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

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    Kyowa Hakko Bio
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    Country
    Country
    Japan
    Address
    Address
    Ohtemachi Building, 1-6-1,Ohtemachi,Chiyoda-ku, Tokyo, 100-8185, Japan
    Telephone
    Telephone
    81-3-3282-0974
    Client Email
    Email
    enquiries@pharmacompass.com
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    Website
    http://www.kyowahakko-bio.co.jp/
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    • FDA
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    Dinoprostone

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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

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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

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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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    • FDA
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    Isoleucine

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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

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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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    • FDA
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    L-Leucine API

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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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    • FDA
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    L-Histidine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-026 - Rev 05
    Valid
    Histidine Hydrochloride Monohydrate
    2022-06-03
    Japanese DMF

    Found JDMF

    224MF10011
    Japanese Pharmacopoeia L- histidine...
    2012-01-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-026 - Rev 05
    224MF10011
    Status
    Valid
     
    Filing Details
    Histidine Hydrochloride Monohydrate
    Japanese Pharmacopoeia L- histidine...
    Issue/Submission Date
    2022-06-03
    2012-01-18
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    L-Lysine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-083 - Rev 04
    Valid
    Lysine Hydrochloride
    2022-04-27
    Japanese DMF

    Found JDMF

    224MF10009
    Japanese Pharmacopoeia L- lysine hy...
    2012-01-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-083 - Rev 04
    224MF10009
    Status
    Valid
     
    Filing Details
    Lysine Hydrochloride
    Japanese Pharmacopoeia L- lysine hy...
    Issue/Submission Date
    2022-04-27
    2012-01-18
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    L-Threonine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-015 - Rev 02
    Valid
    Threonine
    2014-07-02
    Japanese DMF

    Found JDMF

    226MF10004
    Japanese Pharmacopoeia L- threonine...
    2014-01-08
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-015 - Rev 02
    226MF10004
    Status
    Valid
     
    Filing Details
    Threonine
    Japanese Pharmacopoeia L- threonine...
    Issue/Submission Date
    2014-07-02
    2014-01-08
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    Lysine Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2014-227 - Rev 01
    Valid
    Lysine acetate
    2023-10-26
    Japanese DMF

    Found JDMF

    224MF10013
    Japanese Pharmacopoeia L- lysine ac...
    2012-01-18
    Written Confirmation

    Close WC

    Application Number
    CEP 2014-227 - Rev 01
    224MF10013
    Status
    Valid
     
    Filing Details
    Lysine acetate
    Japanese Pharmacopoeia L- lysine ac...
    Issue/Submission Date
    2023-10-26
    2012-01-18
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    Olopatadine Hydrochloride

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    USDMF

    Found USDMF

    28389
    Active
    OLOPATADINE HYDROCHLORIDE DRUG SUBS...
    2014-06-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10140
    Japanese Pharmacopoeia olopatadine ...
    2014-07-31
    Written Confirmation

    Close WC

    Application Number
    28389
    226MF10140
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OLOPATADINE HYDROCHLORIDE DRUG SUBS...
    Japanese Pharmacopoeia olopatadine ...
    Issue/Submission Date
    2014-06-16
    2014-07-31
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    • FDA
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    Phenylalanine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-084 - Rev 03
    Valid
    Phenylalanine
    2014-08-06
    Japanese DMF

    Found JDMF

    217MF10232
    Japanese Pharmacopoeia L- phenylala...
    2005-06-15
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-084 - Rev 03
    217MF10232
    Status
    Valid
     
    Filing Details
    Phenylalanine
    Japanese Pharmacopoeia L- phenylala...
    Issue/Submission Date
    2014-08-06
    2005-06-15
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    Pravastatin

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    USDMF

    Caution USDMF

    16975
    Inactive
    PRAVASTATIN SODIUM
    2003-11-20
    CEP/COS

    Caution CEP/COS

    R0-CEP 2005-016 - Rev 02
    Expired
    Pravastatin sodium
    2009-11-19
    Japanese DMF

