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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Kyowa Hakko Bio Co Ltd

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    01 7-Cyanoquinocarcinol (1)

    02 Acadesine (1)

    03 Aceglutamide (1)

    04 Aceglutamide Aluminium (1)

    05 Acetylpyridine Adenine Dinucleotide (1)

    06 Adenine (1)

    07 Adenosine (3)

    08 Adenosine 5'-Monophosphate (2)

    09 Alprostadil Alfadex (1)

    10 Aluminium Hydroxide (5)

    11 Amino Acids Mixture (5)

    12 Aspartic Acid API (1)

    13 Benidipine Hydrochloride (1)

    14 Benzamidine (1)

    15 Bimatoprost (1)

    16 Bucillamine (1)

    17 CCRIS 3941 (1)

    18 Calcium Aspartate (1)

    19 Cetraxate (1)

    20 Chembl2106438 (1)

    21 Chloroprocaine HCl (1)

    22 Citicoline Sodium (1)

    23 D-Panthenol (1)

    24 D-Serine API (1)

    25 DL-Valine API (1)

    26 Dacarbazine (2)

    27 Dibasic Calcium Phosphate Dihydrate (1)

    28 Dinoprostone (1)

    29 Dl-Histidine Monohydrochloride Monohydrate (1)

    30 Dopamine (2)

    31 Fostriecin (1)

    32 Glutathione (2)

    33 Glycine (1)

    34 Isoleucine (1)

    35 Istradefylline (1)

    36 L-Alanine API (1)

    37 L-Arginine (1)

    38 L-Arginine Hydrochloride API (2)

    39 L-Cysteine Hydrochloride (1)

    40 L-Glutamine (1)

    41 L-Histidine (2)

    42 L-Leucine API (1)

    43 L-Lysine Hydrochloride (1)

    44 L-Malic Acid (1)

    45 L-Threonine (2)

    46 L-VALINE (1)

    47 Latanoprost (1)

    48 Lubiprostone (1)

    49 Lysine Acetate (1)

    50 Magnesium Carbonate (2)

    51 Magnesium Oxide (12)

    52 Minocycline Hydrochloride (2)

    53 Misoprostol (2)

    54 Mitomycin (1)

    55 Olopatadine Hydrochloride (1)

    56 Oxoiron (1)

    57 Pantothenic Acid (1)

    58 Phenylalanine (1)

    59 Pravastatin (1)

    60 Proline (2)

    61 Riboflavin (1)

    62 Serine (2)

    63 Silicic Acid (H6Si2O7), Aluminum Salt (1:2) (2)

    64 Sodium Hyaluronate (2)

    65 Sodium Valproate (1)

    66 Sulfadimethoxine (1)

    67 Sulfadimethoxine Sodium (1)

    68 Taurine (1)

    69 Tranexamic Acid (1)

    70 Tryptophan (1)

    71 Ubidecarenone (1)

    72 Uracil Mustard (1)

    73 Valsartan (1)

    74 Blank (14)

    filter

    01 Active (8)

    02 Inactive (49)

    03 Blank (65)

    filter

    01 Expired (1)

    02 Valid (19)

    03 Withdrawn by Holder (3)

    04 Blank (99)

    filter

    01 217MF10114 (1)

    02 217MF10117 (1)

    03 217MF10221 (1)

    04 217MF10228 (1)

    05 217MF10229 (1)

    06 217MF10230 (1)

    07 217MF10232 (1)

    08 217MF10235 (1)

    09 217MF10240 (1)

    10 217MF10245 (1)

    11 217MF10262 (1)

    12 217MF10264 (1)

    13 217MF10837 (1)

    14 218MF10689 (1)

    15 218MF10702 (1)

    16 218MF10946 (1)

    17 219MF10189 (1)

    18 219MF10190 (1)

    19 219MF10201 (1)

    20 219MF10255 (1)

    21 219MF10256 (1)

    22 219MF10257 (1)

    23 219MF10258 (1)

    24 220MF10069 (1)

    25 220MF10244 (1)

    26 220MF10245 (1)

    27 221MF10027 (1)

    28 221MF10028 (1)

    29 221MF10030 (1)

    30 221MF10031 (1)

    31 221MF10032 (1)

