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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Ajinomoto Company

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    Ajinomoto Company
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    Country
    Japan
    Address
    Address
    15-1, Kyobashi 1-chome, Chuo-ku, Tokyo 104-8315
    Telephone
    Telephone
    +81 3 5250 8111
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    Email
    enquiries@pharmacompass.com
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    https://www.ajinomoto.com/
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    • FDA
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    Aspartic Acid API

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    USDMF

    Found USDMF

    31648
    Active
    L-ASPARTIC ACID
    2017-04-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-143 - Rev 04
    Valid
    Aspartic Acid
    2018-02-01
    Japanese DMF

    Found JDMF

    218MF10641
    Japanese Pharmacopoeia L- aspartic ...
    2006-07-20
    Written Confirmation

    Close WC

    Application Number
    31648
    R1-CEP 2003-143 - Rev 04
    218MF10641
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-ASPARTIC ACID
    Aspartic Acid
    Japanese Pharmacopoeia L- aspartic ...
    Issue/Submission Date
    2017-04-20
    2018-02-01
    2006-07-20
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    Etilevodopa

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    USDMF

    Found USDMF

    12379
    Active
    LEVODOPA
    1997-02-19
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-001 - Rev 01
    Valid
    Levodopa
    2007-10-19
    Japanese DMF

    Found JDMF

    302MF10140
    L-Dihydroxyphenylalanine at 1-15-1 ...
    2020-11-26
    Written Confirmation

    Close WC

    Application Number
    12379
    R1-CEP 1999-001 - Rev 01
    302MF10140
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEVODOPA
    Levodopa
    L-Dihydroxyphenylalanine at 1-15-1 ...
    Issue/Submission Date
    1997-02-19
    2007-10-19
    2020-11-26
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    Isoleucine

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    USDMF

    Found USDMF

    21991
    Active
    L-ISOLEUCINE
    2008-07-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-296 - Rev 00
    Valid
    Isoleucine, SA
    2020-08-14
    Japanese DMF

    Found JDMF

    226MF10084
    Japanese Pharmacopoeia L-isoleucine...
    2014-05-09
    Written Confirmation

    Close WC

    Application Number
    21991
    R1-CEP 2013-296 - Rev 00
    226MF10084
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-ISOLEUCINE
    Isoleucine, SA
    Japanese Pharmacopoeia L-isoleucine...
    Issue/Submission Date
    2008-07-17
    2020-08-14
    2014-05-09
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    L-Alanine API

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    USDMF

    Found USDMF

    29142
    Active
    L-ALANINE
    2015-02-23
    CEP/COS

    Found CEP/COS

    CEP 2018-145 - Rev 01
    Valid
    Alanine, II
    2023-12-20
    Japanese DMF

    Found JDMF

    223MF10057
    Japanese Pharmacopoeia L- alanine (...
    2011-04-28
    Written Confirmation

    Close WC

    Application Number
    29142
    CEP 2018-145 - Rev 01
    223MF10057
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-ALANINE
    Alanine, II
    Japanese Pharmacopoeia L- alanine (...
    Issue/Submission Date
    2015-02-23
    2023-12-20
    2011-04-28
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    L-Alanine API

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    USDMF

    Found USDMF

    31555
    Active
    L-ALANINE
    2017-03-21
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-105 - Rev 05
    Valid
    Alanine
    2018-06-22
    Japanese DMF

    Found JDMF

    222MF10252
    Japanese Pharmacopoeia L- alanine (...
    2010-10-28
    Written Confirmation

    Close WC

    Application Number
    31555
    R1-CEP 1998-105 - Rev 05
    222MF10252
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-ALANINE
    Alanine
    Japanese Pharmacopoeia L- alanine (...
    Issue/Submission Date
    2017-03-21
    2018-06-22
    2010-10-28
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    L-Arginine

