address
    407, Dalamal House, Jamnalal Bajaj Road, Nariman Point, Mumbai - 400 021, Maharashtra
    Telephone
    Telephone
    +91-22-6621 4715
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    Email
    enquiries@pharmacompass.com
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    https://www.amoliindia.com/
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    Carbamazepine

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    USDMF

    Found USDMF

    23170
    Active
    CARBAMAZEPINE USP
    2009-10-14
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-102 - Rev 07
    Valid
    Carbamazepine
    2021-07-22
    Japanese DMF

    Found JDMF

    230MF10157
    Carbamazepine at Block No. 422, ECP...
    2018-11-16
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Carbamazepine (BP/USP/EP)
    2019-08-13
    Application Number
    23170
    R1-CEP 1997-102 - Rev 07
    230MF10157
    Indian CDSCO WC-0077
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-12
    Filing Details
    CARBAMAZEPINE USP
    Carbamazepine
    Carbamazepine at Block No. 422, ECP...
    Carbamazepine (BP/USP/EP)
    Issue/Submission Date
    2009-10-14
    2021-07-22
    2018-11-16
    2019-08-13
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    Atorvastatin

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    USDMF

    Found USDMF

    25346
    Active
    ATORVASTATIN CALCIUM USP
    2011-11-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-206 - Rev 02
    Valid
    Atorvastatin calcium
    2023-03-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0077A5-6
    Valid
    Atorvastatin Calcium Trihydrate IP/...
    2022-06-24
    Application Number
    25346
    R1-CEP 2014-206 - Rev 02
    Indian CDSCO WC-0077A5-6
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-12
    Filing Details
    ATORVASTATIN CALCIUM USP
    Atorvastatin calcium
    Atorvastatin Calcium Trihydrate IP/...
    Issue/Submission Date
    2011-11-04
    2023-03-23
    2022-06-24
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    Diclofenac Sodium

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    USDMF

    Caution USDMF

    11676
    Inactive
    DICLOFENAC SODIUM
    1995-09-26
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-066 - Rev 04
    Valid
    Diclofenac sodium
    2021-06-01
    Japanese DMF

    Found JDMF

    218MF10010
    "Japan-station" diclofenac sodium (...
    2006-01-27
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0134
    Expired
    Diclofenac Sodium (BP/EP/USP)
    2016-06-23
    Application Number
    11676
    R1-CEP 1997-066 - Rev 04
    218MF10010
    Indian CDSCO WC-0134
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2019-07-02
    Filing Details
    DICLOFENAC SODIUM
    Diclofenac sodium
    "Japan-station" diclofenac sodium (...
    Diclofenac Sodium (BP/EP/USP)
    Issue/Submission Date
    1995-09-26
    2021-06-01
    2006-01-27
    2016-06-23
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    Tadalafil

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    USDMF

    Found USDMF

    30608
    Active
    TADALAFIL USP
    2016-06-10
    CEP/COS

    Found CEP/COS

    CEP 2016-183 - Rev 01
    Valid
    Tadalafil
    2024-01-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0077A8
    Valid
    Tadalafil EP/BP/USP
    2022-06-29
    Application Number
    30608
    CEP 2016-183 - Rev 01
    Indian CDSCO WC-0077A8
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-12
    Filing Details
    TADALAFIL USP
    Tadalafil
    Tadalafil EP/BP/USP
    Issue/Submission Date
    2016-06-10
    2024-01-11
    2022-06-29
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    Venlafaxine Hydrochloride

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    USDMF

    Found USDMF

    21439
    Active
    VENLAFAXINE HYDROCHLORIDE USP
    2008-03-14
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-322 - Rev 00
    Valid
    Venlafaxine hydrochloride, Form-B
    2021-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0077A5-6
    Valid
    Venlafaxine HCl EP/BP/USP
    2022-06-24
    Application Number
    21439
    R0-CEP 2021-322 - Rev 00
    Indian CDSCO WC-0077A5-6
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-12
    Filing Details
    VENLAFAXINE HYDROCHLORIDE USP
    Venlafaxine hydrochloride, Form-B
    Venlafaxine HCl EP/BP/USP
    Issue/Submission Date
    2008-03-14
    2021-12-20
    2022-06-24
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    Celecoxib

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    USDMF

    Found USDMF

    25427
    Active
    CELECOXIB USP
    2012-01-03
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-114 - Rev 00
    Valid
    Celecoxib, Process-II
    2022-06-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Celecoxib (IH)
    2019-08-13
    Application Number
    25427
    R0-CEP 2022-114 - Rev 00
    Indian CDSCO WC-0077
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-12
    Filing Details
    CELECOXIB USP
    Celecoxib, Process-II
    Celecoxib (IH)
    Issue/Submission Date
    2012-01-03
    2022-06-16
    2019-08-13
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    Clotrimazole