    Found JDMF

    219MF10201
    Japanese Pharmacopoeia pravastatin ...
    2007-06-13
    Written Confirmation

    Close WC

    Application Number
    16975
    R0-CEP 2005-016 - Rev 02
    219MF10201
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    PRAVASTATIN SODIUM
    Pravastatin sodium
    Japanese Pharmacopoeia pravastatin ...
    Issue/Submission Date
    2003-11-20
    2009-11-19
    2007-06-13
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    Proline

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-018 - Rev 03
    Valid
    Proline
    2017-06-02
    Japanese DMF

    Found JDMF

    229MF10028
    Japanese Pharmacopoeia L- proline (...
    2017-02-08
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-018 - Rev 03
    229MF10028
    Status
    Valid
     
    Filing Details
    Proline
    Japanese Pharmacopoeia L- proline (...
    Issue/Submission Date
    2017-06-02
    2017-02-08
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    Serine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-019 - Rev 03
    Valid
    Serine
    2016-11-09
    Japanese DMF

    Found JDMF

    228MF10226
    Japanese Pharmacopoeia L- serine (p...
    2016-12-07
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-019 - Rev 03
    228MF10226
    Status
    Valid
     
    Filing Details
    Serine
    Japanese Pharmacopoeia L- serine (p...
    Issue/Submission Date
    2016-11-09
    2016-12-07
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    Aspartic Acid API

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 1999-190 - Rev 01
    Withdrawn by Holder
    Aspartic Acid
    2010-03-08
    Japanese DMF

    Found JDMF

    219MF10189
    Japanese Pharmacopoeia L- aspartic ...
    2007-06-08
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-190 - Rev 01
    219MF10189
    Status
    Withdrawn by Holder
     
    Filing Details
    Aspartic Acid
    Japanese Pharmacopoeia L- aspartic ...
    Issue/Submission Date
    2010-03-08
    2007-06-08
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    Citicoline Sodium

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    USDMF

    Caution USDMF

    12724
    Inactive
    CITICOLINE MONOSODIUM SALT
    1997-10-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10245
    Japanese Pharmacopoeia citicoline (...
    2005-06-15
    Written Confirmation

    Close WC

    Application Number
    12724
    217MF10245
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CITICOLINE MONOSODIUM SALT
    Japanese Pharmacopoeia citicoline (...
    Issue/Submission Date
    1997-10-20
    2005-06-15
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    Glycine

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    USDMF

    Caution USDMF

    6809
    Inactive
    ALPHA-MERCAPTOPROPIONYLGLYCINE
    1987-02-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10256
    Gurishinaru at 305 Yashimanishimach...
    2009-11-30
    Written Confirmation

    Close WC

    Application Number
    6809
    221MF10256
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ALPHA-MERCAPTOPROPIONYLGLYCINE
    Gurishinaru at 305 Yashimanishimach...
    Issue/Submission Date
    1987-02-05
    2009-11-30
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    L-Glutamine

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    USDMF

    Caution USDMF

    2304
    Inactive
    L-VALINE, L-THREONINE, L-GLUTAMINE
    1974-07-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10245
    Japanese Pharmacopoeia L- glutamine...
    2008-12-04
    Written Confirmation

    Close WC

    Application Number
    2304
    220MF10245
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    L-VALINE, L-THREONINE, L-GLUTAMINE
    Japanese Pharmacopoeia L- glutamine...
    Issue/Submission Date
    1974-07-16
    2008-12-04
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    Adenine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10210
    Japanese Pharmacopoeia flavin adeni...
    2016-11-09
    Written Confirmation

    Close WC

    Application Number
    228MF10210
    Status
     
    Filing Details
    Japanese Pharmacopoeia flavin adeni...
    Issue/Submission Date
    2016-11-09
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    Adenosine 5'-Monophosphate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10190
    Outsider regulations adenosine trip...
    2017-10-30
    Written Confirmation

