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    List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Axplora by EDQM. Original Data: EDQM Database

    Client Virtual Booth

    AXPLORA

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

    VIDEO(s)

    DIGITAL CONTENT

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • Acetylcysteine

    • Balsalazide Disodium

    • Beclomethasone Dipropionate

    • Carbocisteine

    • Carbocysteine Lysine

    • Lysine

    • Lysine Acetate

    • Lysine Hydrochloride

    • Mesalazine

    • Methylene Blue

    • Olaparib

    • Propafenone Hydrochloride

    • Triamcinolone

    • Triamcinolone Acetonide

    • Triamcinolone Diacetate

    • Triamcinolone Hexacetonide

    • Ursodeoxycholic Acid

    • Zavegepant HCl

    INTERMEDIATES

    SERVICES

    Key Products KEY SERVICES

    • Complex API Development Services

    • CDMO for Small Molecule APIs

    • API Custom Synthesis

    • Hazardous Chemistry

    • Flow Chemistry

    • Industrial Chromatography

    • Contract Development & Manufacturing for ADCs

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass
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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Acetylcysteine

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CA, BR, CN
    PharmaZell GmbH Raublin...
    Valid
    R2-CEP 1995-028 - Rev 04
    Chemical
    2020-12-15
    967
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Beclometasone dipropionate, Micronised, non-micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, SAU
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2001-315 - Rev 02
    Chemical
    2017-06-28
    654
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
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    Betamethasone dipropionate, Micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2003-232 - Rev 03
    Chemical
    2023-02-08
    809
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Betamethasone valerate, Micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2002-078 - Rev 03
    Chemical
    2021-03-22
    811
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
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    Budesonide, micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2000-051 - Rev 02
    Chemical
    2010-05-04
    1075
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Budesonide, Micronised, grades 21, 22 and 23

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2005-174 - Rev 01
    Chemical
    2017-07-25
    1075
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Busulfan

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2018-265 - Rev 00
    Chemical
    2020-03-24
    542
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Carbocisteine

    PDF Supplier PDF
    URL Supplier Web Content
    PharmaZell GmbH Raublin...
    Valid
    R1-CEP 1998-038 - Rev 05
    Chemical
    2017-05-19
    885
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Celecoxib

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CA
    PharmaZell GmbH Raublin...
    Valid
    CEP 2012-151 - Rev 02
    Chemical
    2023-11-09
    2591
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Chlormadinone acetate, Micronised (grade 21), non-micro...

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    CEP 2018-122 - Rev 03
    Chemical
    2023-09-07
    2702
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Cholic acid

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    PharmaZell GmbH Raublin...
    Valid
    CEP 2012-026 - Rev 06
    TSE
    2023-11-27
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Clobetasol propionate, Micronised, non-micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2011-135 - Rev 03
    Chemical
    2021-12-16
    2127
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Cyproterone acetate, Micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2018-270 - Rev 00
    Chemical
    2020-08-03
    1094
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Cysteine Hydrochloride Monohydrate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    PharmaZell GmbH Raublin...
    Valid
    R1-CEP 1997-014 - Rev 03
    Chemical
    2014-04-24
    895
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Cystine

    PDF Supplier PDF
    URL Supplier Web Content
    PharmaZell GmbH Raublin...
    Valid
    R1-CEP 2002-037 - Rev 02
    Chemical
    2017-01-23
    998
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Diltiazem hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Finorga S.A.S. Mourenx ...
    Valid
    R1-CEP 1998-115 - Rev 05
    Chemical
    2018-06-29
    1004
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Exemestane, micronized, non micronized

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2018-274 - Rev 00
    Chemical
    2020-12-18
    2766
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Fludrocortisone acetate, Micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2019-084 - Rev 00
    Chemical
    2020-11-18
    767
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Fluocinolone acetonide, Micronised, non-micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, SAU
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2004-103 - Rev 02
    Chemical
    2023-02-16
    494
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Fluticasone propionate, Micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    CEP 2008-117 - Rev 02
    Chemical
    2024-05-23
    1750
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Formoterol fumarate dihydrate, Micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2010-132 - Rev 01
    Chemical
    2017-08-11
    1724
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Fulvestrant

