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

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    Amino Chemicals
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    Malta
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    Amino Chemicals Ltd. A50, Industrial EstateMRS3000 Marsa– Malta
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    Telephone
    356 224 895 23
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    enquiries@pharmacompass.com
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    • FDA
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    Terbinafine Hydrochloride

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    USDMF

    Found USDMF

    16283
    Active
    TERBINAFINE HYDROCHLORIDE
    2002-11-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-346 - Rev 01
    Valid
    Terbinafine hydrochloride
    2017-09-04
    Japanese DMF

    Found JDMF

    221MF10044
    Terbinafine hydrochloride at A61, I...
    2009-02-25
    Written Confirmation

    Close WC

    Application Number
    16283
    R1-CEP 2007-346 - Rev 01
    221MF10044
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TERBINAFINE HYDROCHLORIDE
    Terbinafine hydrochloride
    Terbinafine hydrochloride at A61, I...
    Issue/Submission Date
    2002-11-28
    2017-09-04
    2009-02-25
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    • FDA
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    Benazepril Hydrochloride

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    USDMF

    Found USDMF

    19148
    Active
    BENAZEPRIL HYDROCHLORIDE
    2006-02-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11297
    Benazepril hydrochloride "KOA" at M...
    2005-12-22
    Written Confirmation

    Close WC

    Application Number
    19148
    217MF11297
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BENAZEPRIL HYDROCHLORIDE
    Benazepril hydrochloride "KOA" at M...
    Issue/Submission Date
    2006-02-02
    2005-12-22
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    • FDA
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    Pramipexole Dihydrochloride

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    USDMF

    Found USDMF

    18297
    Active
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    2005-04-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-127 - Rev 02
    Valid
    Pramipexole dihydrochloride monohyd...
    2018-09-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18297
    R1-CEP 2011-127 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
    Pramipexole dihydrochloride monohyd...
    Issue/Submission Date
    2005-04-21
    2018-09-25
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    • FDA
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    Telmisartan

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    USDMF

    Found USDMF

    20882
    Active
    TELMISARTAN
    2007-09-26
    CEP/COS

    Caution CEP/COS

    R0-CEP 2010-093 - Rev 00
    Withdrawn by Holder
    Telmisartan
    2012-10-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20882
    R0-CEP 2010-093 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    TELMISARTAN
    Telmisartan
    Issue/Submission Date
    2007-09-26
    2012-10-11
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    • FDA
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    Ziprasidone Hydrochloride

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    USDMF

    Caution USDMF

    20105
    Inactive
    ZIPRASIDONE HYDROCHLORIDE ANHYDROUS
    2006-12-27
    CEP/COS

    Found CEP/COS

    CEP 2010-358 - Rev 01
    Valid
    Ziprasidone hydrochloride monohydra...
    2023-10-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20105
    CEP 2010-358 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ZIPRASIDONE HYDROCHLORIDE ANHYDROUS
    Ziprasidone hydrochloride monohydra...
    Issue/Submission Date
    2006-12-27
    2023-10-06
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    • FDA
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    Bosentan Hydrate

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    USDMF

    Found USDMF

    23455
    Active
    BOSENTAN MONOHYDRATE
    2010-01-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23455
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BOSENTAN MONOHYDRATE
    Issue/Submission Date
    2010-01-14
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    • FDA
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    Fexofenadine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10120
    Fexofenadine hydrochloride at A61, ...
    2011-07-28
    Written Confirmation

    Close WC

    Application Number
    223MF10120
    Status
     
    Filing Details
    Fexofenadine hydrochloride at A61, ...
    Issue/Submission Date
    2011-07-28
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    • FDA
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    Miglustat

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10103
    Miglstadt at MRA050X, INDUSTRIAL ES...
    2022-07-27
    Written Confirmation

    Close WC

    Application Number
    304MF10103
    Status
     
    Filing Details
    Miglstadt at MRA050X, INDUSTRIAL ES...
    Issue/Submission Date
    2022-07-27
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    • FDA
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    Paliperidone

