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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Royal Dsm

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    01 Amoxicillin Trihydrate (2)

    02 Ampicillin (1)

    03 Ampicillin Trihydrate (1)

    04 Aprotinin (2)

    05 Arachidonic Acid (1)

    06 Ascorbic Acid (6)

    07 Ascorbyl Palmitate (1)

    08 Benzylpenicillin Sodium (1)

    09 Beta Carotene (1)

    10 Biotin (1)

    11 Calcium Ascorbate (1)

    12 Calcium Pantothenate (1)

    13 Cannabidiol (1)

    14 Colesevelam Hydrochloride (1)

    15 Collagen (2)

    16 D-Panthenol (1)

    17 DHA (1)

    18 Dextromethorphan Hydrobromide (1)

    19 Ethyl Acetate (1)

    20 Fluocytosine (1)

    21 Folic Acid (1)

    22 Icosapent Ethyl (1)

    23 Neostigmine Methylsulfate (1)

    24 Niacin (1)

    25 Nicotinamide (1)

    26 Pantothenic Acid (1)

    27 Penicillin G Potassium (1)

    28 Pyridostigmine (1)

    29 Pyridoxine Hydrochloride (3)

    30 Riboflavin (1)

    31 Riboflavin 5 Phosphate Sodium (2)

    32 Silver Sulfadiazine (1)

    33 Sodium Ascorbate (1)

    34 Thiamine Hydrochloride (2)

    35 Thiamine Mononitrate (2)

    36 Vitamin A (3)

    37 Vitamin A Acetate (2)

    38 Vitamin A Palmitate (2)

    39 Vitamin B1 (1)

    40 Vitamin B12 (1)

    41 Vitamin D (1)

    42 Vitamin D3 (5)

    43 Vitamin E (2)

    44 Vitamin E Acetate (3)

    45 Vitamin K1 (1)

    46 Blank (2)

    filter

    01 Active (26)

    02 Blank (45)

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    01 Valid (31)

    02 Withdrawn by Holder (3)

    03 Blank (37)

    filter

    01 217MF11117 (1)

    02 217MF11118 (1)

    03 217MF11119 (1)

    04 217MF11120 (1)

    05 217MF11121 (1)

    06 217MF11122 (1)

    07 217MF11123 (1)

    08 217MF11283 (1)

    09 217MF11284 (1)

    10 217MF11285 (1)

    11 217MF11286 (1)

    12 217MF11287 (1)

    13 218MF10101 (1)

    14 218MF10102 (1)

    15 218MF10103 (1)

    16 218MF10107 (1)

    17 218MF10548 (1)

    18 218MF10551 (1)

    19 218MF10552 (1)

    20 218MF10553 (1)

    21 218MF11023 (1)

    22 219MF10043 (1)

    23 219MF10114 (1)

    24 219MF10115 (1)

    25 219MF10116 (1)

    26 219MF10117 (1)

    27 219MF10118 (1)

    28 219MF10120 (1)

    29 219MF10121 (1)

    30 221MF10043 (1)

    31 222MF10042 (1)

    32 223MF10101 (1)

    33 224MF10063 (1)

    34 225MF10007 (1)

    35 227MF10023 (1)

    36 228MF10181 (1)

    37 229MF10121 (1)

    38 230MF10050 (1)

    39 Blank (33)

    filter

    01 Blank (71)

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    Ascorbic Acid

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30618
    Active
    ASCORBIC ACID
    2016-07-05
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-078 - Rev 05
    Valid
    Ascorbic acid
    2022-09-29
    Japanese DMF

    Found JDMF

    225MF10007
    Ascorbic acid ultrafine powder Asco...
    2013-01-18
    Written Confirmation

    Close WC

    Application Number
    30618
    R1-CEP 1996-078 - Rev 05
    225MF10007
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ASCORBIC ACID
    Ascorbic acid
    Ascorbic acid ultrafine powder Asco...
    Issue/Submission Date
    2016-07-05
    2022-09-29
    2013-01-18
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    Biotin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30157
    Active
    BIOTIN
    2016-01-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-405 - Rev 05
    Valid
    Biotin
    2023-01-16
    Japanese DMF

    Found JDMF

    217MF11122
    Biotin Biotin at Wurmisweg 576, CH-...
    2005-12-05
    Written Confirmation

    Close WC

    Application Number
    30157
    R1-CEP 2001-405 - Rev 05
    217MF11122
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BIOTIN
    Biotin
    Biotin Biotin at Wurmisweg 576, CH-...
    Issue/Submission Date
    2016-01-13
    2023-01-16
    2005-12-05
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    D-Panthenol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30723
    Active
    DEXPANTHENOL
    2016-09-02
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-113 - Rev 03
    Valid
    Dexpanthenol
    2021-04-22
    Japanese DMF

    Found JDMF

    217MF11287
    Panthenol D-Panthenol at Wurmisweg ...
    2005-12-22
    Written Confirmation

