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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Symbiotec Pharmalab to the U.S. FDA. Original Data : FDA Website

    Client Virtual Booth

    SYMBIOTEC PHARMALAB

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

    VIDEO(s)

    DIGITAL CONTENT

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • 16-Alpha-Hydroxy Prednisolone

    • Beclomethasone Dipropionate

    • Betamethasone

    • Betamethasone Acetate

    • Betamethasone Benzoate

    • Betamethasone Butyrate Propionate

    • Betamethasone Dipropionate

    • Betamethasone Sodium Phosphate

    • Betamethasone Valerate

    • Clascoterone

    • Clobetasol Butyrate

    • Clobetasol Propionate

    • Conjugated Estrogens

    • Deflazacort

    • Desoximetasone

    • Dexamethasone

    • Dexamethasone 9,11-Epoxide

    • Dexamethasone Acetate

    • Dexamethasone Sodium Phosphate

    • DHA

    • Estradiol

    • Estradiol Acetate

    • Estradiol Benzoate

    • Estradiol Cypionate

    • Estradiol Enanthate

    • Estradiol Valerate

    • Estrone

    • Ethinyl Estradiol

    • Flumethasone

    • Flumethasone Pivalate

    • Fluorometholone

    • Fluorometholone Acetate

    • Hydroxyprogesterone Caproate

    • Methylprednisolone Acetate

    • Methylprednisolone Hemisuccinate

    • Methylprednisolone Sodium Succinate

    • Mometasone Furoate

    • Norethisterone

    • Norethisterone Acetate

    • Norethisterone Enanthate

    • Prasterone

    • Prasterone Acetate

    • Prednisolone

    • Prednisolone Acetate

    • Prednisolone Sodium Metasulfobenzoate

    • Prednisolone Sodium Phosphate

    • Progesterone

    • Serratiopeptidase

    • Teicoplanin

    • Testosterone

    • Testosterone Acetate

    • Testosterone Cypionate

    • Testosterone Decanoate

    • Testosterone Dodecanoate

    • Testosterone Enanthate

    • Testosterone Isocaproate

    • Testosterone Phenylpropionate

    • Testosterone Propionate

    • Testosterone Undecanoate

    INTERMEDIATES

    SERVICES

    INSPECTIONS & REGISTRATIONS

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    16A-HYDROXY PREDNISOLONE (INTERMEDI...

    PDF Supplier PDF
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    SYMBIOTEC PHARMALAB P...
    Active
    29224
    N/A
    2015-03-30
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    17-a HYDROXYPROGESTERONE (INTERMEDI...

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    SYMBIOTEC PHARMALAB P...
    Active
    29030
    N/A
    2015-01-20
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    BECLOMETHASONE DIPROPIONATE USP (MI...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CA
    SYMBIOTEC PHARMALAB P...
    Active
    28137
    N/A
    2014-03-20
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    BETAMETHASONE ACETATE USP

    PDF Supplier PDF
    URL Supplier Web Content
    SYMBIOTEC PHARMALAB P...
    Active
    36086
    Complete
    2023-10-25
    2023-10-05
    2022-07-21
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    BETAMETHASONE DIPROPIONATE

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    URL Supplier Web Content
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    SYMBIOTEC PHARMALAB P...
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    25798
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    2016-06-02
    2016-02-12
    2012-02-16
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    BETAMETHASONE SODIUM PHOSPHATE USP

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    URL Supplier Web Content
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    SYMBIOTEC PHARMALAB P...
    Active
    37466
    Complete
    2023-10-25
    2023-10-03
    2022-09-09
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    BETAMETHASONE VALERATE, USP (MICRON...

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    SYMBIOTEC PHARMALAB P...
    Active
    22062
    Complete
    2014-05-01
    2014-04-29
    2008-10-07
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    BETAMETHASONE, USP (MICRONIZED)

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    SYMBIOTEC PHARMALAB P...
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    25197
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    2015-10-13
    2014-04-29
    2011-08-10
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    CLOBETASOL PROPIONATE USP

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    Other DMF TW, RU, BR, SA, CA
    SYMBIOTEC PHARMALAB P...
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    20821
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    2013-04-11
    2012-12-31
    2007-08-29
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    DEFLAZACORT MICRONIZED

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    SYMBIOTEC PHARMALAB P...
    Active
    24691
    Complete
    2021-11-05
    2021-11-02
    2011-03-02
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    DEHYDROEPIANDROSTERONE (INTERMEDIAT...

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    SYMBIOTEC PHARMALAB P...
    Active
    29004
    N/A
    2015-01-12
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    DESOGESTREL EP/BP, MICRONIZED

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    SYMBIOTEC PHARMALAB P...
    Active
    28124
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    2014-03-17
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    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    DESOXIMETASONE USP (MICRONIZED)

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    SYMBIOTEC PHARMALAB P...
    Active
    22400
    Complete
    2013-07-23
    2012-12-31
    2009-01-12
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    DEXAMETHASONE USP

    PDF Supplier PDF
    URL Supplier Web Content
    SYMBIOTEC PHARMALAB P...
    Active
    38162
    Complete
    2023-10-26
    2023-10-03
    2023-03-29
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    DROSPIRENONE USP

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    URL Supplier Web Content
    Other DMF RU, BR
    SYMBIOTEC PHARMALAB P...
    Active
    32885
    N/A
    2018-08-30
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    ESTERIFIED ESTROGENS USP

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    SYMBIOTEC PHARMALAB P...
    Active
    27920
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    2014-02-19
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    ESTRADIOL HEMIHYDRATE USP