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    USDMF

    Found USDMF

    31646
    Active
    L-ARGININE
    2017-04-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-190 - Rev 00
    Valid
    Arginine, SA
    2022-09-29
    Japanese DMF

    Found JDMF

    218MF10640
    Japanese Pharmacopoeia L- arginine ...
    2006-07-20
    Written Confirmation

    Close WC

    Application Number
    31646
    R0-CEP 2022-190 - Rev 00
    218MF10640
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-ARGININE
    Arginine, SA
    Japanese Pharmacopoeia L- arginine ...
    Issue/Submission Date
    2017-04-20
    2022-09-29
    2006-07-20
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    L-Glutamic Acid

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    USDMF

    Found USDMF

    31649
    Active
    L-GLUTAMIC ACID
    2017-04-20
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-066 - Rev 01
    Valid
    Glutamic Acid
    2006-09-29
    Japanese DMF

    Found JDMF

    224MF10004
    Japanese Pharmacopoeia L- glutamic ...
    2012-01-18
    Written Confirmation

    Close WC

    Application Number
    31649
    R1-CEP 1998-066 - Rev 01
    224MF10004
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-GLUTAMIC ACID
    Glutamic Acid
    Japanese Pharmacopoeia L- glutamic ...
    Issue/Submission Date
    2017-04-20
    2006-09-29
    2012-01-18
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    L-Histidine

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    USDMF

    Found USDMF

    31562
    Active
    L-HISTIDINE
    2017-03-21
    CEP/COS

    Found CEP/COS

    CEP 2014-269 - Rev 01
    Valid
    Histidine, SA
    2023-09-15
    Japanese DMF

    Found JDMF

    224MF10006
    Japanese Pharmacopoeia L- histidine...
    2012-01-18
    Written Confirmation

    Close WC

    Application Number
    31562
    CEP 2014-269 - Rev 01
    224MF10006
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-HISTIDINE
    Histidine, SA
    Japanese Pharmacopoeia L- histidine...
    Issue/Submission Date
    2017-03-21
    2023-09-15
    2012-01-18
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    L-Lysine Hydrochloride

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    USDMF

    Found USDMF

    26280
    Active
    L-LYSINE MONOHYDROCHLORIDE
    2012-08-02
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-065 - Rev 02
    Valid
    Lysine Hydrochloride
    2013-12-20
    Japanese DMF

    Found JDMF

    223MF10042
    Japanese Pharmacopoeia L- lysine hy...
    2011-03-10
    Written Confirmation

    Close WC

    Application Number
    26280
    R1-CEP 1998-065 - Rev 02
    223MF10042
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-LYSINE MONOHYDROCHLORIDE
    Lysine Hydrochloride
    Japanese Pharmacopoeia L- lysine hy...
    Issue/Submission Date
    2012-08-02
    2013-12-20
    2011-03-10
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    L-Threonine

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    USDMF

    Found USDMF

    29306
    Active
    L-THREONINE
    2015-04-17
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-097 - Rev 07
    Valid
    Threonine
    2018-05-17
    Japanese DMF

    Found JDMF

    220MF10073
    Japanese Pharmacopoeia L- threonine...
    2008-03-14
    Written Confirmation

    Close WC

    Application Number
    29306
    R1-CEP 1996-097 - Rev 07
    220MF10073
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-THREONINE
    Threonine
    Japanese Pharmacopoeia L- threonine...
    Issue/Submission Date
    2015-04-17
    2018-05-17
    2008-03-14
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    L-Threonine

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    USDMF

    Found USDMF

    31564
    Active
    L-THREONINE
    2017-03-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-204 - Rev 01
    Valid
    Threonine, L-Threonine II
    2021-09-27
    Japanese DMF

    Found JDMF

    218MF10907
    Japanese Pharmacopoeia L- threonine...
    2006-11-10
    Written Confirmation

