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    01 Alpha Hydroxymethionine Calcium (1)

    02 Alpha-Ketovaline Calcium (1)

    03 Asparagine (1)

    04 Aspartic Acid API (1)

    05 Azelastine Hydrochloride (1)

    06 Chlorhexidine (1)

    07 Chlorhexidine Gluconate (1)

    08 DL-Valine API (1)

    09 Dimercaprol (1)

    10 Glycine (1)

    11 Hydrogen Peroxide (1)

    12 Isoleucine (1)

    13 L-Alanine API (2)

    14 L-Glutamic Acid (2)

    15 L-Glutamine (1)

    16 L-Leucine API (1)

    17 L-Lysine Hydrochloride (2)

    18 L-Methionine (1)

    19 L-Ornithine L-aspartate (1)

    20 L-Threonine (2)

    21 L-VALINE (1)

    22 Lisinopril (1)

    23 Lorazepam (1)

    24 Lormetazepam (1)

    25 Lysine (1)

    26 Lysine Acetate (1)

    27 Methionine (2)

    28 Phenylalanine (2)

    29 Proline (2)

    30 Serine (3)

    31 Tryptophan (1)

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    01 Active (14)

    02 Blank (26)

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    01 Valid (23)

    02 Blank (17)

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    01 217MF10600 (1)

    02 218MF10656 (1)

    03 218MF10657 (1)

    04 218MF10658 (1)

    05 218MF10659 (1)

    06 218MF10962 (1)

    07 218MF10964 (1)

    08 218MF10965 (1)

    09 218MF10966 (1)

    10 218MF10967 (1)

    11 218MF10975 (1)

    12 218MF10976 (1)

    13 218MF10977 (1)

    14 218MF10978 (1)

    15 220MF10094 (1)

    16 220MF10096 (1)

    17 220MF10113 (1)

    18 222MF10123 (1)

    19 222MF10179 (1)

    20 224MF10087 (1)

    21 225MF10189 (1)

    22 225MF10190 (1)

    23 226MF10122 (1)

    24 226MF10123 (1)

    25 227MF10148 (1)

    26 228MF10022 (1)

    27 231MF10069 (1)

    28 Blank (13)

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    01 Blank (40)

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    Aspartic Acid API

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19766
    Active
    L-ASPARTIC ACID
    2006-08-28
    CEP/COS

    Found CEP/COS

    CEP 2004-216 - Rev 04
    Valid
    Aspartic Acid
    2023-11-14
    Japanese DMF

    Found JDMF

    218MF10976
    L- aspartic acid L-Aspartic acid at...
    2006-12-01
    Written Confirmation

    Close WC

    Application Number
    19766
    CEP 2004-216 - Rev 04
    218MF10976
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-ASPARTIC ACID
    Aspartic Acid
    L- aspartic acid L-Aspartic acid at...
    Issue/Submission Date
    2006-08-28
    2023-11-14
    2006-12-01
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    Chlorhexidine Gluconate

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    USDMF

    Found USDMF

    8379
    Active
    CHLORHEXIDINE DIGLUCONATE
    1990-01-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-343 - Rev 05
    Valid
    Chlorhexidine digluconate solution
    2020-08-31
    Japanese DMF

    Found JDMF

    217MF10600
    Chlorhexidine gluconate solution 20...
    2005-09-14
    Written Confirmation

    Close WC

    Application Number
    8379
    R1-CEP 2001-343 - Rev 05
    217MF10600
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CHLORHEXIDINE DIGLUCONATE
    Chlorhexidine digluconate solution
    Chlorhexidine gluconate solution 20...
    Issue/Submission Date
    1990-01-19
    2020-08-31
    2005-09-14
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    Glycine

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    USDMF

    Found USDMF

    30393
    Active
    GLYCINE
    2016-03-02
    CEP/COS

    Found CEP/COS

    CEP 2008-099 - Rev 05
    Valid
    Glycine
    2023-10-03
    Japanese DMF

    Found JDMF

    220MF10113
    Glycine Glycine at No. 10 Wenjiang ...
    2008-04-21
    Written Confirmation

    Close WC

    Application Number
    30393
    CEP 2008-099 - Rev 05
    220MF10113
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GLYCINE
    Glycine
    Glycine Glycine at No. 10 Wenjiang ...
    Issue/Submission Date
    2016-03-02
    2023-10-03
    2008-04-21
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    L-Alanine API

