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    Synopsis

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    Chemistry

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    Also known as: Vyvanse, 608137-33-3, Nrp-104, Lisdexamfetamine mesilate, Spd489, Tyvense
    Molecular Formula
    C17H33N3O7S2
    Molecular Weight
    455.6  g/mol
    InChI Key
    CETWSOHVEGTIBR-FORAGAHYSA-N
    FDA UNII
    SJT761GEGS
    Lisdexamfetamine Dimesylate
    A dextroamphetamine drug precursor that also functions as a CENTRAL NERVOUS SYSTEM STIMULANT and DOPAMINE UPTAKE INHIBITOR and is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
    1 2D Structure

    Lisdexamfetamine Dimesylate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2,6-diamino-N-[(2S)-1-phenylpropan-2-yl]hexanamide;methanesulfonic acid
    2.1.2 InChI
    InChI=1S/C15H25N3O.2CH4O3S/c1-12(11-13-7-3-2-4-8-13)18-15(19)14(17)9-5-6-10-16;2*1-5(2,3)4/h2-4,7-8,12,14H,5-6,9-11,16-17H2,1H3,(H,18,19);2*1H3,(H,2,3,4)/t12-,14-;;/m0../s1
    2.1.3 InChI Key
    CETWSOHVEGTIBR-FORAGAHYSA-N
    2.1.4 Canonical SMILES
    CC(CC1=CC=CC=C1)NC(=O)C(CCCCN)N.CS(=O)(=O)O.CS(=O)(=O)O
    2.1.5 Isomeric SMILES
    C[C@@H](CC1=CC=CC=C1)NC(=O)[C@H](CCCCN)N.CS(=O)(=O)O.CS(=O)(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    SJT761GEGS
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Dimesylate, Lis-dexamfetamine

    2. Dimesylate, Lisdexamfetamine

    3. Elvanse

    4. Lis Dexamfetamine Dimesylate

    5. Lis-dexamfetamine Dimesylate

    6. Lisdexamfetamine

    7. Nrp 104

    8. Nrp-104

    9. Nrp104

    10. Vyvanse

    2.3.2 Depositor-Supplied Synonyms

    1. Vyvanse

    2. 608137-33-3

    3. Nrp-104

    4. Lisdexamfetamine Mesilate

    5. Spd489

    6. Tyvense

    7. Nrp104

    8. Spd-489

    9. Lisdexamfetamine Dimesylate [usan]

    10. Lisdexamfetamine Dimesilate

    11. Sjt761gegs

    12. Lisdexamphetamine Dimesilate

    13. L-lysine-d-amphetamine Dimesylate

    14. Lisdexamfetamine Dimethanesulfonate

    15. (2s)-2,6-diamino-n-[(1s)-1-methyl-2-phenylethyl]hexanamide Dimethanesulfonate

    16. Lis-dexamfetamine Dimesylate

    17. Lisdexamfetamine Mesilate (jan)

    18. Lisdexamfetamine Dimesylate (usan)

    19. Lisdexamfetamine Mesylate

    20. Nrp 104

    21. Lisdexamfetamine Mesilate [jan]

    22. (2s)-2,6-diamino-n-[(2s)-1-phenylpropan-2-yl]hexanamide;methanesulfonic Acid

    23. Unii-sjt761gegs

    24. Venvanse

    25. (2s)-2,6-diamino-n-((1s)-1-methyl-2-phenylethyl)hexanamide Dimethanesulfonate

    26. Lys-amp

    27. Spd 489

    28. Lys-d-amp

    29. Elvanse (tn)

    30. Vyvanse (tn)

    31. Schembl678421

    32. Chembl1201178

    33. Dtxsid60209653

    34. Lisdexamfetamine Dimesylate Solution

    35. Bcp24044

    36. Akos030254940

    37. Lisdexamfetamine Mesilate [mart.]

    38. Ldx

    39. Lisdexamfetamine Mesilate [who-dd]

    40. Lisdexamfetamine Dimesylate [vandf]

    41. D04747

    42. Lisdexamfetamine Dimethanesulfonate [mi]

    43. Lisdexamfetamine Dimesylate [orange Book]

    44. 137l333

    45. Q27289243

    46. (2s)-2,6-diamino-n-((1s)-1-methyl-2-phenylethyl)hexanamide Dimethanesulphonate