    32 221MF10033 (1)

    33 221MF10072 (1)

    34 221MF10100 (1)

    35 221MF10225 (1)

    36 221MF10226 (1)

    37 221MF10246 (1)

    38 221MF10256 (1)

    39 221MF10267 (1)

    40 221MF10268 (1)

    41 222MF10004 (1)

    42 222MF10005 (1)

    43 222MF10006 (1)

    44 222MF10007 (1)

    45 222MF10008 (1)

    46 222MF10009 (1)

    47 222MF10052 (1)

    48 222MF10065 (1)

    49 222MF10099 (1)

    50 222MF10100 (1)

    51 222MF10113 (1)

    52 222MF10235 (1)

    53 222MF10247 (1)

    54 224MF10009 (1)

    55 224MF10011 (1)

    56 224MF10012 (1)

    57 224MF10013 (1)

    58 224MF10014 (1)

    59 224MF10081 (1)

    60 224MF10082 (1)

    61 225MF10008 (1)

    62 225MF10209 (1)

    63 226MF10004 (1)

    64 226MF10140 (1)

    65 227MF10058 (1)

    66 228MF10202 (1)

    67 228MF10210 (1)

    68 228MF10211 (1)

    69 228MF10226 (1)

    70 229MF10028 (1)

    71 229MF10036 (1)

    72 229MF10190 (1)

    73 230MF10070 (1)

    74 301MF10078 (1)

    75 301MF10079 (1)

    76 304MF10149 (1)

    77 Blank (46)

    filter

    01 Blank (122)

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    • FDA
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    Dinoprostone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    11274
    Active
    DINOPROSTONE DRUG SUBSTANCE
    1994-12-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-029 - Rev 02
    Valid
    Dinoprostone
    2022-08-09
    Japanese DMF

    Found JDMF

    230MF10070
    Dinoprostone at 530 Chokeiji, Takao...
    2018-06-07
    Written Confirmation

    Close WC

    Application Number
    11274
    R1-CEP 2003-029 - Rev 02
    230MF10070
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DINOPROSTONE DRUG SUBSTANCE
    Dinoprostone
    Dinoprostone at 530 Chokeiji, Takao...
    Issue/Submission Date
    1994-12-27
    2022-08-09
    2018-06-07
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    Glutathione

    PDF Supplier PDF
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    USDMF

    Found USDMF

    7799
    Active
    MANUFACTURING AND QUALITY INFORMATI...
    1988-12-02
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-328 - Rev 00
    Valid
    Glutathione
    2023-01-13
    Japanese DMF

    Found JDMF

    217MF10240
    Oxy glutathione Kyowa at 1-6-1 Otem...
    2005-06-15
    Written Confirmation

    Close WC

    Application Number
    7799
    R0-CEP 2020-328 - Rev 00
    217MF10240
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MANUFACTURING AND QUALITY INFORMATI...
    Glutathione
    Oxy glutathione Kyowa at 1-6-1 Otem...
    Issue/Submission Date
    1988-12-02
    2023-01-13
    2005-06-15
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    Latanoprost

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32989
    Active
    LATANOPROST
    2018-08-07
    CEP/COS

    Found CEP/COS

    CEP 2022-107 - Rev 01
    Valid
    Latanoprost
    2024-01-29
    Japanese DMF

    Found JDMF

    220MF10069
    Latanoprost at 530 Chokeiji, Takaok...
    2008-02-25
    Written Confirmation

    Close WC

    Application Number
    32989
    CEP 2022-107 - Rev 01
    220MF10069
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LATANOPROST
    Latanoprost
    Latanoprost at 530 Chokeiji, Takaok...
    Issue/Submission Date
    2018-08-07
    2024-01-29
    2008-02-25
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    Tranexamic Acid

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    USDMF

    Found USDMF

    26128
    Active
    TRANEXAMIC ACID DRUG SUBSTANCE
    2012-06-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-271 - Rev 02
    Valid
    Tranexamic acid
    2022-09-14
    Japanese DMF

    Found JDMF

    224MF10082
    Japanese Pharmacopoeia tranexamic a...
    2012-04-13
    Written Confirmation