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    SYMBIOTEC PHARMALAB P...
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    34147
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    2020-04-20
    2020-03-23
    2019-09-11
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    ETHINYL ESTRADIOL, USP (MICRONIZED)

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    SYMBIOTEC PHARMALAB P...
    Active
    26020
    Complete
    2020-04-20
    2020-03-24
    2012-05-02
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    FLUMETHASONE

    PDF Supplier PDF
    URL Supplier Web Content
    SYMBIOTEC PHARMALAB P...
    Active
    25547
    Complete
    2014-11-17
    2013-11-01
    2011-12-01
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    HALOBETASOL PROPIONATE

    PDF Supplier PDF
    URL Supplier Web Content
    SYMBIOTEC PHARMALAB P...
    Active
    19402
    Complete
    2016-02-11
    2015-09-28
    2006-04-20
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    HYDROCORTISONE ACETATE USP

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF RU
    SYMBIOTEC PHARMALAB P...
    Active
    30820
    Complete
    2016-12-15
    2016-10-27
    2016-08-05
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    HYDROCORTISONE HEMISUCCINATE USP

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    URL Supplier Web Content
    Other DMF EU, CA, TW, SA, BR
    SYMBIOTEC PHARMALAB P...
    Active
    29221
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    2016-02-09
    2015-06-09
    2015-03-30
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    HYDROCORTISONE USP

    PDF Supplier PDF
    URL Supplier Web Content
    SYMBIOTEC PHARMALAB P...
    Active
    31349
    Complete
    2019-12-27
    2019-12-03
    2017-01-12
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    HYDROXYPROGESTERONE CAPROATE USP

    PDF Supplier PDF
    URL Supplier Web Content
    SYMBIOTEC PHARMALAB P...
    Active
    30747
    Complete
    2017-06-16
    2017-01-30
    2016-07-19
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    LEVONORGESTREL EP/USP, MICRONIZED

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    Other DMF ODMF
    SYMBIOTEC PHARMALAB P...
    Active
    27867
    Complete
    2014-06-23
    2014-01-23
    2014-01-27
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    METHYLPREDNISOLONE ACETATE USP

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    URL Supplier Web Content
    SYMBIOTEC PHARMALAB P...
    Active
    24611
    N/A
    2011-02-03
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    METHYLPREDNISOLONE HEMISUCCINATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF RU
    SYMBIOTEC PHARMALAB P...
    Active
    22904
    Complete
    2014-03-03
    2014-02-21
    2009-06-29
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    METHYLPREDNISOLONE USP (PROCESS 2)

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    SYMBIOTEC PHARMALAB P...
    Active
    34637
    N/A
    2020-11-05
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    METHYLPREDNISOLONE, USP (MICRONIZED...

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    SYMBIOTEC PHARMALAB P...
    Active
    27783
    Complete
    2014-07-21
    2013-12-17
    2013-11-25
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    MOMETASONE FUROATE MONOHYDRATE

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    SYMBIOTEC PHARMALAB P...
    Active
    25448
    N/A
    2011-10-31
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    MOMETASONE FUROATE USP (MICRONISED)

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    SYMBIOTEC PHARMALAB P...
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    20684
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    2014-05-01
    2014-04-29
    2007-07-12
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    PREDNISOLONE ACETATE USP

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    SYMBIOTEC PHARMALAB P...
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    32728
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    2020-05-19
    2020-04-13
    2018-06-04
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    • FDA
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    PREDNISOLONE HEMI SUCCINATE

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    SYMBIOTEC PHARMALAB P...
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    24630
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    2011-02-11
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    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    • FDA
    • EDQM
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    PREDNISOLONE SODIUM PHOSPHATE USP

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    SYMBIOTEC PHARMALAB P...
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    23899
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    2016-06-10
    2016-05-27
    2010-06-18
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    PREDNISOLONE USP

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    SYMBIOTEC PHARMALAB P...
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    34505
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    2021-05-06
    2021-04-09
    2020-02-21
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    PROGESTERONE USP

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    SYMBIOTEC PHARMALAB P...
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    32709
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    2019-09-11
    2019-06-10
    2018-04-03
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    TESTOSTERONE CYPIONATE USP

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    SYMBIOTEC PHARMALAB P...
    Active
    29023
    Complete
    2015-06-30
    2015-05-15
    2015-01-20
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    TESTOSTERONE ENANTHATE, USP

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    SYMBIOTEC PHARMALAB P...
    Active
    26166
    Complete
    2018-09-26
    2018-04-17
    2012-06-19
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    TESTOSTERONE PROPIONATE, USP (MICRO...

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    SYMBIOTEC PHARMALAB P...
    Active
    25535
    N/A
    2011-11-28
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    TESTOSTERONE UNDECANOATE

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    Other DMF TW, BR
    SYMBIOTEC PHARMALAB P...
    Active
    25534
    Complete
    2023-11-02
    2023-10-03
    2011-11-28
    II
    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    TESTOSTERONE USP (MICRONIZED)

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    SYMBIOTEC PHARMALAB P...
    Active
    29869
    N/A
    2015-09-30
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    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    TRIAMCINOLONE ACETONIDE USP

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    SYMBIOTEC PHARMALAB P...
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    2013-03-15
    2013-02-28
    2008-01-23
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    Symbiotec Pharmalab

    CPhI Worldwide, Milan

    Booth #2A58

    envelop Contact Supplier

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    CPhI Worldwide, Milan

    Booth #2A58

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