    Close WC

    Application Number
    229MF10190
    Status
     
    Filing Details
    Outsider regulations adenosine trip...
    Issue/Submission Date
    2017-10-30
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    Aluminium Hydroxide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10837
    Dried aluminum hydroxide gel fine \...
    2005-11-01
    Written Confirmation

    Close WC

    Application Number
    217MF10837
    Status
     
    Filing Details
    Dried aluminum hydroxide gel fine \...
    Issue/Submission Date
    2005-11-01
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    Amino Acids Mixture

    PDF Supplier PDF
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    USDMF

    Found USDMF

    3131
    Active
    AMINO ACIDS
    1978-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3131
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMINO ACIDS
    Issue/Submission Date
    1978-02-27
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    Amino Acids Mixture

    PDF Supplier PDF
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    USDMF

    Found USDMF

    3149
    Active
    AMINO ACIDS
    1978-03-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3149
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMINO ACIDS
    Issue/Submission Date
    1978-03-15
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    Benidipine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10209
    Japanese Pharmacopoeia benidipine h...
    2013-11-14
    Written Confirmation

    Close WC

    Application Number
    225MF10209
    Status
     
    Filing Details
    Japanese Pharmacopoeia benidipine h...
    Issue/Submission Date
    2013-11-14
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    Benzamidine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10058
    Japanese Pharmacopoeia Pirushikaini...
    2015-03-06
    Written Confirmation

    Close WC

    Application Number
    227MF10058
    Status
     
    Filing Details
    Japanese Pharmacopoeia Pirushikaini...
    Issue/Submission Date
    2015-03-06
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    Cetraxate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10065
    Japanese Pharmacopoeia cetraxate hy...
    2010-02-22
    Written Confirmation

    Close WC

    Application Number
    222MF10065
    Status
     
    Filing Details
    Japanese Pharmacopoeia cetraxate hy...
    Issue/Submission Date
    2010-02-22
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    Chloroprocaine HCl

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10113
    Japanese Pharmacopoeia procaine hyd...
    2010-03-23
    Written Confirmation

    Close WC

    Application Number
    222MF10113
    Status
     
    Filing Details
    Japanese Pharmacopoeia procaine hyd...
    Issue/Submission Date
    2010-03-23
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    Dl-Histidine Monohydrochloride Monohydrate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10014
    Japanese Pharmacopoeia L- histidine...
    2012-01-18
    Written Confirmation

    Close WC

    Application Number
    224MF10014
    Status
     
    Filing Details
    Japanese Pharmacopoeia L- histidine...
    Issue/Submission Date
    2012-01-18
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    Dopamine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10235
    Japanese Pharmacopoeia dopamine hyd...
    2010-09-30
    Written Confirmation

    Close WC

    Application Number
    222MF10235
    Status
     
    Filing Details
    Japanese Pharmacopoeia dopamine hyd...
    Issue/Submission Date
    2010-09-30
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    Glutathione

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    8893
    Inactive
    MANUFACTURING AND QUALITY INFORMATI...
    1990-12-17
    CEP/COS

    Caution CEP/COS

    R0-CEP 2014-174 - Rev 00
    Withdrawn by Holder
    Glutathione
    2016-06-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8893
    R0-CEP 2014-174 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    MANUFACTURING AND QUALITY INFORMATI...
    Glutathione
    Issue/Submission Date
    1990-12-17
    2016-06-09
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    Istradefylline

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10036
    Istradefylline (production only) at...
    2017-02-08
    Written Confirmation

    Close WC

    Application Number
    229MF10036
    Status
     
    Filing Details
    Istradefylline (production only) at...
    Issue/Submission Date
    2017-02-08
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    L-Arginine Hydrochloride API

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-028 - Rev 04
    Valid
    Arginine hydrochloride
    2022-06-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-028 - Rev 04
    Status
    Valid
     