    Close WC

    Application Number
    31564
    R1-CEP 2014-204 - Rev 01
    218MF10907
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-THREONINE
    Threonine, L-Threonine II
    Japanese Pharmacopoeia L- threonine...
    Issue/Submission Date
    2017-03-21
    2021-09-27
    2006-11-10
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    L-Tyrosine API

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    USDMF

    Found USDMF

    31653
    Active
    L-TYROSINE
    2017-04-20
    CEP/COS

    Found CEP/COS

    CEP 1999-023 - Rev 03
    Valid
    Tyrosine
    2024-02-14
    Japanese DMF

    Found JDMF

    226MF10025
    Japanese Pharmacopoeia L- Tyrosine ...
    2014-02-05
    Written Confirmation

    Close WC

    Application Number
    31653
    CEP 1999-023 - Rev 03
    226MF10025
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-TYROSINE
    Tyrosine
    Japanese Pharmacopoeia L- Tyrosine ...
    Issue/Submission Date
    2017-04-20
    2024-02-14
    2014-02-05
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    Lysine Acetate

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    USDMF

    Found USDMF

    31558
    Active
    L-LYSINE ACETATE
    2017-03-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-063 - Rev 02
    Valid
    Lysine acetate, NC
    2023-08-10
    Japanese DMF

    Found JDMF

    227MF10116
    Japanese Pharmacopoeia L- lysine ac...
    2015-04-21
    Written Confirmation

    Close WC

    Application Number
    31558
    R1-CEP 2014-063 - Rev 02
    227MF10116
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-LYSINE ACETATE
    Lysine acetate, NC
    Japanese Pharmacopoeia L- lysine ac...
    Issue/Submission Date
    2017-03-21
    2023-08-10
    2015-04-21
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    • FDA
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    Phenylalanine

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    USDMF

    Found USDMF

    29140
    Active
    L-PHENYLALANINE
    2015-02-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-132 - Rev 00
    Valid
    Phenylalanine, SA
    2020-07-20
    Japanese DMF

    Found JDMF

    226MF10085
    Japanese Pharmacopoeia L- phenylala...
    2014-05-09
    Written Confirmation

    Close WC

    Application Number
    29140
    R1-CEP 2014-132 - Rev 00
    226MF10085
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-PHENYLALANINE
    Phenylalanine, SA
    Japanese Pharmacopoeia L- phenylala...
    Issue/Submission Date
    2015-02-23
    2020-07-20
    2014-05-09
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    Phenylalanine

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    USDMF

    Found USDMF

    31652
    Active
    L-PHENYLALANINE
    2017-04-20
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-067 - Rev 02
    Valid
    Phenylalanine
    2014-10-17
    Japanese DMF

    Found JDMF

    217MF10376
    Japanese Pharmacopoeia L- phenylala...
    2005-07-27
    Written Confirmation

    Close WC

    Application Number
    31652
    R1-CEP 1998-067 - Rev 02
    217MF10376
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-PHENYLALANINE
    Phenylalanine
    Japanese Pharmacopoeia L- phenylala...
    Issue/Submission Date
    2017-04-20
    2014-10-17
    2005-07-27
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    Proline

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31557
    Active
    L-PROLINE
    2017-03-21
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-064 - Rev 04
    Valid
    Proline
    2018-05-17
    Japanese DMF

    Found JDMF

    224MF10008
    Japanese Pharmacopoeia L- proline (...
    2012-01-18
    Written Confirmation

    Close WC

    Application Number
    31557
    R1-CEP 1998-064 - Rev 04
    224MF10008
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-PROLINE
    Proline
    Japanese Pharmacopoeia L- proline (...
    Issue/Submission Date
    2017-03-21
    2018-05-17
    2012-01-18
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    Serine

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    USDMF

    Found USDMF

    31559
    Active
    L-SERINE
    2017-03-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-211 - Rev 00
    Valid
    Serine, Process II
    2019-06-21
    Japanese DMF

    Found JDMF

    226MF10080
    Japanese Pharmacopoeia L- serine (p...
    2014-05-02
    Written Confirmation