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    USDMF

    Found USDMF

    26483
    Active
    CLOTRIMAZOLE USP
    2012-10-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-009 - Rev 01
    Valid
    Clotrimazole
    2019-10-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0134
    Expired
    Clotrimazole (BP/EP/USP)
    2016-06-23
    Application Number
    26483
    R1-CEP 2000-009 - Rev 01
    Indian CDSCO WC-0134
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2019-07-02
    Filing Details
    CLOTRIMAZOLE USP
    Clotrimazole
    Clotrimazole (BP/EP/USP)
    Issue/Submission Date
    2012-10-12
    2019-10-07
    2016-06-23
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    Diclofenac Potassium

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    USDMF

    Found USDMF

    23028
    Active
    DICLOFENAC POTASSIUM USP
    2009-08-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-144 - Rev 01
    Valid
    Diclofenac potassium
    2022-06-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0134
    Expired
    Diclofenac Potassium (BP/EP/USP)
    2016-06-23
    Application Number
    23028
    R1-CEP 2007-144 - Rev 01
    Indian CDSCO WC-0134
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2019-07-02
    Filing Details
    DICLOFENAC POTASSIUM USP
    Diclofenac potassium
    Diclofenac Potassium (BP/EP/USP)
    Issue/Submission Date
    2009-08-12
    2022-06-17
    2016-06-23
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    Hydrochlorothiazide

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    USDMF

    Found USDMF

    25849
    Active
    HYDROCHLOROTHIAZIDE USP
    2012-03-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-012 - Rev 00
    Valid
    Hydrochlorothiazide
    2022-07-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077A3
    Expired
    Hydrochlorothiazide JP
    2020-03-09
    Application Number
    25849
    R1-CEP 2016-012 - Rev 00
    Indian CDSCO WC-0077A3
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-12
    Filing Details
    HYDROCHLOROTHIAZIDE USP
    Hydrochlorothiazide
    Hydrochlorothiazide JP
    Issue/Submission Date
    2012-03-13
    2022-07-28
    2020-03-09
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    Olmesartan Medoxomil

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    USDMF

    Found USDMF

    27164
    Active
    OLMESARTAN MEDOXOMIL USP
    2013-05-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-404 - Rev 01
    Valid
    Olmesartan medoxomil, Process – I...
    2023-02-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Olmesartan Medoxomil EP/USP
    2019-08-13
    Application Number
    27164
    R0-CEP 2021-404 - Rev 01
    Indian CDSCO WC-0077
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-12
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Olmesartan medoxomil, Process – I...
    Olmesartan Medoxomil EP/USP
    Issue/Submission Date
    2013-05-21
    2023-02-22
    2019-08-13
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    Oxcarbazepine

