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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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    Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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    About

    Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable operations, and innovation has driven their commitment to improving global healthcare access. With a state-of-the-art manufacturing facility inaugurated in 2004, Symbiotec has become a trusted provider in the industry. Their certifications including WHO-GMP, ISO, US FDA, and EU GMP showcase their dedication to quality and excellence. Over two decades, they've maintained their position through adaptability, efficiency, and competitive pricing.

    CONTACT DETAILS

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    Symbiotec Pharmalabindia-flag Flag
    Country
    Country
    India
    Address
    Address
    385, Pigdamber, Rau, Indore, MP, 453331
    Telephone
    Telephone
    +91 7316676405
    Client Email
    Email
    symbiotec@symbiotec.in
    Client Website
    Website
    https://www.symbiotec.in/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/symbiotec-pharmalab-pvt-ltd-/
    Twitter
    Twitter
    https://twitter.com/symbiotec_spl
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    CPhI Worldwide, Milan

    Booth #2A58

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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      https://www.pharmacompass.com/pdf/party/content/symbiotec-pharmalab-party-content-55158.pdf

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    API Product List 2024

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      https://www.pharmacompass.com/pdf/party/content/symbiotec-pharmalab-party-content-84164.pdf

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    Intermediates Product List 2024

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      https://www.pharmacompass.com/pdf/party/content/symbiotec-pharmalab-party-content-99152.pdf

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    Products Under Development 2024

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      https://www.pharmacompass.com/pdf/party/content/symbiotec-pharmalab-party-content-67774.pdf

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    GMP Certificate 2024

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      https://www.pharmacompass.com/pdf/party/content/symbiotec-pharmalab-party-content-98.pdf

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    Regulatory Filing

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      https://www.pharmacompass.com/pdf/party/content/symbiotec-pharmalab-party-content-12453.pdf

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    ALL APIs

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    01

    Clobetasol Propionate

    India

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

    arrow
    CPhI Worldwide, Milan
    Booth #2A58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-11

    Pay. Date : 2012-12-31

    DMF Number : 20821

    Submission : 2007-08-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-263 - Rev 02

    Issue Date : 2016-01-22

    Type : Chemical

    Substance Number : 2127

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10086

    Registrant's Address : 385/2, Pigdamber, Off. A. B. Road, Rau, Indore 453331 (M.P.) India

    Initial Date of Registration : 2017-04-25

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0006

    Start Marketing Date : 2017-12-13

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : GlaxoSmithKline Co., Ltd.

    Registration Date : 2021-11-10

    Registration Number : 20121126-93-E-103-07(A)

    Manufacturer Name : Symbiotec Pharmalab Pvt. Limited

    Manufacturer Address : 385/2 Gram Pigdamber, Near Hotel Mashal, Off AB Road, Rau, Indore-453 331 (MP) India

     VMF Others AUDIT
    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Betamethasone

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-10-13

    Pay. Date : 2014-04-29

    DMF Number : 25197

    Submission : 2011-08-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-285 - Rev 01

    Issue Date : 2017-11-23

    Type : Chemical

    Substance Number : 312

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0030

    Start Marketing Date : 2011-08-24

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Betamethasone Dipropionate

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-02

    Pay. Date : 2016-02-12

    DMF Number : 25798

    Submission : 2012-02-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-079 - Rev 00

    Issue Date : 2018-02-19

    Type : Chemical

    Substance Number : 809

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0028

    Start Marketing Date : 2011-08-24

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Betamethasone Valerate

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-01

    Pay. Date : 2014-04-29

    DMF Number : 22062

    Submission : 2008-10-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-307 - Rev 00

    Issue Date : 2016-04-08

    Type : Chemical

    Substance Number : 811

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0005

    Start Marketing Date : 2017-12-12

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Ethinyl Estradiol

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-04-20

    Pay. Date : 2020-03-24

    DMF Number : 26020

    Submission : 2012-05-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-029 - Rev 00

    Issue Date : 2021-10-06

    Type : Chemical

    Substance Number : 140

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-31

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0162

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0034

    Start Marketing Date : 2012-06-27

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Methylprednisolone Acetate

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24611

    Submission : 2011-02-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-063 - Rev 01

    Issue Date : 2021-05-12

    Type : Chemical

    Substance Number : 933

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0023

    Start Marketing Date : 2011-08-08

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Methylprednisolone Hemisuccinate

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-03

    Pay. Date : 2014-02-21

    DMF Number : 22904

    Submission : 2009-06-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-187 - Rev 04

    Issue Date : 2023-01-30

    Type : Chemical

    Substance Number : 1131

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0024

    Start Marketing Date : 2011-08-24

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Mometasone Furoate

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-01

    Pay. Date : 2014-04-29

    DMF Number : 20684

    Submission : 2007-07-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-194 - Rev 03

    Issue Date : 2022-08-26

    Type : Chemical

    Substance Number : 1449

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0002

    Start Marketing Date : 2017-12-12

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Prednisolone

    India

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24630

    Submission : 2011-02-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-194 - Rev 00

    Issue Date : 2022-06-23

    Type : Chemical

    Substance Number : 353

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0025

    Start Marketing Date : 2011-08-24

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Prednisolone Sodium Phosphate

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-10

    Pay. Date : 2016-05-27

    DMF Number : 23899

    Submission : 2010-06-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-149 - Rev 01

    Issue Date : 2022-02-15

    Type : Chemical

    Substance Number : 735

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0004

    Start Marketing Date : 2017-12-12

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

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    Place

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    KEY PRODUCTS

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    Services

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    API Manufacturing

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    Inspections and registrations

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    ABOUT THIS PAGE

    Contact Symbiotec Pharmalab and get a quotation

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

    Find a price of Clobetasol Propionate bulk with DMF, CEP, JDMF, WC offered by Symbiotec Pharmalab

    Find a price of Beclomethasone Dipropionate bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Betamethasone bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Betamethasone Dipropionate bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Betamethasone Valerate bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Drospirenone bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Estradiol bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Ethinyl Estradiol bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Hydrocortisone bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Hydrocortisone Acetate bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Methylprednisolone bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Methylprednisolone Acetate bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Methylprednisolone Hemisuccinate bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Mometasone Furoate bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Prednisolone bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Prednisolone Acetate bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Prednisolone Sodium Phosphate bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Testosterone bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Triamcinolone Acetonide bulk with DMF, CEP, WC offered by Symbiotec Pharmalab

    Find a price of Betamethasone bulk with DMF, WC offered by Symbiotec Pharmalab

    Find a price of Betamethasone Sodium Phosphate bulk with DMF, WC offered by Symbiotec Pharmalab

    Find a price of Clobetasone Butyrate bulk with CEP, JDMF offered by Symbiotec Pharmalab

    Find a price of Conjugated Estrogens bulk with DMF, WC offered by Symbiotec Pharmalab

    Find a price of Deflazacort bulk with DMF, WC offered by Symbiotec Pharmalab

    Find a price of Desogestrel bulk with DMF, WC offered by Symbiotec Pharmalab

    Find a price of Desoximetasone bulk with DMF, WC offered by Symbiotec Pharmalab

    Find a price of Dexamethasone bulk with DMF, WC offered by Symbiotec Pharmalab

    Find a price of Halobetasol bulk with DMF, WC offered by Symbiotec Pharmalab

    Find a price of Hydrocortisone bulk with DMF, WC offered by Symbiotec Pharmalab

    Find a price of Hydrocortisone Sodium Succinate bulk with CEP, WC offered by Symbiotec Pharmalab

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