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

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    MINAKEM

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

    VIDEO(s)

    DIGITAL CONTENT

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • 1,1-Cyclobutane Dicarboxylic Acid

    • Budesonide

    • Cyclobutane Carboxaldehyde

    • Cyclopropyl Methyl Bromide

    • Cyclopropyl Methyl Chloride

    • Esomeprazole Magnesium

    • Esomeprazole Sodium

    • Fulvestrant

    • Ibrutinib

    • Methyl (1R,2S,5S)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxylate HCl

    • Propyl Gallate

    • Remifentanil

    • Vinblastine Sulfate

    • Vincristine Sulfate

    • Vinorelbine Tartrate

    INTERMEDIATES

    SERVICES

    Key Products KEY SERVICES

    • Continuous Flow Chemistry

    • Synthesis of Advanced Intermediates

    • Polymorph, Salt & Cocrystal Study

    • API Custom Synthesis

    • CDMO for High Potency APIs (HPAPIs)

    • HPAPI Contract Manufacturing

    EXCIPIENTS

    Key Products KEY EXCIPIENTS

    • Propyl Gallate GMP

    EXCIPIENTS BY INGREDIENTS

    EXCIPIENTS BY APPLICATIONS

    INSPECTIONS & REGISTRATIONS

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    Minakem RM
    Minakem
    France Flag
    Country
    Country
    France
    Address
    Address
    224 Avenue de la Dordogne, 59640 Dunkerque
    Telephone
    Telephone
    +33 320646830
    Client Email
    Email
    contact@minakem.com
    Client Website
    Website
    https://minakem.com/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/minakem
    Twitter
    Twitter
    https://twitter.com/Minafin_Group
    Contact Info
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    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Budesonide

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CA, IDN
    See all info for this product

    See Less

    USDMF

    Found USDMF

    28441
    Active
    BUDESONIDE MICRONIZED
    2014-06-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-190 - Rev 03
    Valid
    Budesonide, Micronised, non-microni...
    2020-06-09
    Japanese DMF

    Found JDMF

    301MF10045
    Budesonide at 224 avenue de la Dord...
    2019-08-20
    Written Confirmation

    Close WC

    Application Number
    28441
    R1-CEP 2010-190 - Rev 03
    301MF10045
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUDESONIDE MICRONIZED
    Budesonide, Micronised, non-microni...
    Budesonide at 224 avenue de la Dord...
    Issue/Submission Date
    2014-06-20
    2020-06-09
    2019-08-20
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Vinorelbine Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    14619
    Active
    VINORELBINE TARTRATE
    1999-12-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-342 - Rev 00
    Valid
    Vinorelbine tartrate
    2018-08-06
    Japanese DMF

    Found JDMF

    303MF10150
    Vinorelbine Tartrate at Rue Fonds J...
    2021-09-17
    Written Confirmation

    Close WC

    Application Number
    14619
    R1-CEP 2011-342 - Rev 00
    303MF10150
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VINORELBINE TARTRATE
    Vinorelbine tartrate
    Vinorelbine Tartrate at Rue Fonds J...
    Issue/Submission Date
    1999-12-13
    2018-08-06
    2021-09-17
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Esomeprazole Magnesium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28462
    Active
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
    2014-07-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-256 - Rev 02
    Valid
    Esomeprazole magnesium trihydrate, ...
    2021-06-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28462
    R1-CEP 2012-256 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
    Esomeprazole magnesium trihydrate, ...
    Issue/Submission Date
    2014-07-08
    2021-06-03
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Esomeprazole Magnesium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    34026
    Active
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE MI...
    2019-10-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-086 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate, M...
    2020-08-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34026
    R1-CEP 2015-086 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE MI...
    Esomeprazole magnesium dihydrate, M...
    Issue/Submission Date
    2019-10-04
    2020-08-31
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    envelop Contact Supplier

    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Solifenacin Succinate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30671
    Active
    SOLIFENACIN SUCCINATE
    2016-07-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-302 - Rev 00
    Valid
    Solifenacin succinate
    2023-08-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30671
    R1-CEP 2016-302 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin succinate
    Issue/Submission Date
    2016-07-21
    2023-08-28
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Vinblastine Sulfate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    5335
    Active
    VINBLASTINE SULFATE
    1984-04-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-065 - Rev 01
    Valid
    Vinblastine Sulfate, Process 2
    2023-07-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5335
    R0-CEP 2020-065 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VINBLASTINE SULFATE
    Vinblastine Sulfate, Process 2
    Issue/Submission Date
    1984-04-13
    2023-07-17
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Vincristine Sulfate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    4932
    Active
    VINCRISTINE SULFATE
    1983-06-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-048 - Rev 05
    Valid
    Vincristine sulfate
    2023-03-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4932
    R1-CEP 2004-048 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VINCRISTINE SULFATE
    Vincristine sulfate
    Issue/Submission Date
    1983-06-01
    2023-03-14
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    envelop Contact Supplier

