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

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    01 Ac-DL-Trp-OH (1)

    02 Asparagine (1)

    03 Asparagine, L- (1)

    04 Aspartic Acid API (1)

    05 Betaine (3)

    06 Betaine Hydrochloride (1)

    07 Cystine (1)

    08 Enkephalin, Methionine (1)

    09 Glycine (1)

    10 Isoleucine (2)

    11 L-Alanine API (1)

    12 L-Arginine Hydrochloride API (1)

    13 L-Glutamic Acid (1)

    14 L-Glutamine (1)

    15 L-Histidine (1)

    16 L-Leucine API (3)

    17 L-Methionine (1)

    18 L-Threonine (1)

    19 L-Tyrosine API (2)

    20 L-VALINE (1)

    21 Lysine Acetate (1)

    22 Malic Acid (1)

    23 Methionine (1)

    24 N-Acetyl-L-Tyrosine (1)

    25 N-Acetyltyrosine (1)

    26 Phenylalanine (1)

    27 Serine (1)

    28 Tryptophan (1)

    filter

    01 Active (14)

    02 Inactive (2)

    03 Blank (18)

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    01 Valid (22)

    02 Withdrawn by Holder (1)

    03 Blank (11)

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    01 225MF10183 (1)

    02 Blank (33)

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    01 Blank (34)

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    Aspartic Acid API

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    USDMF

    Found USDMF

    34525
    Active
    L-ASPARTIC ACID
    2020-01-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-329 - Rev 03
    Valid
    Aspartic Acid
    2023-06-27
    Japanese DMF

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    Application Number
    34525
    R1-CEP 2008-329 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-ASPARTIC ACID
    Aspartic Acid
    Issue/Submission Date
    2020-01-27
    2023-06-27
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    Isoleucine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    4041
    Active
    L-ISOLEUCINE
    1980-10-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-228 - Rev 03
    Valid
    Isoleucine, From Fermentation
    2021-06-17
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    4041
    R1-CEP 2004-228 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-ISOLEUCINE
    Isoleucine, From Fermentation
    Issue/Submission Date
    1980-10-22
    2021-06-17
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    L-Histidine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    39086
    Active
    L-HISTIDINE
    2023-11-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-114 - Rev 00
    Valid
    Histidine
    2022-11-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39086
    R1-CEP 2016-114 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-HISTIDINE
    Histidine
    Issue/Submission Date
    2023-11-30
    2022-11-22
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    L-Leucine API

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    USDMF

    Found USDMF

    3828
    Active
    L-LEUCINE
    1980-06-11
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-011 - Rev 04
    Valid
    Leucine
    2013-11-13
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    3828
    R1-CEP 1997-011 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-LEUCINE
    Leucine
    Issue/Submission Date
    1980-06-11
    2013-11-13
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    L-Leucine API

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    USDMF

    Found USDMF

    31258
    Active
    L-LEUCINE FROM FERMENTATION
    2016-12-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-156 - Rev 00
    Valid
    Leucine, Obtained from fermentation
    2021-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31258
    R1-CEP 2014-156 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-LEUCINE FROM FERMENTATION
    Leucine, Obtained from fermentation
    Issue/Submission Date
    2016-12-14
    2021-12-20
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    L-Threonine

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    USDMF

    Found USDMF

    34526
    Active
    L-THREONINE
    2020-03-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-277 - Rev 03
    Valid
    Threonine
    2023-08-25
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    34526
    R1-CEP 2004-277 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-THREONINE
    Threonine
    Issue/Submission Date
    2020-03-27
    2023-08-25
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    L-Tyrosine API

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    USDMF

    Found USDMF

    4649
    Active
    L-TYROSINE
    1982-07-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-157 - Rev 00
    Valid
    Tyrosine, Derived from fermentation
    2023-01-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4649
    R1-CEP 2016-157 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-TYROSINE
    Tyrosine, Derived from fermentation
    Issue/Submission Date
    1982-07-16
    2023-01-12
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    L-VALINE

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    USDMF

    Found USDMF

    12720
    Active
    L-VALINE
    1997-10-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-137 - Rev 00
    Valid
    Valine
    2022-02-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12720
    R1-CEP 2016-137 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-VALINE
    Valine
    Issue/Submission Date
    1997-10-29
    2022-02-25
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    Phenylalanine

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    USDMF

    Found USDMF

    4033
    Active
    L-PHENYLALANINE
    1980-10-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-160 - Rev 01
    Valid
    Phenylalanine
    2014-08-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4033
    R1-CEP 2006-160 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-PHENYLALANINE
    Phenylalanine
    Issue/Submission Date
    1980-10-22
    2014-08-12
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    Tryptophan

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    USDMF

    Found USDMF

    8282
    Active
    L-TRYPTOPHAN
    1989-10-24
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-050 - Rev 06
    Valid
    Tryptophan
    2014-09-18
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    8282
    R1-CEP 1999-050 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-TRYPTOPHAN
    Tryptophan
    Issue/Submission Date
    1989-10-24
    2014-09-18
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