    Close WC

    Application Number
    31559
    R1-CEP 2013-211 - Rev 00
    226MF10080
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-SERINE
    Serine, Process II
    Japanese Pharmacopoeia L- serine (p...
    Issue/Submission Date
    2017-03-21
    2019-06-21
    2014-05-02
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    Tryptophan

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    USDMF

    Found USDMF

    31560
    Active
    L-TRYPTOPHAN
    2017-03-21
    CEP/COS

    Found CEP/COS

    CEP 1998-137 - Rev 06
    Valid
    Tryptophan
    2024-02-12
    Japanese DMF

    Found JDMF

    227MF10115
    Japanese Pharmacopoeia L- tryptopha...
    2015-04-21
    Written Confirmation

    Close WC

    Application Number
    31560
    CEP 1998-137 - Rev 06
    227MF10115
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-TRYPTOPHAN
    Tryptophan
    Japanese Pharmacopoeia L- tryptopha...
    Issue/Submission Date
    2017-03-21
    2024-02-12
    2015-04-21
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      Acetylcysteine

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      USDMF

      Caution USDMF

      7816
      Inactive
      N-ACETYL-L-CYSTEINE
      1988-12-15
      CEP/COS

      Found CEP/COS

      R1-CEP 1996-080 - Rev 04
      Valid
      Acetylcysteine
      2020-06-19
      Japanese DMF

      Found JDMF

      224MF10007
      Japanese Pharmacopoeia-acetylcystei...
      2012-01-18
      Written Confirmation

      Close WC

      Application Number
      7816
      R1-CEP 1996-080 - Rev 04
      224MF10007
      Status
      Inactive
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      N-ACETYL-L-CYSTEINE
      Acetylcysteine
      Japanese Pharmacopoeia-acetylcystei...
      Issue/Submission Date
      1988-12-15
      2020-06-19
      2012-01-18
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      Isoleucine

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      USDMF

      Found USDMF

      29143
      Active
      L-ISOLEUCINE
      2015-02-23
      CEP/COS

      Caution CEP/COS

      R1-CEP 1998-122 - Rev 03
      Withdrawn by Holder
      Isoleucine
      2013-09-25
      Japanese DMF

      Found JDMF

      219MF10243
      Japanese Pharmacopoeia L- isoleucin...
      2007-07-17
      Written Confirmation

      Close WC

      Application Number
      29143
      R1-CEP 1998-122 - Rev 03
      219MF10243
      Status
      Active
      Fees Paid
      Reviewed
      Withdrawn by Holder
       
      Filing Details
      L-ISOLEUCINE
      Isoleucine
      Japanese Pharmacopoeia L- isoleucin...
      Issue/Submission Date
      2015-02-23
      2013-09-25
      2007-07-17
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      L-Arginine Hydrochloride API

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      USDMF

      Caution USDMF

      748
      Inactive
      L-ARGININE MONOHYDROCHLORIDE
      1963-12-10
      CEP/COS

      Found CEP/COS

      R0-CEP 2022-189 - Rev 00
      Valid
      Arginine hydrochloride, SA
      2022-09-28
      Japanese DMF

      Found JDMF

      218MF10637
      Japanese Pharmacopoeia L- arginine ...
      2006-07-20
      Written Confirmation

      Close WC

      Application Number
      748
      R0-CEP 2022-189 - Rev 00
      218MF10637
      Status
      Inactive
      Fees Paid
      N/A
      Valid
       
      Filing Details
      L-ARGININE MONOHYDROCHLORIDE
      Arginine hydrochloride, SA
      Japanese Pharmacopoeia L- arginine ...
      Issue/Submission Date
      1963-12-10
      2022-09-28
      2006-07-20
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      L-Leucine API

      PDF Supplier PDF
      URL Supplier Web Content
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      See Less