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2016-169 - Rev 00
    Chemical
    2023-02-22
    2443
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Hydrocortisone acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2020-135 - Rev 00
    Chemical
    2020-06-15
    334
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Hydrocortisone acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2018-171 - Rev 00
    Chemical
    2020-06-15
    334
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Hydrocortisone acetate, Micronised, sterile

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2021-456 - Rev 00
    Chemical
    2023-04-18
    334
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Indapamide

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    PharmaZell GmbH Raublin...
    Valid
    CEP 2007-138 - Rev 02
    Chemical
    2023-11-14
    1108
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Medroxyprogesterone acetate, Micronised (Type 21, Type ...

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2002-191 - Rev 03
    Chemical
    2023-07-03
    673
    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
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    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Megestrol acetate, Fine powder

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2002-154 - Rev 05
    Chemical
    2019-02-11
    1593
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Mesalazine

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CA, TW, BR, TH
    PharmaZell GmbH Raublin...
    Valid
    CEP 2003-203 - Rev 03
    Chemical
    2023-11-08
    1699
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Contact Supplier
    • FDA
    • EDQM
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Methylprednisolone acetate, Micronised, Sterile

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2021-429 - Rev 00
    Chemical
    2023-06-23
    933
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Contact Supplier
    • FDA
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Methylprednisolone hydrogen succinate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    Farmabios SpA Gropello ...
    Valid
    CEP 2023-235 - Rev 00
    Chemical
    2024-03-06
    1131
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Mometasone furoate, Micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2012-111 - Rev 00
    Chemical
    2018-08-27
    1449
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Mometasone furoate, Micronised, Alternative process

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF SAU
    Farmabios SpA Gropello ...
    Valid
    CEP 2018-297 - Rev 02
    Chemical
    2023-10-06
    1449
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Paclitaxel, Produced by a semi-synthetic process

    PDF Supplier PDF
    URL Supplier Web Content
    NA Not Available For Sales
    SERIPHARM S.A.S. Le Man...
    Valid
    R1-CEP 2008-327 - Rev 00
    Chemical
    2014-09-02
    1794
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Prednicarbate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2011-144 - Rev 02
    Chemical
    2023-01-05
    1467
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Prednisolone acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2019-109 - Rev 00
    Chemical
    2020-06-02
    734
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Prednisolone acetate, Micronised, sterile

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2017-286 - Rev 01
    Chemical
    2020-07-29
    734
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Propafenone hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CA, BR, TH, ID
    PharmaZell GmbH Raublin...
    Valid
    R1-CEP 2005-236 - Rev 03
    Chemical
    2018-06-08
    2103
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Salmeterol xinafoate, Micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2018-168 - Rev 00
    Chemical
    2020-06-12
    1765
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Triamcinolone acetonide, Micronised and non-micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R1-CEP 2000-075 - Rev 07
    Chemical
    2021-02-25
    533
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Triamcinolone acetonide, Micronised, sterile

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    CEP 2021-300 - Rev 01
    Chemical
    2024-05-03
    533
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Triamcinolone acetonide, Process 2, micronised and non-...

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2021-315 - Rev 00
    Chemical
    2021-12-21
    533
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Triamcinolone hexacetonide, Micronised, Non Micronised

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios SpA Gropello ...
    Valid
    R0-CEP 2018-282 - Rev 02
    Chemical
    2022-05-30
    867
    Axplora CB

    ChemOutsourcing

    Booth #58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Ursodeoxycholic acid

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, BR
    PharmaZell GmbH Raublin...
    Valid
    R1-CEP 2009-212 - Rev 00
    Chemical and TSE
    2015-10-26
    1275
    Axplora CB

    ChemOutsourcing

    Booth #58

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    Contact Supplier
    • FDA
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Ursodeoxycholic acid, UDCAe

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, BR
    PharmaZell GmbH Raublin...
    Valid
    R1-CEP 2012-277 - Rev 00
    Chemical and TSE
    2018-08-10
    1275
    Axplora CB

    ChemOutsourcing

    Booth #58

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