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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Chunghwa Chemical Synthesis & Biotech

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    01 Abaloparatide Acetate (1)

    02 Baricitinib (1)

    03 Calcium Polycarbophil (1)

    04 Carfilzomib (1)

    05 Carisoprodol (1)

    06 Caspofungin (1)

    07 Dexbrompheniramine Maleate (1)

    08 Edoxaban Tosylate (1)

    09 Eslicarbazepine Acetate (1)

    10 Etelcalcetide (1)

    11 Everolimus (3)

    12 Favipiravir (1)

    13 Fluconazole (1)

    14 Glibenclamide (1)

    15 Guaifenesin (1)

    16 Icosapent Ethyl (1)

    17 Ixazomib Citrate (1)

    18 Lanreotide Acetate (1)

    19 Lovastatin (1)

    20 Metaxalone (1)

    21 Methocarbamol (1)

    22 Midostaurin (1)

    23 Mycophenolate Mofetil (2)

    24 Mycophenolate Mofetil Hydrochloride (1)

    25 Mycophenolate Sodium (2)

    26 Olopatadine Hydrochloride (1)

    27 Omega-3-Carboxylic Acids (1)

    28 Ozanimod (1)

    29 Palbociclib (1)

    30 Paracetamol (1)

    31 Pravastatin (1)

    32 Ribociclib (1)

    33 Sacubitril Sodium (1)

    34 Sirolimus (2)

    35 Tacrolimus (3)

    36 Teduglutide (1)

    37 Tofacitinib Citrate (1)

    38 Trandolapril (2)

    39 Blank (1)

    filter

    01 Active (29)

    02 Inactive (10)

    03 Blank (8)

    filter

    01 Valid (4)

    02 Blank (43)

    filter

    01 218MF10050 (1)

    02 218MF10061 (1)

    03 218MF10474 (1)

    04 218MF10666 (1)

    05 224MF10125 (1)

    06 224MF10198 (1)

    07 225MF10083 (1)

    08 303MF10065 (1)

    09 Blank (39)

    filter

    01 Blank (47)

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    • FDA
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    Pravastatin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14235
    Active
    PRAVASTATIN SODIUM USP
    1999-06-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-168 - Rev 01
    Valid
    Pravastatin sodium
    2021-03-04
    Japanese DMF

    Found JDMF

    218MF10474
    Pravastatin sodium at No. 1, Tung-H...
    2006-04-27
    Written Confirmation

    Close WC

    Application Number
    14235
    R1-CEP 2004-168 - Rev 01
    218MF10474
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PRAVASTATIN SODIUM USP
    Pravastatin sodium
    Pravastatin sodium at No. 1, Tung-H...
    Issue/Submission Date
    1999-06-24
    2021-03-04
    2006-04-27
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    Tacrolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18985
    Active
    TACROLIMUS
    2005-11-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-241 - Rev 01
    Valid
    Tacrolimus monohydrate
    2023-03-30
    Japanese DMF

    Found JDMF

    224MF10125
    Tacrolimus at No. 1, Tung-Hsing St....
    2012-07-13
    Written Confirmation

    Close WC

    Application Number
    18985
    R0-CEP 2018-241 - Rev 01
    224MF10125
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TACROLIMUS
    Tacrolimus monohydrate
    Tacrolimus at No. 1, Tung-Hsing St....
    Issue/Submission Date
    2005-11-28
    2023-03-30
    2012-07-13
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    Everolimus

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    USDMF

    Found USDMF

    26819
    Active
    EVEROLIMUS PRE-MIX USP
    2013-02-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-367 - Rev 01
    Valid
    Everolimus
    2023-05-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26819
    R0-CEP 2020-367 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EVEROLIMUS PRE-MIX USP
    Everolimus
    Issue/Submission Date
    2013-02-08
    2023-05-16
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    Everolimus

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    USDMF

    Found USDMF

    27216
    Active
    EVEROLIMUS USP
    2013-07-01
    CEP/COS

    Found CEP/COS

    CEP 2021-192 - Rev 02
    Valid
    Everolimus, With antioxidant butylh...
    2024-02-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27216
    CEP 2021-192 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EVEROLIMUS USP
    Everolimus, With antioxidant butylh...
    Issue/Submission Date
    2013-07-01
    2024-02-22
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    Methocarbamol

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    USDMF

    Found USDMF

    13080
    Active
    METHOCARBAMOL USP
    1998-07-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10061
    External regulations Methocarbamol ...
    2006-01-27
    Written Confirmation

    Close WC

    Application Number
    13080
    218MF10061
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    METHOCARBAMOL USP
    External regulations Methocarbamol ...
    Issue/Submission Date
    1998-07-17
    2006-01-27
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    Sirolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17399
    Active
    RAPAMYCIN
    2004-05-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10065
    Sirolimus at No. 1, Tung-Hsing St. ...
    2021-04-13
    Written Confirmation

    Close WC

    Application Number
    17399
    303MF10065
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RAPAMYCIN
    Sirolimus at No. 1, Tung-Hsing St. ...
    Issue/Submission Date
    2004-05-20
    2021-04-13
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    Sirolimus

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    USDMF

    Found USDMF

    31189
    Active
    RAPAMYCIN (SIROLIMUS)
    2016-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10198
    Rapamycin (production only) at No. ...
    2012-09-13
    Written Confirmation

    Close WC

    Application Number
    31189
    224MF10198
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RAPAMYCIN (SIROLIMUS)
    Rapamycin (production only) at No. ...
    Issue/Submission Date
    2016-12-30
    2012-09-13
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    Trandolapril

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    USDMF

    Found USDMF

    17573
    Active
    TRANDOLAPRIL USP
    2004-07-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10083
    Trandolapril at No. 1, Tung-Hsing S...
    2013-04-23
    Written Confirmation

    Close WC

    Application Number
    17573
    225MF10083
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TRANDOLAPRIL USP
    Trandolapril at No. 1, Tung-Hsing S...
    Issue/Submission Date
    2004-07-27
    2013-04-23
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    Fluconazole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    14419
    Inactive
    FLUCONAZOLE
    1999-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10050
    Fluconazole (production only) at No...
    2006-01-27
    Written Confirmation

    Close WC

    Application Number
    14419
    218MF10050
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FLUCONAZOLE
    Fluconazole (production only) at No...
    Issue/Submission Date
    1999-09-23
    2006-01-27
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    Baricitinib

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    USDMF

    Found USDMF

    36030
    Active
    BARICITINIB
    2021-08-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36030
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BARICITINIB
    Issue/Submission Date
    2021-08-04
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