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    USDMF

    Found USDMF

    19769
    Active
    L-ALANINE
    2006-08-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-086 - Rev 07
    Valid
    Alanine
    2023-08-24
    Japanese DMF

    Found JDMF

    218MF10975
    L- alanine L-Alanine at No. 10 Wenj...
    2006-12-01
    Written Confirmation

    Close WC

    Application Number
    19769
    R1-CEP 2004-086 - Rev 07
    218MF10975
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-ALANINE
    Alanine
    L- alanine L-Alanine at No. 10 Wenj...
    Issue/Submission Date
    2006-08-28
    2023-08-24
    2006-12-01
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    Lisinopril

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    USDMF

    Found USDMF

    19138
    Active
    LISINOPRIL DIHYDRATE
    2006-01-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-011 - Rev 07
    Valid
    Lisinopril dihydrate
    2020-12-09
    Japanese DMF

    Found JDMF

    224MF10087
    Lisinopril dihydrate Lisinopril Dih...
    2012-04-13
    Written Confirmation

    Close WC

    Application Number
    19138
    R1-CEP 2004-011 - Rev 07
    224MF10087
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LISINOPRIL DIHYDRATE
    Lisinopril dihydrate
    Lisinopril dihydrate Lisinopril Dih...
    Issue/Submission Date
    2006-01-26
    2020-12-09
    2012-04-13
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    Proline

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    USDMF

    Found USDMF

    26400
    Active
    L-PROLINE
    2012-09-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-019 - Rev 02
    Valid
    Proline, Fermentative origin
    2022-04-06
    Japanese DMF

    Found JDMF

    218MF10964
    L- proline L-Proline at 33, Rue de ...
    2006-12-01
    Written Confirmation

    Close WC

    Application Number
    26400
    R1-CEP 2007-019 - Rev 02
    218MF10964
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L-PROLINE
    Proline, Fermentative origin
    L- proline L-Proline at 33, Rue de ...
    Issue/Submission Date
    2012-09-03
    2022-04-06
    2006-12-01
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    Serine

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    USDMF

    Found USDMF

    37552
    Active
    L - SERINE
    2022-10-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-020 - Rev 01
    Valid
    Serine, Bio-enzymatic synthesis pro...
    2014-03-21
    Japanese DMF

    Found JDMF

    227MF10148
    L- serine L-Serine at No. 10 Wenjia...
    2015-05-26
    Written Confirmation

    Close WC

    Application Number
    37552
    R1-CEP 2007-020 - Rev 01
    227MF10148
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    L - SERINE
    Serine, Bio-enzymatic synthesis pro...
    L- serine L-Serine at No. 10 Wenjia...
    Issue/Submission Date
    2022-10-13
    2014-03-21
    2015-05-26
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    Azelastine Hydrochloride

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    USDMF

    Found USDMF

    15440
    Active
    AZELASTINE HYDROCHLORIDE
    2001-05-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-333 - Rev 04
    Valid
    Azelastine hydrochloride
    2021-01-13
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    15440
    R1-CEP 2009-333 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AZELASTINE HYDROCHLORIDE
    Azelastine hydrochloride
    Issue/Submission Date
    2001-05-15
    2021-01-13
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    Dimercaprol

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-330 - Rev 02
    Valid
    Dimercaprol
    2020-11-09
    Japanese DMF

    Found JDMF

    222MF10123
    Dimercaprol Dimercaprol at Rellingh...
    2010-04-05
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-330 - Rev 02
    222MF10123
    Status
    Valid
     
    Filing Details
    Dimercaprol
    Dimercaprol Dimercaprol at Rellingh...
    Issue/Submission Date
    2020-11-09
    2010-04-05
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    Isoleucine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2008-098 - Rev 02
    Valid
    Isoleucine
    2023-10-18
    Japanese DMF

    Found JDMF

    218MF10978
    L- isoleucine L-Isoleucine at No. 1...
    2006-12-01
    Written Confirmation

    Close WC

    Application Number
    CEP 2008-098 - Rev 02
    218MF10978
    Status
    Valid
     
    Filing Details
    Isoleucine
    L- isoleucine L-Isoleucine at No. 1...
    Issue/Submission Date
    2023-10-18
    2006-12-01
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