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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by AMINO GmbH

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    AMINO GmbH
    Germany Flag
    Country
    Country
    Germany
    Address
    Address
    An der Zucker-Raffinerie 9 Frellstedt, 38373
    Telephone
    Telephone
    +49 5355 9100 0
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://amino.de/de/
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    • FDA
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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

    Close JDMF

    Written Confirmation

    Close WC

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

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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

    Close WC

    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

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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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    • FDA
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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

    Close WC

    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

    Close WC

    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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    • FDA
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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 1998-034 - Rev 02
    Valid
    Tyrosine
    2014-08-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4649
    R1-CEP 1998-034 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    L-TYROSINE
    Tyrosine
    Issue/Submission Date
    1982-07-16
    2014-08-12
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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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    • FDA
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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

    Close WC

    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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    • FDA
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    Betaine

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    USDMF

    Caution USDMF

    11069
    Inactive
    BETAINE, MONOHYDRATE
    1994-09-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10183
    Betaine anhydrous at An der Zucker-...
    2013-09-25
    Written Confirmation

    Close WC

    Application Number
    11069
    225MF10183
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BETAINE, MONOHYDRATE
    Betaine anhydrous at An der Zucker-...
    Issue/Submission Date
    1994-09-08
    2013-09-25
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    Ac-DL-Trp-OH

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-214 - Rev 00
    Valid
    N-Acetyltryptophan
    2023-07-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-214 - Rev 00
    Status
    Valid
     
    Filing Details
    N-Acetyltryptophan
    Issue/Submission Date
    2023-07-03
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    Asparagine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-229 - Rev 01
    Valid
    Asparagine monohydrate
    2023-03-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-229 - Rev 01
    Status
    Valid
     
    Filing Details
    Asparagine monohydrate
    Issue/Submission Date
    2023-03-08
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    Betaine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    11079
    Active
    BETAINE
    1994-09-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11079
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BETAINE
    Issue/Submission Date
    1994-09-08
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    Betaine

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    USDMF

    Found USDMF

    31655
    Active
    BETAINE PHARMACEUTICAL GRADE
    2017-03-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31655
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BETAINE PHARMACEUTICAL GRADE
    Issue/Submission Date
    2017-03-28
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    • FDA
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    Glycine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-179 - Rev 01
    Valid
    Glycine
    2022-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-179 - Rev 01
    Status
    Valid
     
    Filing Details
    Glycine
    Issue/Submission Date
    2022-07-08
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    L-Alanine API

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-157 - Rev 01
    Valid
    Alanine
    2023-05-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-157 - Rev 01
    Status
    Valid
     
    Filing Details
    Alanine
    Issue/Submission Date
    2023-05-31
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    L-Arginine Hydrochloride API

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-188 - Rev 00
    Valid
    Arginine
    2022-05-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-188 - Rev 00
    Status
    Valid
     
    Filing Details
    Arginine
    Issue/Submission Date
    2022-05-19
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    L-Glutamic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-279 - Rev 00
    Valid
    Glutamic Acid
    2021-05-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-279 - Rev 00
    Status
    Valid
     
    Filing Details
    Glutamic Acid
    Issue/Submission Date
    2021-05-18
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    L-Leucine API

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-088 - Rev 00
    Valid
    Leucine, From feathers
    2019-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2014-088 - Rev 00
    Status
    Valid
     
    Filing Details
    Leucine, From feathers
    Issue/Submission Date
    2019-12-06
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    L-Methionine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    39084
    Active
    L-METHIONINE
    2023-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39084
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    L-METHIONINE
    Issue/Submission Date
    2023-11-30
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    L-Tyrosine API

    PDF Supplier PDF
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    USDMF

    Close USDMF

    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
    R1-CEP 2016-157 - Rev 00
    Status
    Valid
     
    Filing Details
    Tyrosine, Derived from fermentation
    Issue/Submission Date
    2023-01-12
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    Lysine Acetate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-042 - Rev 01
    Valid
    Lysine acetate
    2023-08-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-042 - Rev 01
    Status
    Valid
     
    Filing Details
    Lysine acetate
    Issue/Submission Date
    2023-08-25
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    Methionine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-005 - Rev 00
    Valid
    Methionine
    2021-12-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-005 - Rev 00
    Status
    Valid
     
    Filing Details
    Methionine
    Issue/Submission Date
    2021-12-07
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    N-Acetyl-L-Tyrosine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12721
    Active
    N-ACETYL-L-TYROSINE
    1997-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12721
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    N-ACETYL-L-TYROSINE
    Issue/Submission Date
    1997-10-29
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    N-Acetyltyrosine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-019 - Rev 00
    Valid
    N-Acetyltyrosine
    2019-04-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-019 - Rev 00
    Status
    Valid
     
    Filing Details
    N-Acetyltyrosine
    Issue/Submission Date
    2019-04-05
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    Serine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-315 - Rev 03
    Valid
    Serine
    2020-10-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-315 - Rev 03
    Status
    Valid
     
    Filing Details
    Serine
    Issue/Submission Date
    2020-10-26
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    • FDA
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    Betaine Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    7739
    Inactive
    BETAINE HCl
    1988-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7739
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BETAINE HCl
    Issue/Submission Date
    1988-10-18
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