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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

    Symbiotech Pharmalab-PSE
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    J&J to invest $2 billion for new manufacturing facility in Carolina

    02 Oct 2024

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    02 Oct 2024

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    01 Oct 2024

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    01 116A-HYDROXY PREDNISOLONE (INTERMEDIATE)

    02 117-a HYDROXYPROGESTERONE (INTERMEDIATE)

    03 1BECLOMETHASONE DIPROPIONATE USP (MICRONIZED & NON-MICRONIZED)

    04 1BETAMETHASONE ACETATE USP

    05 1BETAMETHASONE DIPROPIONATE

    06 1BETAMETHASONE SODIUM PHOSPHATE USP

    07 1BETAMETHASONE VALERATE, USP (MICRONIZED)

    08 1BETAMETHASONE, USP (MICRONIZED)

    09 1CLOBETASOL PROPIONATE USP

    10 1DEFLAZACORT MICRONIZED

    11 1DEHYDROEPIANDROSTERONE (INTERMEDIATE)

    12 1DESOGESTREL EP/BP, MICRONIZED

    13 1DESOXIMETASONE USP (MICRONIZED)

    14 1DEXAMETHASONE USP

    15 1DROSPIRENONE USP

    16 1ESTERIFIED ESTROGENS USP

    17 1ESTRADIOL HEMIHYDRATE USP

    18 1ETHINYL ESTRADIOL, USP (MICRONIZED)

    19 1FLUMETHASONE

    20 1HALOBETASOL PROPIONATE

    21 1HYDROCORTISONE ACETATE USP

    22 1HYDROCORTISONE HEMISUCCINATE USP

    23 1HYDROCORTISONE USP

    24 1HYDROXYPROGESTERONE CAPROATE USP

    25 1LEVONORGESTREL EP/USP, MICRONIZED

    26 1METHYLPREDNISOLONE ACETATE USP

    27 1METHYLPREDNISOLONE HEMISUCCINATE

    28 1METHYLPREDNISOLONE USP (PROCESS 2)

    29 1METHYLPREDNISOLONE, USP (MICRONIZED)

    30 1MOMETASONE FUROATE MONOHYDRATE

    31 1MOMETASONE FUROATE USP (MICRONISED)

    32 1PREDNISOLONE ACETATE USP

    33 1PREDNISOLONE HEMI SUCCINATE

    34 1PREDNISOLONE SODIUM PHOSPHATE USP

    35 1PREDNISOLONE USP

    36 1PROGESTERONE USP

    37 1TESTOSTERONE CYPIONATE USP

    38 1TESTOSTERONE ENANTHATE, USP

    39 1TESTOSTERONE PROPIONATE, USP (MICRONIZED)

    40 1TESTOSTERONE UNDECANOATE

    41 1TESTOSTERONE USP (MICRONIZED)

    42 1TRIAMCINOLONE ACETONIDE USP

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    01

    16a-hydroxy Prednisolone (intermedia...

    India
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    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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    Symbiotec Pharmalab

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 29224

    Submission : 2015-03-30

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
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    02

    17-a Hydroxyprogesterone (intermedia...

    India
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    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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    Symbiotec Pharmalab

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 29030

    Submission : 2015-01-20

    Status : Active

    Type : II

    Symbiotec Pharmalab

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    Web Link

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    03

    Beclomethasone Dipropionate Usp (mic...

    India
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    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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    Symbiotec Pharmalab

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28137

    Submission : 2014-03-20

    Status : Active

    Type : II

    Symbiotec Pharmalab

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    04

    Betamethasone Acetate Usp

    India
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    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-10-25

    Pay. Date : 2023-10-05

    DMF Number : 36086

    Submission : 2022-07-21

    Status : Active

    Type : II

    Symbiotec Pharmalab

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    05

    Betamethasone Dipropionate

    India
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    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-06-02

    Pay. Date : 2016-02-12

    DMF Number : 25798

    Submission : 2012-02-16

    Status : Active

    Type : II

    Symbiotec Pharmalab

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    06

    Betamethasone Sodium Phosphate Usp

    India
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    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-10-25

    Pay. Date : 2023-10-03

    DMF Number : 37466

    Submission : 2022-09-09

    Status : Active

    Type : II

    Symbiotec Pharmalab

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    07

    Betamethasone Valerate, Usp (microni...

    India
    arrow
    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-05-01

    Pay. Date : 2014-04-29

    DMF Number : 22062

    Submission : 2008-10-07

    Status : Active

    Type : II

    Symbiotec Pharmalab

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    #PipelineProspector

    Market
    Place

    08

    Betamethasone, Usp (micronized)

    India
    arrow
    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-10-13

    Pay. Date : 2014-04-29

    DMF Number : 25197

    Submission : 2011-08-10

    Status : Active

    Type : II

    Symbiotec Pharmalab

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    Web Link

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    #PipelineProspector

    Market
    Place

    09

    Clobetasol Propionate Usp

    India
    arrow
    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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    Flag India
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    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-04-11

    Pay. Date : 2012-12-31

    DMF Number : 20821

    Submission : 2007-08-29

    Status : Active

    Type : II

    Symbiotec Pharmalab

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    Web Link

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    10

    Deflazacort Micronized

    India
    arrow
    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-11-05

    Pay. Date : 2021-11-02

    DMF Number : 24691

    Submission : 2011-03-02

    Status : Active

    Type : II

    Symbiotec Pharmalab

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    Contact Symbiotec Pharmalab and get a quotation

    Symbiotec Pharmalab is a supplier offers 127 products (APIs, Excipients or Intermediates).

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