    Close WC

    Application Number
    26128
    R1-CEP 2012-271 - Rev 02
    224MF10082
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRANEXAMIC ACID DRUG SUBSTANCE
    Tranexamic acid
    Japanese Pharmacopoeia tranexamic a...
    Issue/Submission Date
    2012-06-05
    2022-09-14
    2012-04-13
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    Isoleucine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    2623
    Inactive
    L-ISOLEUCINE
    1976-02-11
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-014 - Rev 04
    Valid
    Isoleucine
    2020-08-14
    Japanese DMF

    Found JDMF

    217MF10221
    Japanese Pharmacopoeia L- isoleucin...
    2005-06-15
    Written Confirmation

    Close WC

    Application Number
    2623
    R1-CEP 1999-014 - Rev 04
    217MF10221
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-ISOLEUCINE
    Isoleucine
    Japanese Pharmacopoeia L- isoleucin...
    Issue/Submission Date
    1976-02-11
    2020-08-14
    2005-06-15
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    L-Alanine API

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    2621
    Inactive
    L-ALANINE
    1976-03-02
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-013 - Rev 02
    Valid
    Alanine
    2014-07-30
    Japanese DMF

    Found JDMF

    222MF10247
    Japanese Pharmacopoeia L- alanine (...
    2010-10-28
    Written Confirmation

    Close WC

    Application Number
    2621
    R1-CEP 1999-013 - Rev 02
    222MF10247
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-ALANINE
    Alanine
    Japanese Pharmacopoeia L- alanine (...
    Issue/Submission Date
    1976-03-02
    2014-07-30
    2010-10-28
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    L-Arginine Hydrochloride API

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    USDMF

    Caution USDMF

    2170
    Inactive
    L-ARGININE, L-ARGININE MONOHYDROCHL...
    1973-10-24
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-109 - Rev 05
    Valid
    Arginine
    2022-03-18
    Japanese DMF

    Found JDMF

    219MF10190
    Japanese Pharmacopoeia L- arginine ...
    2007-06-08
    Written Confirmation

    Close WC

    Application Number
    2170
    R1-CEP 1998-109 - Rev 05
    219MF10190
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-ARGININE, L-ARGININE MONOHYDROCHL...
    Arginine
    Japanese Pharmacopoeia L- arginine ...
    Issue/Submission Date
    1973-10-24
    2022-03-18
    2007-06-08
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    L-Leucine API

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    2622
    Inactive
    L-LEUCINE
    1976-02-04
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-160 - Rev 03
    Valid
    Leucine
    2013-08-30
    Japanese DMF

    Found JDMF

    217MF10235
    Japanese Pharmacopoeia L- leucine (...
    2005-06-15
    Written Confirmation

    Close WC

    Application Number
    2622
    R1-CEP 1999-160 - Rev 03
    217MF10235
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-LEUCINE
    Leucine
    Japanese Pharmacopoeia L- leucine (...
    Issue/Submission Date
    1976-02-04
    2013-08-30
    2005-06-15
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    Tryptophan

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    USDMF

    Caution USDMF

    2247
    Inactive
    L-TRYPTOPHAN, L-TYROSINE, L-ASPARTI...
    1974-03-12
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-189 - Rev 03
    Valid
    Tryptophan
    2022-12-05
    Japanese DMF

    Found JDMF

    217MF10228
    Japanese Pharmacopoeia L- tryptopha...
    2005-06-15
    Written Confirmation

    Close WC

    Application Number
    2247
    R1-CEP 1999-189 - Rev 03
    217MF10228
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-TRYPTOPHAN, L-TYROSINE, L-ASPARTI...
    Tryptophan
    Japanese Pharmacopoeia L- tryptopha...
    Issue/Submission Date
    1974-03-12
    2022-12-05
    2005-06-15
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    Bimatoprost

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    USDMF

    Found USDMF

    21681
    Active
    BIMATOPROST DRUG SUBSTANCE
    2008-06-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10081
    Bimatoprost (production only) at 53...
    2012-04-13
    Written Confirmation

    Close WC

    Application Number
    21681
    224MF10081
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BIMATOPROST DRUG SUBSTANCE
    Bimatoprost (production only) at 53...
    Issue/Submission Date
    2008-06-10
    2012-04-13
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