      USDMF

      Caution USDMF

      21593
      Inactive
      L-LEUCINE
      2008-04-29
      CEP/COS

      Found CEP/COS

      R1-CEP 2012-052 - Rev 01
      Valid
      Leucine
      2023-03-08
      Japanese DMF

      Found JDMF

      217MF10807
      Japanese Pharmacopoeia L- leucine (...
      2005-11-01
      Written Confirmation

      Close WC

      Application Number
      21593
      R1-CEP 2012-052 - Rev 01
      217MF10807
      Status
      Inactive
      Fees Paid
      N/A
      Valid
       
      Filing Details
      L-LEUCINE
      Leucine
      Japanese Pharmacopoeia L- leucine (...
      Issue/Submission Date
      2008-04-29
      2023-03-08
      2005-11-01
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      Amino Acids Mixture

      PDF Supplier PDF
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      USDMF

      Found USDMF

      1076
      Active
      AMINO ACID PRODUCTS
      1967-08-15
      CEP/COS

      Found CEP/COS

      R1-CEP 2009-100 - Rev 00
      Valid
      Isoleucine, Limeira Amino Acid site
      2014-12-16
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      1076
      R1-CEP 2009-100 - Rev 00
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      AMINO ACID PRODUCTS
      Isoleucine, Limeira Amino Acid site
      Issue/Submission Date
      1967-08-15
      2014-12-16
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      Dl-Histidine Monohydrochloride Monohydrate

      PDF Supplier PDF
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      USDMF

      Found USDMF

      31563
      Active
      L-HISTIDINE MONOHYDROCHLORIDE MONOH...
      2017-03-21
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Found JDMF

      224MF10005
      Japanese Pharmacopoeia L- histidine...
      2012-01-18
      Written Confirmation

      Close WC

      Application Number
      31563
      224MF10005
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      L-HISTIDINE MONOHYDROCHLORIDE MONOH...
      Japanese Pharmacopoeia L- histidine...
      Issue/Submission Date
      2017-03-21
      2012-01-18
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      Etilevodopa

      PDF Supplier PDF
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      USDMF

      Found USDMF

      31654
      Active
      LEVODOPA
      2017-04-20
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Found JDMF

      221MF10284
      Japanese Pharmacopoeia levodopa (pr...
      2009-12-22
      Written Confirmation

      Close WC

      Application Number
      31654
      221MF10284
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      LEVODOPA
      Japanese Pharmacopoeia levodopa (pr...
      Issue/Submission Date
      2017-04-20
      2009-12-22
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      L-Arginine Hydrochloride API

      PDF Supplier PDF
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      USDMF

      Found USDMF

      31647
      Active
      L-ARGININE MONOHYDROCHLORIDE
      2017-04-20
      CEP/COS

      Found CEP/COS

      R1-CEP 1998-104 - Rev 04
      Valid
      Arginine
      2014-09-30
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      31647
      R1-CEP 1998-104 - Rev 04
      Status
      Active
      Fees Paid
      N/A
      Valid
       
      Filing Details
      L-ARGININE MONOHYDROCHLORIDE
      Arginine
      Issue/Submission Date
      2017-04-20
      2014-09-30
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        L-Cysteine

        PDF Supplier PDF
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        USDMF

        Close USDMF

        CEP/COS

        Found CEP/COS

        R1-CEP 2003-159 - Rev 03
        Valid
        Cysteine Hydrochloride Monohydrate
        2014-08-05
        Japanese DMF

        Found JDMF

        220MF10015
        Japanese Pharmacopoeia L- cysteine ...
        2008-01-09
        Written Confirmation

        Close WC

        Application Number
        R1-CEP 2003-159 - Rev 03
        220MF10015
        Status
        Valid
         
        Filing Details
        Cysteine Hydrochloride Monohydrate
        Japanese Pharmacopoeia L- cysteine ...
        Issue/Submission Date
        2014-08-05
        2008-01-09
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          L-Cysteine Hydrochloride