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    USDMF

    Found USDMF

    24263
    Active
    PALIPERIDONE USP
    2010-10-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24263
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PALIPERIDONE USP
    Issue/Submission Date
    2010-10-06
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    • FDA
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    Pantoprazole Sodium

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    USDMF

    Caution USDMF

    20205
    Inactive
    PANTOPRAZOLE SODIUM SESQUIHYDRATE
    2007-01-24
    CEP/COS

    Caution CEP/COS

    R0-CEP 2009-046 - Rev 00
    Expired
    Pantoprazole sodium sesquihydrate
    2010-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20205
    R0-CEP 2009-046 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    PANTOPRAZOLE SODIUM SESQUIHYDRATE
    Pantoprazole sodium sesquihydrate
    Issue/Submission Date
    2007-01-24
    2010-07-21
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    • FDA
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    Pramipexole Dihydrochloride

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    USDMF

    Found USDMF

    32872
    Active
    PRAMIPEXOLE BASE
    2018-11-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32872
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PRAMIPEXOLE BASE
    Issue/Submission Date
    2018-11-07
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    • FDA
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    Rasagiline Mesylate

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    USDMF

    Found USDMF

    22667
    Active
    RASAGILINE MESYLATE
    2009-03-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22667
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RASAGILINE MESYLATE
    Issue/Submission Date
    2009-03-25
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    • FDA
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    Tolterodine Tartrate

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    USDMF

    Found USDMF

    20093
    Active
    TOLTERODINE TARTRATE
    2006-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20093
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TOLTERODINE TARTRATE
    Issue/Submission Date
    2006-12-21
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    • FDA
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    Ziprasidone Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27259
    Active
    ZIPRASIDONE HYDROCHLORIDE MONOHYDRA...
    2013-07-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27259
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ZIPRASIDONE HYDROCHLORIDE MONOHYDRA...
    Issue/Submission Date
    2013-07-15
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    • FDA
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    Adapalene

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20106
    Inactive
    ADAPALENE
    2006-12-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20106
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ADAPALENE
    Issue/Submission Date
    2006-12-27
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    • FDA
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    Fosinopril

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    15326
    Inactive
    FOSINOPRIL SODIUM
    2001-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15326
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FOSINOPRIL SODIUM
    Issue/Submission Date
    2001-02-28
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    • FDA
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    Granisetron Hydrochloride

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    17476
    Inactive
    GRANISETRON HYDROCHLORIDE
    2004-06-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17476
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GRANISETRON HYDROCHLORIDE
    Issue/Submission Date
    2004-06-18
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    • FDA
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    Imiquimod

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20736
    Inactive
    IMIQUIMOD
    2007-07-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20736
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    IMIQUIMOD
    Issue/Submission Date
    2007-07-30
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    • FDA
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    Modafinil

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23146
    Inactive
    (R)-MODAFINIL
    2009-10-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23146
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    (R)-MODAFINIL
    Issue/Submission Date
    2009-10-02
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    • FDA
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    Olmesartan Medoxomil

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    22721
    Inactive
    OLMESARTAN MEDOXOMIL
    2009-04-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22721
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OLMESARTAN MEDOXOMIL
    Issue/Submission Date
    2009-04-14
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    • FDA
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    Rabeprazole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20818
    Inactive
    RABEPRAZOLE SODIUM MONOHYDRATE
    2007-08-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20818
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    RABEPRAZOLE SODIUM MONOHYDRATE
    Issue/Submission Date
    2007-08-29
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    • FDA
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    Venlafaxine Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    18878
    Inactive
    VENLAFAXINE HYDROCHLORIDE
    2005-10-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18878
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    VENLAFAXINE HYDROCHLORIDE
    Issue/Submission Date
    2005-10-14
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    • FDA
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    Zaleplon

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    16785
    Inactive
    ZALEPLON
    2003-08-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16785
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ZALEPLON
    Issue/Submission Date
    2003-08-20
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    Apixaban

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Armodafinil

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Benazepril

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Bilastine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    Brivaracetam

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Cinacalcet Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Cyproheptadine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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