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    USDMF

    Found USDMF

    23191
    Active
    OXCARBAZEPINE USP
    2009-10-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-211 - Rev 00
    Valid
    Oxcarbazepine
    2022-10-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Oxcarbazepine (USP)
    2019-08-13
    Application Number
    23191
    R1-CEP 2016-211 - Rev 00
    Indian CDSCO WC-0077
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-12
    Filing Details
    OXCARBAZEPINE USP
    Oxcarbazepine
    Oxcarbazepine (USP)
    Issue/Submission Date
    2009-10-20
    2022-10-25
    2019-08-13
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    Pirfenidone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33599
    Active
    PIRFENIDONE
    2019-02-19
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-067 - Rev 00
    Valid
    Pirfenidone
    2020-06-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077A3
    Expired
    Pirfenidone EP
    2020-03-09
    Application Number
    33599
    R0-CEP 2019-067 - Rev 00
    Indian CDSCO WC-0077A3
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-12
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Pirfenidone EP
    Issue/Submission Date
    2019-02-19
    2020-06-08
    2020-03-09
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    Sertraline Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36258
    Active
    SERTRALINE HYDROCHLORIDE USP
    2021-10-15
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-424 - Rev 00
    Valid
    Sertraline hydrochloride
    2023-06-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Sertraline HCL (IH)
    2019-08-13
    Application Number
    36258
    R0-CEP 2021-424 - Rev 00
    Indian CDSCO WC-0077
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-12
    Filing Details
    SERTRALINE HYDROCHLORIDE USP
    Sertraline hydrochloride
    Sertraline HCL (IH)
    Issue/Submission Date
    2021-10-15
    2023-06-19
    2019-08-13
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    Solifenacin Succinate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31789
    Active
    SOLIFENACIN SUCCINATE
    2017-08-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-200 - Rev 00
    Valid
    Solifenacin succinate
    2023-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077A3
    Expired
    Solifenacin Succinate EP
    2020-03-09
    Application Number
    31789
    R1-CEP 2017-200 - Rev 00
    Indian CDSCO WC-0077A3
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-12
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin succinate
    Solifenacin Succinate EP
    Issue/Submission Date
    2017-08-03
    2023-07-07
    2020-03-09
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    Venlafaxine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36140
    Active
    VENLAFAXINE HYDROCHLORIDE (FORM-B)
    2021-07-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-092 - Rev 01
    Valid
    Venlafaxine hydrochloride
    2019-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Venlafaxine HCL (EP)
    2019-08-13
    Application Number
    36140
    R1-CEP 2008-092 - Rev 01
    Indian CDSCO WC-0077
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-12
    Filing Details
    VENLAFAXINE HYDROCHLORIDE (FORM-B)
    Venlafaxine hydrochloride
    Venlafaxine HCL (EP)
    Issue/Submission Date
    2021-07-29
    2019-12-06
    2019-08-13
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    Ascorbic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26596
    Active
    ASCORBIC ACID USP
    2012-11-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0077n
    Valid
    ASCORBIC ACID USP/IP/BP/EP
    2022-06-09
    Application Number
    26596
    Indian CDSCO WC-0077n
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-08-12
    Filing Details
    ASCORBIC ACID USP
    ASCORBIC ACID USP/IP/BP/EP
    Issue/Submission Date
    2012-11-05
    2022-06-09
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    Deferasirox

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35651
    Active
    DEFERASIROX
    2021-03-11
    CEP/COS

    Found CEP/COS

    CEP 2021-176 - Rev 00
    Valid
    Deferasirox
    2023-10-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35651
    CEP 2021-176 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DEFERASIROX
    Deferasirox
    Issue/Submission Date
    2021-03-11
    2023-10-23
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    Levetiracetam

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23585
    Inactive
    LEVETIRACETAM
    2010-03-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-270 - Rev 00
    Valid
    Levetiracetam
    2021-09-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Levetiracetam (EP)
    2019-08-13
    Application Number
    23585
    R1-CEP 2014-270 - Rev 00
    Indian CDSCO WC-0077
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-12
    Filing Details
    LEVETIRACETAM
    Levetiracetam
    Levetiracetam (EP)
    Issue/Submission Date
    2010-03-02
    2021-09-09
    2019-08-13
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    Mesalazine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34792
    Active
    MESALAMINE
    2020-04-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-167 - Rev 00
    Valid
    Mesalazine
    2021-11-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34792
    R0-CEP 2020-167 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MESALAMINE
    Mesalazine
    Issue/Submission Date
    2020-04-30
    2021-11-24
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    Ranolazine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33001
    Active
    RANOLAZINE
    2018-07-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0077A2
    Valid
    Ranolazine IH
    2022-06-15
    Application Number
    33001
    Indian CDSCO WC-0077A2
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-12
    Filing Details
    RANOLAZINE
    Ranolazine IH
    Issue/Submission Date
    2018-07-30
    2022-06-15
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    Rosuvastatin Calcium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    28659
    Inactive
    ROSUVASTATIN CALCIUM
    2014-10-07
    CEP/COS

    Found CEP/COS

    CEP 2018-108 - Rev 04
    Valid
    Rosuvastatin calcium
    2023-10-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077A3
    Expired
    Rosuvastatin Calcium USP
    2020-03-09
    Application Number
    28659
    CEP 2018-108 - Rev 04
    Indian CDSCO WC-0077A3
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-12
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin calcium
    Rosuvastatin Calcium USP
    Issue/Submission Date
    2014-10-07
    2023-10-12
    2020-03-09
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    Sildenafil Citrate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25231
    Inactive
    SILDENAFIL CITRATE FORM-II
    2011-11-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-223 - Rev 01
    Valid
    Sildenafil citrate
    2021-02-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Sildenafil Citrate (IH
    2019-08-13
    Application Number
    25231
    R1-CEP 2014-223 - Rev 01
    Indian CDSCO WC-0077
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-12
    Filing Details
    SILDENAFIL CITRATE FORM-II
    Sildenafil citrate
    Sildenafil Citrate (IH
    Issue/Submission Date
    2011-11-02
    2021-02-04
    2019-08-13
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    Aceclofenac