          PDF Supplier PDF
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          USDMF

          Found USDMF

          21364
          Active
          L-CYSTEINE HYDROCHLORIDE MONOHYDRAT...
          2008-02-26
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Found JDMF

          220MF10016
          Japanese Pharmacopoeia L- cysteine ...
          2008-01-09
          Written Confirmation

          Close WC

          Application Number
          21364
          220MF10016
          Status
          Active
          Fees Unpaid
          Reviewed
           
          Filing Details
          L-CYSTEINE HYDROCHLORIDE MONOHYDRAT...
          Japanese Pharmacopoeia L- cysteine ...
          Issue/Submission Date
          2008-02-26
          2008-01-09
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          L-Leucine API

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

          See Less

          USDMF

          Found USDMF

          21761
          Active
          L-LEUCINE
          2008-07-03
          CEP/COS

          Found CEP/COS

          R1-CEP 2008-233 - Rev 01
          Valid
          Leucine
          2018-05-17
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          21761
          R1-CEP 2008-233 - Rev 01
          Status
          Active
          Fees Paid
          Reviewed
          Valid
           
          Filing Details
          L-LEUCINE
          Leucine
          Issue/Submission Date
          2008-07-03
          2018-05-17
          ASK
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          L-Lysine Hydrochloride

          PDF Supplier PDF
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          See Less

          USDMF

          Found USDMF

          31651
          Active
          L-LYSINE MONOHYDROCHLORIDE
          2017-04-20
          CEP/COS

          Found CEP/COS

          R1-CEP 2012-249 - Rev 01
          Valid
          Lysine Hydrochloride, SA
          2021-10-22
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          31651
          R1-CEP 2012-249 - Rev 01
          Status
          Active
          Fees Paid
          Reviewed
          Valid
           
          Filing Details
          L-LYSINE MONOHYDROCHLORIDE
          Lysine Hydrochloride, SA
          Issue/Submission Date
          2017-04-20
          2021-10-22
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          L-VALINE

          PDF Supplier PDF
          URL Supplier Web Content
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          USDMF

          Found USDMF

          29141
          Active
          L-VALINE
          2015-02-23
          CEP/COS

          Found CEP/COS

          CEP 2014-056 - Rev 01
          Valid
          Valine, SA
          2024-02-09
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          29141
          CEP 2014-056 - Rev 01
          Status
          Active
          Fees Paid
          Reviewed
          Valid
           
          Filing Details
          L-VALINE
          Valine, SA
          Issue/Submission Date
          2015-02-23
          2024-02-09
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          L-VALINE

          PDF Supplier PDF
          URL Supplier Web Content
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          USDMF

          Found USDMF

          31561
          Active
          L-VALINE
          2017-03-21
          CEP/COS

          Found CEP/COS

          R1-CEP 1998-106 - Rev 06
          Valid
          Valine
          2018-06-22
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          31561
          R1-CEP 1998-106 - Rev 06
          Status
          Active
          Fees Paid
          Reviewed
          Valid
           
          Filing Details
          L-VALINE
          Valine
          Issue/Submission Date
          2017-03-21
          2018-06-22
          ASK
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          Serine

          PDF Supplier PDF
          URL Supplier Web Content
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          See Less

          USDMF

          Found USDMF

          31568
          Active
          L-SERINE (PROCESS II)
          2017-03-21
          CEP/COS

          Found CEP/COS

          R1-CEP 1999-159 - Rev 04
          Valid
          Serine
          2018-05-17
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          31568
          R1-CEP 1999-159 - Rev 04
          Status
          Active
          Fees Paid
          Reviewed
          Valid
           
          Filing Details
          L-SERINE (PROCESS II)
          Serine
          Issue/Submission Date
          2017-03-21
          2018-05-17
          ASK
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          L-Glutamine

          PDF Supplier PDF
          URL Supplier Web Content
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          See Less