    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Apixaban

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    30336
    Active
    APIXABAN
    2016-03-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30336
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APIXABAN
    Issue/Submission Date
    2016-03-14
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Azaperone

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-013 - Rev 00
    Valid
    Azaperone for veterinary use
    2019-09-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-013 - Rev 00
    Status
    Valid
     
    Filing Details
    Azaperone for veterinary use
    Issue/Submission Date
    2019-09-19
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    envelop Contact Supplier

    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Eslicarbazepine Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31791
    Active
    ESLICARBAZEPINE ACETATE
    2017-06-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31791
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ESLICARBAZEPINE ACETATE
    Issue/Submission Date
    2017-06-05
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Esmolol Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    4475
    Active
    ESMOLOL HYDROCHLORIDE
    1982-03-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4475
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ESMOLOL HYDROCHLORIDE
    Issue/Submission Date
    1982-03-12
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Fluorescein

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    18791
    Active
    FLUORESCEIN
    2005-09-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18791
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FLUORESCEIN
    Issue/Submission Date
    2005-09-16
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Fluvastatin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10010
    Fluvastatin sodium at 9321 Airlie S...
    2008-01-09
    Written Confirmation

    Close WC

    Application Number
    220MF10010
    Status
     
    Filing Details
    Fluvastatin sodium at 9321 Airlie S...
    Issue/Submission Date
    2008-01-09
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Lapatinib Ditosylate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    32266
    Active
    LAPATINIB DITOSYLATE
    2018-01-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32266
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LAPATINIB DITOSYLATE
    Issue/Submission Date
    2018-01-17
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Methazolamide

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    8676
    Active
    METHAZOLAMIDE
    1990-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8676
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METHAZOLAMIDE
    Issue/Submission Date
    1990-08-01
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Mirabegron

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    32929
    Active
    MIRABEGRON
    2018-09-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32929
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MIRABEGRON
    Issue/Submission Date
    2018-09-14
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Montelukast Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    16243
    Active
    MONTELUKAST SODIUM THIOL ACID
    2002-11-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16243
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MONTELUKAST SODIUM THIOL ACID
    Issue/Submission Date
    2002-11-15
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Pentamidine Isethionate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    6492
    Active
    PENTAMIDINE ISETHIONATE
    1986-07-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6492
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PENTAMIDINE ISETHIONATE
    Issue/Submission Date
    1986-07-23
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Pyrazinamide

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    15325
    Active
    PYRAZINAMIDE
    2001-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15325
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PYRAZINAMIDE
    Issue/Submission Date
    2001-02-28
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Remifentanil

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-323 - Rev 00
    Valid
    Remifentanil hydrochloride
    2022-03-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-323 - Rev 00
    Status
    Valid
     
    Filing Details
    Remifentanil hydrochloride
    Issue/Submission Date
    2022-03-14
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    envelop Contact Supplier

    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Rosuvastatin Calcium

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    29190
    Active
    ROSUVASTATIN CALCIUM
    2015-12-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29190
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ROSUVASTATIN CALCIUM
    Issue/Submission Date
    2015-12-03
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Sorafenib

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    32140
    Active
    SORAFENIB HEMITOSYLATE
    2017-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32140
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SORAFENIB HEMITOSYLATE
    Issue/Submission Date
    2017-12-20
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Succinylcholine Chloride

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    23224
    Active
    SUCCINYLCHOLINE CHLORIDE
    2009-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23224
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUCCINYLCHOLINE CHLORIDE
    Issue/Submission Date
    2009-10-29
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

    Tofacitinib Citrate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    33332
    Active
    TOFACITINIB CITRATE
    2018-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33332
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TOFACITINIB CITRATE
    Issue/Submission Date
    2018-12-21
    Minakem Delmar

    Swiss Biotech Day

    Not Confirmed

    envelop Contact Supplier
    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Vinblastine Sulfate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-073 - Rev 02
    Valid
    Vinblastine Sulfate
    2015-08-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-073 - Rev 02
    Status
    Valid
     
    Filing Details
    Vinblastine Sulfate
    Issue/Submission Date
    2015-08-04
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • Audit Compliance
    Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Vindesine Sulfate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10518
    Vindesine sulfate at Rue Fonds Jean...
    2006-05-18
    Written Confirmation

    Close WC

    Application Number
    218MF10518
    Status
     
    Filing Details
    Vindesine sulfate at Rue Fonds Jean...
    Issue/Submission Date
    2006-05-18
    Minakem Comapny Banner

    CPhI North America

    Booth #1210

    envelop Contact Supplier

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