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    Chemistry

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    Also known as: 147245-92-9, Acetic acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid, Glatirameracetat, Dtxsid30163637, Am84438, Ac-28732
    Molecular Formula
    C25H45N5O13
    Molecular Weight
    623.7  g/mol
    InChI Key
    FHEAIOHRHQGZPC-KIWGSFCNSA-N
    Glatiramer Acetate
    A random polymer of L-ALANINE, L-GLUTAMIC ACID, L-LYSINE, and L-TYROSINE that structurally resembles MYELIN BASIC PROTEIN. It is used in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS.
    1 2D Structure

    Glatiramer Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    acetic acid;(2S)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2S)-2-aminopentanedioic acid;(2S)-2-aminopropanoic acid;(2S)-2,6-diaminohexanoic acid
    2.1.2 InChI
    InChI=1S/C9H11NO3.C6H14N2O2.C5H9NO4.C3H7NO2.C2H4O2/c10-8(9(12)13)5-6-1-3-7(11)4-2-6;7-4-2-1-3-5(8)6(9)10;6-3(5(9)10)1-2-4(7)8;1-2(4)3(5)6;1-2(3)4/h1-4,8,11H,5,10H2,(H,12,13);5H,1-4,7-8H2,(H,9,10);3H,1-2,6H2,(H,7,8)(H,9,10);2H,4H2,1H3,(H,5,6);1H3,(H,3,4)/t8-;5-;3-;2-;/m0000./s1
    2.1.3 InChI Key
    FHEAIOHRHQGZPC-KIWGSFCNSA-N
    2.1.4 Canonical SMILES
    CC(C(=O)O)N.CC(=O)O.C1=CC(=CC=C1CC(C(=O)O)N)O.C(CCN)CC(C(=O)O)N.C(CC(=O)O)C(C(=O)O)N
    2.1.5 Isomeric SMILES
    C[C@@H](C(=O)O)N.CC(=O)O.C1=CC(=CC=C1C[C@@H](C(=O)O)N)O.C(CCN)C[C@@H](C(=O)O)N.C(CC(=O)O)[C@@H](C(=O)O)N
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. 5010, Tv

    2. Acetate, Glatiramer

    3. Copaxone

    4. Glatiramer

    5. Tv 5010

    6. Tv-5010

    7. Tv5010

    2.2.2 Depositor-Supplied Synonyms

    1. 147245-92-9

    2. Acetic Acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic Acid;(2s)-2-aminopentanedioic Acid;(2s)-2-aminopropanoic Acid;(2s)-2,6-diaminohexanoic Acid

    3. Glatirameracetat

    4. Dtxsid30163637

    5. Am84438

    6. Ac-28732

    7. L-alanine Compound With L-glutamic Acid And L-lysine And L-tyrosine And Acetic Acid (1:1:1:1:1)

    8. Q418274

    2.3 Create Date
    2005-08-09
    3 Chemical and Physical Properties
    Molecular Weight 623.7 g/mol
    Molecular Formula C25H45N5O13
    Hydrogen Bond Donor Count12
    Hydrogen Bond Acceptor Count18
    Rotatable Bond Count13
    Exact Mass623.30138651 g/mol
    Monoisotopic Mass623.30138651 g/mol
    Topological Polar Surface Area374 Ų
    Heavy Atom Count43
    Formal Charge0
    Complexity519
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count5
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameCopaxone
    PubMed HealthGlatiramer (Injection)
    Drug ClassesCentral Nervous System Agent, Immune Suppressant, Musculoskeletal Agent
    Drug LabelGlatiramer acetate, the active ingredient of COPAXONE, 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....
    Active IngredientGlatiramer acetate
    Dosage FormInjectable
    RouteSubcutaneous
    Strength20mg/ml; 40mg/ml
    Market StatusPrescription
    CompanyTeva Pharms Usa

    2 of 2  
    Drug NameCopaxone
    PubMed HealthGlatiramer (Injection)
    Drug ClassesCentral Nervous System Agent, Immune Suppressant, Musculoskeletal Agent
    Drug LabelGlatiramer acetate, the active ingredient of COPAXONE, 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....
    Active IngredientGlatiramer acetate
    Dosage FormInjectable
    RouteSubcutaneous
    Strength20mg/ml; 40mg/ml
    Market StatusPrescription
    CompanyTeva Pharms Usa

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antirheumatic Agents

    Drugs that are used to treat RHEUMATOID ARTHRITIS. (See all compounds classified as Antirheumatic Agents.)

    Immunosuppressive Agents

    Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

    Adjuvants, Immunologic

    Substances that augment, stimulate, activate, potentiate, or modulate the immune response at either the cellular or humoral level. The classical agents (Freund's adjuvant, BCG, Corynebacterium parvum, et al.) contain bacterial antigens. Some are endogenous (e.g., histamine, interferon, transfer factor, tuftsin, interleukin-1). Their mode of action is either non-specific, resulting in increased immune responsiveness to a wide variety of antigens, or antigen-specific, i.e., affecting a restricted type of immune response to a narrow group of antigens. The therapeutic efficacy of many biological response modifiers is related to their antigen-specific immunoadjuvanticity. (See all compounds classified as Adjuvants, Immunologic.)

    5.2 ATC Code

    L03AX13

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    L - Antineoplastic and immunomodulating agents

    L03 - Immunostimulants

    L03A - Immunostimulants

    L03AX - Other immunostimulants

    L03AX13 - Glatiramer acetate

    API Reference Price

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    26-Apr-2021
    31-Dec-2024
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    DOSAGE - FOR SOLUTION;SUBCUTANEOUS - 20MG/VIA...DOSAGE - FOR SOLUTION;SUBCUTANEOUS - 20MG/VIAL

    USFDA APPLICATION NUMBER - 20622

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    DOSAGE - INJECTABLE;SUBCUTANEOUS - 40MG/ML

    USFDA APPLICATION NUMBER - 20622

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    ABOUT THIS PAGE

    Glatiramer Acetate Manufacturers

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

    Glatiramer Acetate Suppliers

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

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

    Glatiramer Acetate USDMF

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

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

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

    Glatiramer Acetate WC

    A Glatiramer Acetate written confirmation (Glatiramer Acetate WC) is an official document issued by a regulatory agency to a Glatiramer Acetate manufacturer, verifying that the manufacturing facility of a Glatiramer Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Glatiramer Acetate APIs or Glatiramer Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Glatiramer Acetate WC (written confirmation) as part of the regulatory process.

    click here to find a list of Glatiramer Acetate suppliers with Written Confirmation (WC) on PharmaCompass.

    Glatiramer Acetate NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Glatiramer Acetate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Glatiramer Acetate API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Glatiramer Acetate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Glatiramer Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glatiramer Acetate NDC to their finished compounded human drug products, they may choose to do so.

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

    Glatiramer Acetate GMP

    Glatiramer Acetate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

    Glatiramer Acetate CoA

    A Glatiramer Acetate CoA (Certificate of Analysis) is a formal document that attests to Glatiramer Acetate's compliance with Glatiramer Acetate specifications and serves as a tool for batch-level quality control.

    Glatiramer Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Glatiramer Acetate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Glatiramer Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Glatiramer Acetate EP), Glatiramer Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glatiramer Acetate USP).

    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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