    Close WC

    Application Number
    30723
    R1-CEP 1997-113 - Rev 03
    217MF11287
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DEXPANTHENOL
    Dexpanthenol
    Panthenol D-Panthenol at Wurmisweg ...
    Issue/Submission Date
    2016-09-02
    2021-04-22
    2005-12-22
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    Folic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30651
    Active
    FOLIC ACID
    2016-07-05
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-045 - Rev 06
    Valid
    Folic acid hydrate
    2023-08-10
    Japanese DMF

    Found JDMF

    218MF10102
    Folic Acid Folic Acid at Wurmisweg ...
    2006-01-30
    Written Confirmation

    Close WC

    Application Number
    30651
    R1-CEP 1996-045 - Rev 06
    218MF10102
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FOLIC ACID
    Folic acid hydrate
    Folic Acid Folic Acid at Wurmisweg ...
    Issue/Submission Date
    2016-07-05
    2023-08-10
    2006-01-30
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    Pyridoxine Hydrochloride

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    USDMF

    Found USDMF

    36386
    Active
    PYRIDOXINE HYDROCHLORIDE
    2021-12-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-027 - Rev 00
    Valid
    Pyridoxine hydrochloride
    2023-08-07
    Japanese DMF

    Found JDMF

    230MF10050
    Japanese Pharmacopoeia pyridoxine h...
    2018-04-04
    Written Confirmation

    Close WC

    Application Number
    36386
    R1-CEP 2017-027 - Rev 00
    230MF10050
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PYRIDOXINE HYDROCHLORIDE
    Pyridoxine hydrochloride
    Japanese Pharmacopoeia pyridoxine h...
    Issue/Submission Date
    2021-12-01
    2023-08-07
    2018-04-04
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    Thiamine Hydrochloride

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    USDMF

    Found USDMF

    30634
    Active
    THIAMINE HYDROCHLORIDE
    2016-06-29
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-131 - Rev 05
    Valid
    Thiamine hydrochloride
    2021-04-20
    Japanese DMF

    Found JDMF

    219MF10116
    Japanese Pharmacopoeia thiamine chl...
    2007-03-23
    Written Confirmation

    Close WC

    Application Number
    30634
    R1-CEP 1998-131 - Rev 05
    219MF10116
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    THIAMINE HYDROCHLORIDE
    Thiamine hydrochloride
    Japanese Pharmacopoeia thiamine chl...
    Issue/Submission Date
    2016-06-29
    2021-04-20
    2007-03-23
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    Vitamin D3

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    USDMF

    Found USDMF

    21048
    Active
    Cholecalciferol (Vitamin D3)
    2007-11-19
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-003 - Rev 00
    Valid
    Cholecalciferol concentrate (powder...
    2020-11-23
    Japanese DMF

    Found JDMF

    223MF10101
    Cholecalciferol Cholecalciferol / V...
    2011-07-11
    Written Confirmation

    Close WC

    Application Number
    21048
    R0-CEP 2019-003 - Rev 00
    223MF10101
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    Cholecalciferol (Vitamin D3)
    Cholecalciferol concentrate (powder...
    Cholecalciferol Cholecalciferol / V...
    Issue/Submission Date
    2007-11-19
    2020-11-23
    2011-07-11
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    Vitamin E Acetate

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    USDMF

    Found USDMF

    30673
    Active
    DL-ALPHA-TOCOPHERYL ACETATE
    2016-07-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-086 - Rev 00
    Valid
    alpha-Tocopheryl acetate concentrat...
    2021-03-04
    Japanese DMF

    Found JDMF

    219MF10115
    Japanese Pharmacopoeia tocopherol a...
    2007-03-23
    Written Confirmation

    Close WC

    Application Number
    30673
    R0-CEP 2019-086 - Rev 00
    219MF10115
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DL-ALPHA-TOCOPHERYL ACETATE
    alpha-Tocopheryl acetate concentrat...
    Japanese Pharmacopoeia tocopherol a...
    Issue/Submission Date
    2016-07-21
    2021-03-04
    2007-03-23
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    Vitamin K1

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24530
    Active
    PHYTOMENADIONE (VITAMIN K1)
    2011-01-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-085 - Rev 06
    Valid
    all-rac-Phytomenadione
    2022-01-24
    Japanese DMF

    Found JDMF

    218MF10101
    Phytonadione Phytonadione / Vitamin...
    2006-01-30
    Written Confirmation

    Close WC

    Application Number
    24530
    R1-CEP 2003-085 - Rev 06
    218MF10101
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PHYTOMENADIONE (VITAMIN K1)
    all-rac-Phytomenadione
    Phytonadione Phytonadione / Vitamin...
    Issue/Submission Date
    2011-01-05
    2022-01-24
    2006-01-30
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    Amoxicillin Trihydrate

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    NA Not Available For Sales
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    USDMF

    Found USDMF

    32157
    Active
    AMOXICILLIN TRIHYDRATE - PURIMOX®
    2017-12-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-178 - Rev 01
    Valid
    Amoxicillin trihydrate
    2020-08-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32157
    R0-CEP 2018-178 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMOXICILLIN TRIHYDRATE - PURIMOX®
    Amoxicillin trihydrate
    Issue/Submission Date
    2017-12-22
    2020-08-19
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