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-100 - Rev 00
    Valid
    Aceclofenac
    2021-02-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0134
    Expired
    Aceclofenac (BP/EP)
    2016-06-23
    Application Number
    R1-CEP 2014-100 - Rev 00
    Indian CDSCO WC-0134
    Status
    Valid
     
    Expired
    2019-07-02
    Filing Details
    Aceclofenac
    Aceclofenac (BP/EP)
    Issue/Submission Date
    2021-02-10
    2016-06-23
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    Diclofenac

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23680
    Active
    DICLOFENAC DIETHYLAMINE
    2010-03-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0134
    Expired
    Diclofenac Free Acid
    2016-06-23
    Application Number
    23680
    Indian CDSCO WC-0134
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2019-07-02
    Filing Details
    DICLOFENAC DIETHYLAMINE
    Diclofenac Free Acid
    Issue/Submission Date
    2010-03-21
    2016-06-23
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    Dihydralazine Sulfate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-027 - Rev 00
    Valid
    Dihydralazine sulfate, hydrated
    2021-06-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0134
    Expired
    Hydrated Dihydralazine Sulphate (BP...
    2016-06-23
    Application Number
    R1-CEP 2015-027 - Rev 00
    Indian CDSCO WC-0134
    Status
    Valid
     
    Expired
    2019-07-02
    Filing Details
    Dihydralazine sulfate, hydrated
    Hydrated Dihydralazine Sulphate (BP...
    Issue/Submission Date
    2021-06-30
    2016-06-23
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    Dimethyl Fumarate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34082
    Active
    DIMETHYL FUMARATE
    2019-09-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077A4
    Expired
    Dimethyl Fumarate IH
    2020-03-18
    Application Number
    34082
    Indian CDSCO WC-0077A4
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-08-12
    Filing Details
    DIMETHYL FUMARATE
    Dimethyl Fumarate IH
    Issue/Submission Date
    2019-09-05
    2020-03-18
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    Linezolid

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    27534
    Inactive
    LINEZOLID [FORM-1]
    2013-09-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0077A5-6
    Valid
    Linezolid IH
    2022-06-24
    Application Number
    27534
    Indian CDSCO WC-0077A5-6
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-08-12
    Filing Details
    LINEZOLID [FORM-1]
    Linezolid IH
    Issue/Submission Date
    2013-09-13
    2022-06-24
    ASK
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    Rosuvastatin Calcium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    32794
    Active
    ROSUVASTATIN CALCIUM
    2018-05-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Rosuvastatin Calcium IP/EP
    2019-08-13
    Application Number
    32794
    Indian CDSCO WC-0077
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-12
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin Calcium IP/EP
    Issue/Submission Date
    2018-05-17
    2019-08-13
    ASK
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    Aceclofenac

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-419 - Rev 00
    Valid
    Aceclofenac, Process-II
    2022-12-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-419 - Rev 00
    Status
    Valid
     
    Filing Details
    Aceclofenac, Process-II
    Issue/Submission Date
    2022-12-09
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    • FDA
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    Apixaban

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    38900
    Active
    APIXABAN
    2023-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38900
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APIXABAN
    Issue/Submission Date
    2023-09-23
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    Aripiprazole

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    29138
    Inactive
    ARIPIPRAZOLE USP
    2015-03-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Aripiprazole USP
    2019-08-13
    Application Number
    29138
    Indian CDSCO WC-0077
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-08-12
    Filing Details
    ARIPIPRAZOLE USP
    Aripiprazole USP
    Issue/Submission Date
    2015-03-24
    2019-08-13
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    • FDA
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    Carbamazepine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2021-129 - Rev 01
    Valid
    Carbamazepine, Process II
    2023-10-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2021-129 - Rev 01
    Status
    Valid
     
    Filing Details
    Carbamazepine, Process II
    Issue/Submission Date
    2023-10-26
    ASK
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    • FDA
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    Celecoxib

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-184 - Rev 00
    Valid
    Celecoxib
    2020-08-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2014-184 - Rev 00
    Status
    Valid
     
    Filing Details
    Celecoxib
    Issue/Submission Date
    2020-08-28
    ASK
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    • FDA
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    Chlorthalidone