          USDMF

          Caution USDMF

          10884
          Inactive
          GLYCYL-L-GLUTAMINE HYDRATE
          1994-04-21
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Found JDMF

          220MF10239
          Japanese Pharmacopoeia L- glutamine...
          2008-11-25
          Written Confirmation

          Close WC

          Application Number
          10884
          220MF10239
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          GLYCYL-L-GLUTAMINE HYDRATE
          Japanese Pharmacopoeia L- glutamine...
          Issue/Submission Date
          1994-04-21
          2008-11-25
          ASK
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          • FDA
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          L-Leucine API

          PDF Supplier PDF
          URL Supplier Web Content
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          See Less

          USDMF

          Found USDMF

          31556
          Active
          L-LEUCINE
          2017-03-21
          CEP/COS

          Caution CEP/COS

          R1-CEP 2000-234 - Rev 01
          Withdrawn by Holder
          Leucine
          2008-03-07
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          31556
          R1-CEP 2000-234 - Rev 01
          Status
          Active
          Fees Paid
          Reviewed
          Withdrawn by Holder
           
          Filing Details
          L-LEUCINE
          Leucine
          Issue/Submission Date
          2017-03-21
          2008-03-07
          ASK
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          Nateglinide

          PDF Supplier PDF
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          USDMF

          Caution USDMF

          11155
          Inactive
          A-4166
          1994-10-24
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Found JDMF

          217MF10298
          File stick bulk powder at 1-15-1 Ky...
          2005-06-30
          Written Confirmation

          Close WC

          Application Number
          11155
          217MF10298
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          A-4166
          File stick bulk powder at 1-15-1 Ky...
          Issue/Submission Date
          1994-10-24
          2005-06-30
          ASK
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          • FDA
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          Amino Acids Mixture

          PDF Supplier PDF
          URL Supplier Web Content
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          USDMF

          Found USDMF

          4555
          Active
          AMINO ACIDS
          1982-03-17
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          4555
          Status
          Active
          Fees Paid
          Reviewed
           
          Filing Details
          AMINO ACIDS
          Issue/Submission Date
          1982-03-17
          ASK
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          L-Alanine API

          PDF Supplier PDF
          URL Supplier Web Content
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          USDMF

          Close USDMF

          CEP/COS

          Found CEP/COS

          R1-CEP 2014-002 - Rev 00
          Valid
          Alanine, SA
          2020-10-20
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          R1-CEP 2014-002 - Rev 00
          Status
          Valid
           
          Filing Details
          Alanine, SA
          Issue/Submission Date
          2020-10-20
          ASK
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          • FDA
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          L-Arginine Hydrochloride API

          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 1998-120 - Rev 03
          Valid
          Arginine hydrochloride
          2014-10-10
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          R1-CEP 1998-120 - Rev 03
          Status
          Valid
           
          Filing Details
          Arginine hydrochloride
          Issue/Submission Date
          2014-10-10
          ASK
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          L-Glutamine

          PDF Supplier PDF
          URL Supplier Web Content
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          See Less

          USDMF

          Found USDMF

          19673
          Active
          L-GLUTAMINE
          2006-08-07
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          19673
          Status
          Active
          Fees Paid
          N/A
           
          Filing Details
          L-GLUTAMINE
          Issue/Submission Date
          2006-08-07
          ASK
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          • FDA
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          L-Histidine

          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 1998-107 - Rev 04
          Valid
          Histidine
          2018-06-22
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          R1-CEP 1998-107 - Rev 04
          Status
          Valid
           
          Filing Details
          Histidine
          Issue/Submission Date
          2018-06-22
          ASK
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          • FDA
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          L-Histidine

          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 1998-121 - Rev 04
          Valid
          Histidine Hydrochloride Monohydrate
          2018-06-22
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          R1-CEP 1998-121 - Rev 04
          Status
          Valid
           