    Filing Details
    Arginine hydrochloride
    Issue/Submission Date
    2022-06-20
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    L-Histidine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-027 - Rev 04
    Valid
    Histidine
    2022-05-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-027 - Rev 04
    Status
    Valid
     
    Filing Details
    Histidine
    Issue/Submission Date
    2022-05-20
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    L-VALINE

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-016 - Rev 02
    Valid
    Valine
    2014-03-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-016 - Rev 02
    Status
    Valid
     
    Filing Details
    Valine
    Issue/Submission Date
    2014-03-21
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    Lubiprostone

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10149
    Lubiprostone (for manufacturing onl...
    2022-11-30
    Written Confirmation

    Close WC

    Application Number
    304MF10149
    Status
     
    Filing Details
    Lubiprostone (for manufacturing onl...
    Issue/Submission Date
    2022-11-30
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    Magnesium Oxide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10004
    Japanese Pharmacopoeia magnesium ox...
    2010-01-07
    Written Confirmation

    Close WC

    Application Number
    222MF10004
    Status
     
    Filing Details
    Japanese Pharmacopoeia magnesium ox...
    Issue/Submission Date
    2010-01-07
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    Magnesium Oxide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10078
    Japanese Pharmacopoeia Magnesium Ox...
    2019-10-18
    Written Confirmation

    Close WC

    Application Number
    301MF10078
    Status
     
    Filing Details
    Japanese Pharmacopoeia Magnesium Ox...
    Issue/Submission Date
    2019-10-18
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    Magnesium Oxide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10079
    Japanese Pharmacopoeia Magnesium Ox...
    2019-10-18
    Written Confirmation

    Close WC

    Application Number
    301MF10079
    Status
     
    Filing Details
    Japanese Pharmacopoeia Magnesium Ox...
    Issue/Submission Date
    2019-10-18
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    Proline

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10012
    Japanese Pharmacopoeia L- proline (...
    2012-01-18
    Written Confirmation

    Close WC

    Application Number
    224MF10012
    Status
     
    Filing Details
    Japanese Pharmacopoeia L- proline (...
    Issue/Submission Date
    2012-01-18
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    Sodium Valproate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10202
    Japanese Pharmacopoeia sodium valpr...
    2016-10-31
    Written Confirmation

    Close WC

    Application Number
    228MF10202
    Status
     
    Filing Details
    Japanese Pharmacopoeia sodium valpr...
    Issue/Submission Date
    2016-10-31
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    Valsartan

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10008
    Japanese Pharmacopoeia valsartan (p...
    2013-01-18
    Written Confirmation

    Close WC

    Application Number
    225MF10008
    Status
     
    Filing Details
    Japanese Pharmacopoeia valsartan (p...
    Issue/Submission Date
    2013-01-18
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    Sanarumin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10099
    Sanarumin at 305 Yashimanishimachi,...
    2010-03-17
    Written Confirmation

    Close WC

    Application Number
    222MF10099
    Status
     
    Filing Details
    Sanarumin at 305 Yashimanishimachi,...
    Issue/Submission Date
    2010-03-17
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    Sanarumin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10100
    Sanarumin at 305 Yashimanishimachi,...
    2010-03-17
    Written Confirmation

    Close WC

    Application Number
    222MF10100
    Status
     
    Filing Details
    Sanarumin at 305 Yashimanishimachi,...
    Issue/Submission Date
    2010-03-17
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    Dinopuron -EM

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10211
    Dinopuron -EM at 530 Chokeiji, Taka...
    2016-11-09
    Written Confirmation

    Close WC

    Application Number
    228MF10211
    Status
     
    Filing Details
    Dinopuron -EM at 530 Chokeiji, Taka...
    Issue/Submission Date
    2016-11-09
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    Kumuraito

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10052
    Kumuraito at 305 Yashimanishimachi,...
    2010-02-12
    Written Confirmation

    Close WC

    Application Number
    222MF10052
    Status
     
    Filing Details
    Kumuraito at 305 Yashimanishimachi,...
    Issue/Submission Date
    2010-02-12
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