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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

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    Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis

    Details:

    Copaxone Depot, a long-acting glatiramer acetate designed to be administered as an intramuscular injection, is being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS).


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Neurology Brand Name: WhisperJECT

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Mapi Pharma

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 08, 2023

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    01

    Viatris

    U.S.A
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    Viatris

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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Mapi Pharma

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for th...

    Details : Copaxone Depot, a long-acting glatiramer acetate designed to be administered as an intramuscular injection, is being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS).

    Product Name : WhisperJECT

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 08, 2023

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    Kinimmune Publishes Results from A Phase I “Window of Opportunity” Trial in Patients with Solid Tumors

    Details:

    Copaxone (glatiramer acetate) its ability to induce the peripheral Th2 cells and their subsequent crossing of the blood barrier allows for the reduction of further inflammation within the CNS.


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Oncology Brand Name: Copaxone

    Study Phase: Phase IProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 03, 2023

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    02

    Kinimmune

    U.S.A
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    Kinimmune

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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Kinimmune Publishes Results from A Phase I “Window of Opportunity” Trial in Patients with Soli...

    Details : Copaxone (glatiramer acetate) its ability to induce the peripheral Th2 cells and their subsequent crossing of the blood barrier allows for the reduction of further inflammation within the CNS.

    Product Name : Copaxone

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 03, 2023

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    COPAXONE® Label Now Indicates Its Use in Breastfeeding Mothers with Relapsing Multiple Sclerosis

    Details:

    The label update of COPAXONE® (Glatiramer Acetate) follows the review of clinical and non-clinical evidence, including latest data from the COBRA study that investigated safety outcomes in infants breastfed by mothers with MS undergoing GA treatment during the first 18 months.


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Neurology Brand Name: Copaxone

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 02, 2022

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    03

    Teva Pharmaceutical Industries

    Israel
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    Teva Pharmaceutical Industries

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    Not Confirmed
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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    COPAXONE® Label Now Indicates Its Use in Breastfeeding Mothers with Relapsing Multiple Sclerosis

    Details : The label update of COPAXONE® (Glatiramer Acetate) follows the review of clinical and non-clinical evidence, including latest data from the COBRA study that investigated safety outcomes in infants breastfed by mothers with MS undergoing GA treatment dur...

    Product Name : Copaxone

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 02, 2022

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    Mapi Pharma Announces Positive Top-Line Results from GA Depot Phase III Trial for Relapsing Forms of Multiple Sclerosis (RMS)

    Details:

    The study evaluating a long-acting glatiramer acetate (copaxone) injection, GA Depot 40 mg once every four weeks, met the primary endpoint, significantly reducing the annualized relapse rate (ARR) by 30.1 percent compared to placebo.


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Neurology Brand Name: GA Depot

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Viatris

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 21, 2022

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    04

    Mapi Pharma

    Israel
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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Viatris

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mapi Pharma Announces Positive Top-Line Results from GA Depot Phase III Trial for Relapsing Forms ...

    Details : The study evaluating a long-acting glatiramer acetate (copaxone) injection, GA Depot 40 mg once every four weeks, met the primary endpoint, significantly reducing the annualized relapse rate (ARR) by 30.1 percent compared to placebo.

    Product Name : GA Depot

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    September 21, 2022

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    Mapi Pharma to Present Posters on GA Depot for Treating Relapsing Forms of Multiple Sclerosis (MS) and Primary Progressive Forms of Multiple Sclerosis a...

    Details:

    At AAN, company will be presenting 5 year data from Phase IIa study in RRMS. Also, the results seeN in the ongoing Phase II study for GA Depot in primary progressive MS (PPMS) patients, to be presented at the meeting as plan to initiate a Phase-3 for PPMS at the end of 2022.


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Neurology Brand Name: GA Depot

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 31, 2022

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    05

    Mapi Pharma

    Israel
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    Not Confirmed

    Mapi Pharma

    Israel
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    Not Confirmed
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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mapi Pharma to Present Posters on GA Depot for Treating Relapsing Forms of Multiple Sclerosis (MS)...

    Details : At AAN, company will be presenting 5 year data from Phase IIa study in RRMS. Also, the results seeN in the ongoing Phase II study for GA Depot in primary progressive MS (PPMS) patients, to be presented at the meeting as plan to initiate a Phase-3 for PPM...

    Product Name : GA Depot

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 31, 2022

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    Mapi Pharma Receives U.S. Patent Covering Methods of Suppressing or Alleviating Primary or Secondary Progressive Multiple Sclerosis with a Sustained Rel...

    Details:

    GA Depot is a long-acting injection version of the approved Copaxone® (Glatiramer Acetate) designed to be administered as an intramuscular injection once every four weeks, is being evaluated for treatment of relapsing forms of multiple sclerosis.


