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

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    Glatiramer

    APIs // Active Pharmaceutical Ingredients

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    AMBIOPHARM INC

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    GLATIRAMER ACETATE

    PDF Supplier PDF
    URL Supplier Web Content
    26489
    Active
    2012-09-27
    Complete
    2015-01-05
    2014-06-09
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    Looking for 28704-27-0 / Glatiramer API manufacturers, exporters & distributors?

    Glatiramer manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Glatiramer 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 Glatiramer manufacturer or Glatiramer supplier for your needs.

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

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

    API | Excipient name

    Glatiramer

    Synonyms

    28704-27-0, Cop-1, (2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid, Dtxsid50182865

    Cas Number

    28704-27-0

    About Glatiramer

    Glatiramer acetate consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000-9,000 daltons. It is an immunomodulator, licensed in much of the world for reduced frequency of relapses in relapsing-remitting multiple sclerosis.

    Glatiramer Manufacturers

    A Glatiramer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glatiramer, including repackagers and relabelers. The FDA regulates Glatiramer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glatiramer 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 Glatiramer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Glatiramer Suppliers

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

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

    Glatiramer USDMF

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

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

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

    Glatiramer Manufacturers | Traders | Suppliers

    Glatiramer Manufacturers, Traders, Suppliers 1
    79

    We have 1 companies offering Glatiramer

    Get in contact with the supplier of your choice:

    1. AmbioPharm
    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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