          Filing Details
          Histidine Hydrochloride Monohydrate
          Issue/Submission Date
          2018-06-22
          ASK
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          L-Threonine

          PDF Supplier PDF
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          USDMF

          Close USDMF

          CEP/COS

          Found CEP/COS

          R1-CEP 2013-004 - Rev 01
          Valid
          Threonine, SA
          2021-03-12
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          R1-CEP 2013-004 - Rev 01
          Status
          Valid
           
          Filing Details
          Threonine, SA
          Issue/Submission Date
          2021-03-12
          ASK
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          • FDA
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          Lysine Acetate

          PDF Supplier PDF
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          See all info for this product

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          USDMF

          Caution USDMF

          31650
          Inactive
          L-LYSINE ACETATE
          2017-04-20
          CEP/COS

          Caution CEP/COS

          R1-CEP 2005-060 - Rev 01
          Withdrawn by Holder
          Lysine acetate
          2015-02-12
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          31650
          R1-CEP 2005-060 - Rev 01
          Status
          Inactive
          Fees Paid
          N/A
          Withdrawn by Holder
           
          Filing Details
          L-LYSINE ACETATE
          Lysine acetate
          Issue/Submission Date
          2017-04-20
          2015-02-12
          ASK
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          • FDA
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          Miconazole Nitrate

          PDF Supplier PDF
          URL Supplier Web Content
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          USDMF

          Found USDMF

          27904
          Active
          MICONAZOLE NITRATE
          2014-02-19
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          27904
          Status
          Active
          Fees Paid
          Reviewed
           
          Filing Details
          MICONAZOLE NITRATE
          Issue/Submission Date
          2014-02-19
          ASK
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          Nafamostat

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

          See Less

          USDMF

          Close USDMF

          CEP/COS

          Close CEP/COS

          Japanese DMF

          Found JDMF

          226MF10002
          Nafamostat mesylate -A at 1-15-1 Ky...
          2014-01-08
          Written Confirmation

          Close WC

          Application Number
          226MF10002
          Status
           
          Filing Details
          Nafamostat mesylate -A at 1-15-1 Ky...
          Issue/Submission Date
          2014-01-08
          ASK
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          Prazosin Hydrochloride

          PDF Supplier PDF
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          See Less

          USDMF

          Found USDMF

          7161
          Active
          PRAZOSIN HYDROCHLORIDE
          1987-09-25
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          7161
          Status
          Active
          Fees Paid
          N/A
           
          Filing Details
          PRAZOSIN HYDROCHLORIDE
          Issue/Submission Date
          1987-09-25
          ASK
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          Sodium Hydroxide

          PDF Supplier PDF
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          See Less

          USDMF

          Close USDMF

          CEP/COS

          Close CEP/COS

          Japanese DMF

          Found JDMF

          302MF10078
          Upacyclet sodium hydrate at 1-15-1 ...
          2020-07-06
          Written Confirmation

          Close WC

          Application Number
          302MF10078
          Status
           
          Filing Details
          Upacyclet sodium hydrate at 1-15-1 ...
          Issue/Submission Date
          2020-07-06
          ASK
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          • FDA
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          Trifluridine

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

          See Less

          USDMF

          Close USDMF

          CEP/COS

          Close CEP/COS

          Japanese DMF

          Found JDMF

          302MF10048
          Trifluridine at 1-15-1 Kyobashi, Ch...
          2020-04-17
          Written Confirmation

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          Application Number
          302MF10048
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          Trifluridine at 1-15-1 Kyobashi, Ch...
          Issue/Submission Date
          2020-04-17
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          Histidine Hydrochloride Monohydrate, SA

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          CEP 2023-213 - Rev 00
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          Histidine Hydrochloride Monohydrate...
          2024-03-04
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          Application Number
          CEP 2023-213 - Rev 00
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          Histidine Hydrochloride Monohydrate...
          Issue/Submission Date
          2024-03-04
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