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Neurology Brand Name: GA Depot

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 30, 2022

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    06

    Mapi Pharma

    Israel
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    Mapi Pharma

    Israel
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    Not Confirmed
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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mapi Pharma Receives U.S. Patent Covering Methods of Suppressing or Alleviating Primary or Seconda...

    Details : GA Depot is a long-acting injection version of the approved Copaxone® (Glatiramer Acetate) designed to be administered as an intramuscular injection once every four weeks, is being evaluated for treatment of relapsing forms of multiple sclerosis.

    Product Name : GA Depot

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 30, 2022

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    New Safety Data on Treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis

    Details:

    Patients were eligible for the study if they were diagnosed with relapsing MS (RMS), gave a live birth, were breastfeeding under GA treatment (COPAXONE® 20 or 40 mg/mL) or breastfeeding under no DMT treatment.


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Neurology Brand Name: Copaxone

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 13, 2021

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    07

    Teva Pharmaceutical Industries

    Israel
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    Not Confirmed

    Teva Pharmaceutical Industries

    Israel
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    German Wound Congress
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    New Safety Data on Treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Liv...

    Details : Patients were eligible for the study if they were diagnosed with relapsing MS (RMS), gave a live birth, were breastfeeding under GA treatment (COPAXONE® 20 or 40 mg/mL) or breastfeeding under no DMT treatment.

    Product Name : Copaxone

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 13, 2021

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    New Safety Data on Treatment of Breastfeeding Mothers with COPAXONE® (glatiramer acetate) Who Are Living with Relapsing Multiple Sclerosis

    Details:

    A non-interventional analysis of the study found no evidence of safety concerns in infants born to mothers with multiple sclerosis (MS) who were breastfeeding and receiving glatiramer acetate (GA) treatment.


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Neurology Brand Name: Copaxone

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 22, 2021

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    08

    Teva Pharmaceutical Industries

    Israel
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    Not Confirmed

    Teva Pharmaceutical Industries

    Israel
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    German Wound Congress
    Not Confirmed
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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    New Safety Data on Treatment of Breastfeeding Mothers with COPAXONE® (glatiramer acetate) Who Are...

    Details : A non-interventional analysis of the study found no evidence of safety concerns in infants born to mothers with multiple sclerosis (MS) who were breastfeeding and receiving glatiramer acetate (GA) treatment.

    Product Name : Copaxone

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    June 22, 2021

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    Mapi Pharma Engages PRA Health Sciences as CRO for Phase III Multiple Sclerosis Trial

    Details:

    GA Depot is a long-acting version of Teva Pharmaceutical’s Copaxone (glatiramer acetate). Mapi Pharma is working with the CRO PRA Health Sciences for its Phase III trial investigating glatiramer acetate depot (GA Depot) for relapsing forms of multiple sclerosis (RMS).


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Neurology Brand Name: GA Depot

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: PRA Health Sciences

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 20, 2021

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    09

    Mapi Pharma

    Israel
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    Mapi Pharma

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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : PRA Health Sciences

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mapi Pharma Engages PRA Health Sciences as CRO for Phase III Multiple Sclerosis Trial

    Details : GA Depot is a long-acting version of Teva Pharmaceutical’s Copaxone (glatiramer acetate). Mapi Pharma is working with the CRO PRA Health Sciences for its Phase III trial investigating glatiramer acetate depot (GA Depot) for relapsing forms of multiple ...

    Product Name : GA Depot

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 20, 2021

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    Mapi Pharma Provides Enrollment Update in Phase III GA Depot Clinical Trial

    Details:

    GA Depot is a long acting injection version of the approved Glatiramer Acetate products (Copaxone® and its generic versions) for treating multiple sclerosis (RMS), designed to be administered as an intramuscular injection once every four weeks.


    Lead Product(s): Glatiramer Acetate

    Therapeutic Area: Neurology Brand Name: GA Depot

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Viatris

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 21, 2020

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    10

    Mapi Pharma

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    Lead Product(s) : Glatiramer Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Viatris

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mapi Pharma Provides Enrollment Update in Phase III GA Depot Clinical Trial

    Details : GA Depot is a long acting injection version of the approved Glatiramer Acetate products (Copaxone® and its generic versions) for treating multiple sclerosis (RMS), designed to be administered as an intramuscular injection once every four weeks.

    Product Name : GA Depot

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 21, 2020

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    DRUG PRODUCT COMPOSITIONS

    Do you need Business Intel? Ask us

    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

    Looking for 147245-92-9 / Glatiramer Acetate API manufacturers, exporters & distributors?

    Glatiramer Acetate manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Glatiramer Acetate

    Synonyms

    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

    Cas Number

    147245-92-9

    About 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.

    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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