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    List of Drug Master Files (DMF) of Difluprednate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Difluprednate

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    01 Axplora (1)

    02 ChemWerth Inc (1)

    03 Teva API (1)

    04 Steroid SpA (1)

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    01 DIFLUPREDNATE (3)

    02 DIFLUPREDNATE (MICRONIZED) (1)

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    01 Germany (1)

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    FARMABIOS SPA

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    • FDA
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    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.
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    DIFLUPREDNATE (MICRONIZED)

    PDF Supplier PDF
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    25228
    Active
    2011-08-23
    Complete
    2014-08-27
    2014-04-14
    II
    Axplora CB

    RDD 2024

    Not Confirmed

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    CHEMWERTH INC

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    • FDA
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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    DIFLUPREDNATE

    PDF Supplier PDF
    URL Supplier Web Content
    26378
    Active
    2013-07-22
    Complete
    2014-05-13
    2013-08-05
    II
    Chemwerth Compnay Banner

    CPhI North America

    Attending

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    TEVA PHARMACEUTICAL INDUSTRIES LTD

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    • FDA
    • EDQM
    Virtual BoothTeva API has over 350 products in its portfolio and is the leading international supplier of APIs.
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    Flag Israel
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    DIFLUPREDNATE

    PDF Supplier PDF
    URL Supplier Web Content
    19870
    Active
    2006-10-16
    Complete
    2015-10-26
    2015-10-21
    II
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    STEROID SPA

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    • EDQM
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    Flag Italy
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    DIFLUPREDNATE

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    32778
    Active
    2018-05-10
    N/A
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    Looking for 23674-86-4 / Difluprednate API manufacturers, exporters & distributors?

    Difluprednate manufacturers, exporters & distributors 1

    64

    PharmaCompass offers a list of Difluprednate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Difluprednate manufacturer or Difluprednate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Difluprednate manufacturer or Difluprednate supplier.

    PharmaCompass also assists you with knowing the Difluprednate API Price utilized in the formulation of products. Difluprednate API Price is not always fixed or binding as the Difluprednate Price is obtained through a variety of data sources. The Difluprednate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Difluprednate

    Synonyms

    23674-86-4, Durezol, Dfba, Myser, Epitopic, [(6s,8s,9r,10s,11s,13s,14s,17r)-17-(2-acetyloxyacetyl)-6,9-difluoro-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] butanoate

    Cas Number

    23674-86-4

    Unique Ingredient Identifier (UNII)

    S8A06QG2QE

    About Difluprednate

    Difluprednate is a topical corticosteroid and prednisolone acetate derivative, with anti-inflammatory activity. Upon instillation into the eye, difluprednate binds to and activates the glucocorticoid receptor (GR). The receptor-ligand complex binds to promoter regions of certain genes and initiates RNA transcription. This results in an induction of synthesis of phospholipase A2 inhibitory proteins, thereby inhibiting the synthesis of arachidonic acid and preventing the synthesis of certain inflammatory mediators, such as prostaglandins and leukotrienes. This reduces ocular inflammation and pain.

    Difluprednate Manufacturers

    A Difluprednate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difluprednate, including repackagers and relabelers. The FDA regulates Difluprednate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difluprednate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Difluprednate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Difluprednate Suppliers

    A Difluprednate supplier is an individual or a company that provides Difluprednate active pharmaceutical ingredient (API) or Difluprednate finished formulations upon request. The Difluprednate suppliers may include Difluprednate API manufacturers, exporters, distributors and traders.

    click here to find a list of Difluprednate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Difluprednate USDMF

    A Difluprednate DMF (Drug Master File) is a document detailing the whole manufacturing process of Difluprednate active pharmaceutical ingredient (API) in detail. Different forms of Difluprednate DMFs exist exist since differing nations have different regulations, such as Difluprednate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Difluprednate DMF submitted to regulatory agencies in the US is known as a USDMF. Difluprednate USDMF includes data on Difluprednate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Difluprednate USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Difluprednate suppliers with USDMF on PharmaCompass.

    Difluprednate Manufacturers | Traders | Suppliers

    Difluprednate Manufacturers, Traders, Suppliers 1
    51

    We have 4 companies offering Difluprednate

    Get in contact with the supplier of your choice:

    1. Axplora
    2. ChemWerth Inc
    3. Teva API
    4. Steroid SpA
    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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