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

    See Less

    USDMF

    Found USDMF

    30551
    Active
    CHLORTHALIDONE USP
    2016-05-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30551
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CHLORTHALIDONE USP
    Issue/Submission Date
    2016-05-24
    ASK
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    Chlorthalidone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    26648
    Inactive
    CHLORTHALIDONE USP
    2012-11-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Chlorthalidone EP/USP/IP
    2019-08-13
    Application Number
    26648
    Indian CDSCO WC-0077
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-08-12
    Filing Details
    CHLORTHALIDONE USP
    Chlorthalidone EP/USP/IP
    Issue/Submission Date
    2012-11-29
    2019-08-13
    ASK
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    • FDA
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    Desvenlafaxine Succinate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    37036
    Active
    DESVENLAFAXINE SUCCINATE MONOHYDRAT...
    2022-04-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37036
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DESVENLAFAXINE SUCCINATE MONOHYDRAT...
    Issue/Submission Date
    2022-04-14
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    Diclofenac

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

    See Less

    USDMF

    Found USDMF

    28208
    Active
    DICLOFENAC
    2014-04-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28208
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DICLOFENAC
    Issue/Submission Date
    2014-04-18
    ASK
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    • FDA
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    Diclofenac Epolamine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25224
    Active
    DICLOFENAC EPOLAMINE
    2011-09-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25224
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DICLOFENAC EPOLAMINE
    Issue/Submission Date
    2011-09-16
    ASK
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    Diclofenac Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    20849
    Active
    DICLOFENAC SODIUM USP
    2007-09-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20849
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DICLOFENAC SODIUM USP
    Issue/Submission Date
    2007-09-13
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    • FDA
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    Dihydralazine Mesylate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0077A5-6
    Valid
    Dihydralazine Mesylate IH
    2022-06-24
    Application Number
    Indian CDSCO WC-0077A5-6
    Status
     
    Valid
    2025-08-12
    Filing Details
    Dihydralazine Mesylate IH
    Issue/Submission Date
    2022-06-24
    ASK
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    your Marketing & Sales content
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    • FDA
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    Levetiracetam

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25762
    Active
    LEVETIRACETAM USP [ROUTE CODE - LVS...
    2012-02-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25762
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LEVETIRACETAM USP [ROUTE CODE - LVS...
    Issue/Submission Date
    2012-02-08
    ASK
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    Linezolid

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

    See Less

    USDMF

    Caution USDMF

    27673
    Inactive
    LINEZOLID [FORM-II]
    2013-11-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0077
    Expired
    Linezolid IH
    2019-08-13
    Application Number
    27673
    Indian CDSCO WC-0077
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-08-12
    Filing Details
    LINEZOLID [FORM-II]
    Linezolid IH
    Issue/Submission Date
    2013-11-12
    2019-08-13
    ASK
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    your Marketing & Sales content
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    • FDA
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    Mirabegron

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    38825
    Active
    MIRABEGRON
    2023-09-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38825
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MIRABEGRON
    Issue/Submission Date
    2023-09-15
    ASK
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    • FDA
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    Olmesartan Medoxomil

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-339 - Rev 00
    Valid
    Olmesartan medoxomil
    2022-04-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-339 - Rev 00
    Status
    Valid
     
    Filing Details
    Olmesartan medoxomil
    Issue/Submission Date
    2022-04-14
    ASK
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    • FDA
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    Rivaroxaban

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

    See Less

    USDMF

    Found USDMF

    38122
    Active
    RIVAROXABAN USP
    2023-03-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38122
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RIVAROXABAN USP
    Issue/Submission Date
    2023-03-04
    ASK
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    • FDA
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    Sildenafil Citrate

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

    See Less

    USDMF

    Found USDMF

    25311
    Active
    SILDENAFIL CITRATE USP
    2011-11-02
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    Written Confirmation

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    Application Number
    25311
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SILDENAFIL CITRATE USP
    Issue/Submission Date
    2011-11-02
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    Sitagliptin Phosphate

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    USDMF

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    36930
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    SITAGLIPTIN PHOSPHATE
    2022-03-29
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    Application Number
    36930
    Status
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    SITAGLIPTIN PHOSPHATE
    Issue/Submission Date
    2022-03-29
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    34619
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    SUCCINYCHOLINE CHLORIDE DIHYDRATE
    2020-02-27
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    Application Number
    34619
    Status
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    SUCCINYCHOLINE CHLORIDE DIHYDRATE
    Issue/Submission Date
    2020-02-27
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    26536
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    TELMISARTAN USP
    2012-10-17
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    Indian CDSCO WC-0077
    Expired
    Telmisartan EP/BP/USP
    2019-08-13
    Application Number
    26536
    Indian CDSCO WC-0077
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-08-12
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    TELMISARTAN USP
    Telmisartan EP/BP/USP
    Issue/Submission Date
    2012-10-17
    2019-08-13
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    38471
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    VARENICLINE TARTRATE
    2023-06-22
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    Application Number
    38471
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    VARENICLINE TARTRATE
    Issue/Submission Date
    2023-06-22
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