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    Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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    01 1Abrocitinib

    02 1Alcaftadine

    03 1Arginine Vasopressin

    04 1Aripiprazole

    05 1Ataluren

    06 1Avacopan

    07 1Avatrombopag Maleate

    08 1Azacitidine

    09 1Azathioprine

    10 1Bedaquiline

    11 1Belzutifan

    12 1Berotralstat Hydrochloride

    13 1Bexarotene

    14 1Bortezomib

    15 1Brinzolamide

    16 1Brivaracetam

    17 1Bromfenac Sodium

    18 1Busulfan

    19 1Cabergoline

    20 1Cabotegravir

    21 1Carfilzomib

    22 1Cetrorelix Acetate

    23 1Cevimeline Hydrochloride

    24 1Cinitapride Hydrogen Tartrate

    25 1Clofarabine

    26 1Colestipol

    27 1Crizotinib

    28 1Cyclophosphamide

    29 1Cysteamine Bitartrate

    30 1Cysteamine Hydrochloride

    31 1Dacarbazine

    32 3Degarelix Acetate

    33 1Deucravacitinib

    34 1Diflunisal

    35 1Dimetindene

    36 1Dofetilide

    37 1Dolutegravir Sodium

    38 1Elacestrant

    39 1Enasidenib

    40 1Ethacrynic Acid

    41 1Favipiravir

    42 1Felbamate

    43 2Ferric Carboxymaltose

    44 1Ferric Citrate

    45 1Ferric Derisomaltose

    46 1Ferric Maltol

    47 1Ferric Pyrophosphate Citrate

    48 1Ferumoxides

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    52 1Fluocytosine

    53 1Fluorescein

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    58 1Granisetron Hydrochloride

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    70 1Larotrectinib

    71 1Lenacapavir

    72 1Lenalidomide

    73 1Leuprolide Acetate

    74 1Linaclotide

    75 1Liraglutide

    76 1Lumacaftor

    77 1Lurbinectedin

    78 1Mafenide

    79 1Maralixibat

    80 1Maralixibat Chloride

    81 1Mavacamten

    82 1Methylene Blue

    83 1Methyltyrosine

    84 1Micafungin

    85 1Midostaurin

    86 1Miglustat

    87 1Mitapivat

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    94 1Octreotide Acetate

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    96 1Oseltamivir Phosphate

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    101 1Pentostatin

    102 1Perphenazine

    103 1Phenoxybenzamine HCl

    104 1Phentolamine Mesylate

    105 1Plerixafor

    106 1Pomalidomide

    107 2Ponatinib

    108 1Pralatrexate

    109 1Primaquine Diphosphate

    110 1Procarbazine Hydrochloride

    111 1Protriptyline

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    113 1Raltegravir Potassium

    114 1Regadenoson Monohydrate

    115 1Rilpivirine Hydrochloride

    116 1Riluzole

    117 1Ritlecitinib

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    120 1Safinamide Methanesulfonate

    121 1Selegiline Hydrochloride

    122 1Selenious Acid

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    125 1Sincalide

    126 1Sodium Nitroprusside

    127 1Sodium Zirconium Cyclosilicate

    128 1Sparsentan

    129 2Sugammadex Sodium

    130 1Sulfiram

    131 1Tecovirimat

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    134 1Tetrabenazine

    135 1Tirzepatide

    136 2Trabectedin

    137 1Triamterene

    138 1Trientine Hydrochloride

    139 1Trifluridine

    140 1Trilaciclib

    141 1Triptorelin Pamoate

    142 1Umifenovir

    143 1Ursodeoxycholic Acid

    144 1VANDETANIB

    145 1Vismodegib

    146 1Voriconazole

    147 1Vortioxetine Hydrobromide

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    01

    Bortezomib

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
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    Bortezomib

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BIO Partnering at JPM
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-22

    Pay. Date : 2013-09-20

    DMF Number : 22922

    Submission : 2009-06-30

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 231MF10057

    Registrant's Address : 49 Napoleon Ct. , Somerset, NJ 08873, USA

    Initial Date of Registration : 2019-02-25

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 14096-140

    Start Marketing Date : 2009-06-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    02

    Busulfan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
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    Busulfan

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BIO Partnering at JPM
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-06-10

    Pay. Date : 2015-05-27

    DMF Number : 23924

    Submission : 2010-08-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-270 - Rev 00

    Issue Date : 2023-05-17

    Type : Chemical

    Substance Number : 542

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    NDC Package Code : 14096-147

    Start Marketing Date : 2011-07-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Cevimeline Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Cevimeline Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BIO Partnering at JPM
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-09-12

    Pay. Date : 2024-08-24

    DMF Number : 40223

    Submission : 2024-07-23

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

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    04

    Miglustat

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
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    Miglustat

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BIO Partnering at JPM
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41867

    Submission : 2025-06-09

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    05

    Phentolamine Mesylate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Phentolamine Mesylate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BIO Partnering at JPM
    Not Confirmed
    • fda
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39948

    Submission : 2024-06-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    06

    Plerixafor

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Plerixafor

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40546

    Submission : 2024-10-04

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    07

    Trabectedin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Trabectedin

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-07-13

    Pay. Date : 2021-06-07

    DMF Number : 35828

    Submission : 2021-04-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42973-310

    Start Marketing Date : 2020-12-06

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    08

    Alcaftadine

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Alcaftadine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32382

    Submission : 2018-01-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Belzutifan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Belzutifan

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-07-01

    Pay. Date : 2025-05-27

    DMF Number : 41515

    Submission : 2025-05-06

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Bexarotene

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Bexarotene

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
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    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-08-07

    Pay. Date : 2015-07-29

    DMF Number : 23631

    Submission : 2010-04-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 14096-150

    Start Marketing Date : 2009-10-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Contact Apicore and get a quotation

    Apicore is a supplier offers 155 products (APIs, Excipients or Intermediates).

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