    47. Hexanamide, 2,6-diamino-n-((1s)-1-methyl-2-phenylethyl), (2s), Dimethanesulfonate

    48. Hexanamide, 2,6-diamino-n-((1s)-1-methyl-2-phenylethyl), (2s), Dimethanesulphonate

    49. Ldx;lisdexamfetamine Mesilate;lisdexamfetamine Mesylate;nrp 104;nrp-104;spd 489

    50. Lisdexamfetamine Dimesylate Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 455.6 g/mol
    Molecular Formula C17H33N3O7S2
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count8
    Exact Mass455.17599275 g/mol
    Monoisotopic Mass455.17599275 g/mol
    Topological Polar Surface Area207 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity344
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameLisdexamfetamine dimesylate
    Drug LabelVyvanse (lisdexamfetamine dimesylate), a CNS stimulant,isa capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate....
    Active IngredientLisdexamfetamine dimesylate
    Dosage FormCapsule
    RouteOral
    Strength30mg; 50mg; 60mg; 40mg; 70mg; 20mg
    Market StatusTentative Approval
    CompanyMylan Pharms; Amneal Pharms; Roxane

    2 of 4  
    Drug NameVyvanse
    PubMed HealthAmphetamine (By mouth)
    Drug ClassesAmphetamine
    Drug LabelVyvanse (lisdexamfetamine dimesylate), a CNS stimulant,isa capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate....
    Active IngredientLisdexamfetamine dimesylate
    Dosage FormCapsule
    RouteOral
    Strength30mg; 50mg; 60mg; 40mg; 20mg; 70mg
    Market StatusPrescription
    CompanyShire Development

    3 of 4  
    Drug NameLisdexamfetamine dimesylate
    Drug LabelVyvanse (lisdexamfetamine dimesylate), a CNS stimulant,isa capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate....
    Active IngredientLisdexamfetamine dimesylate
    Dosage FormCapsule
    RouteOral
    Strength30mg; 50mg; 60mg; 40mg; 70mg; 20mg
    Market StatusTentative Approval
    CompanyMylan Pharms; Amneal Pharms; Roxane

    4 of 4  
    Drug NameVyvanse
    PubMed HealthAmphetamine (By mouth)
    Drug ClassesAmphetamine
    Drug LabelVyvanse (lisdexamfetamine dimesylate), a CNS stimulant,isa capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate....
    Active IngredientLisdexamfetamine dimesylate
    Dosage FormCapsule
    RouteOral
    Strength30mg; 50mg; 60mg; 40mg; 20mg; 70mg
    Market StatusPrescription
    CompanyShire Development

    4.2 Drug Indication

    Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Central Nervous System Stimulants

    A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)

    Dopamine Uptake Inhibitors

    Drugs that block the transport of DOPAMINE into axon terminals or into storage vesicles within terminals. Most of the ADRENERGIC UPTAKE INHIBITORS also inhibit dopamine uptake. (See all compounds classified as Dopamine Uptake Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Central Nervous System Stimulation [PE]; Central Nervous System Stimulant [EPC]

    Drugs in Development

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    • Development Update
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    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules Strengthens ADHD Portfolio with FDA Approval for Lisdexamfetamine Dimesylate

    Details:

    FDA approved Lisdexamfetamine Dimesylate Capsules, a bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder.


    Lead Product(s): Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Vyvanse-Generic

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 30, 2025

    Granules India

    01

    Granules India Limited

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    Booth #E1K58
    • fda
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    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Lead Product(s) : Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Granules Strengthens ADHD Portfolio with FDA Approval for Lisdexamfetamine Dimesylate

    Details : FDA approved Lisdexamfetamine Dimesylate Capsules, a bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder.

    Product Name : Vyvanse-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    January 30, 2025

    Granules India

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    • Development Update
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    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited Announces FDA Approval for ADHD Treatment

    Details:

    FDA approved Lisdexamfetamine Dimesylate Tablets, a bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder.


    Lead Product(s): Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Vyvanse-Generic

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 17, 2024

    Granules India

    02

    Granules India Limited

    India
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    CPhI China
    Booth #E1K58
    • fda
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    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Lead Product(s) : Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Granules India Limited Announces FDA Approval for ADHD Treatment

    Details : FDA approved Lisdexamfetamine Dimesylate Tablets, a bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder.

    Product Name : Vyvanse-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    December 17, 2024

    Granules India

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    A Trial to Assess How Centanafadine Interacts With Stimulants in the Body

    Details:

    Centanafadine is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.


    Lead Product(s): Centanafadine,Methylphenidate,Lisdexamfetamine Dimesylate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 02, 2026

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    Otsuka Pharmaceutical

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    Otsuka Pharmaceutical

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    Lead Product(s) : Centanafadine,Methylphenidate,Lisdexamfetamine Dimesylate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Trial to Assess How Centanafadine Interacts With Stimulants in the Body

    Details : Centanafadine is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 02, 2026

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    Lisdexamfetamine 70 mg vs Elvanse® 70 mg Bioavailability Under Fasting In Healthy Adults

    Details:

    Lisdexamfetamine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.


    Lead Product(s): Lisdexamfetamine Dimesylate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 01, 2025

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    Humanis

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    Humanis

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    Lead Product(s) : Lisdexamfetamine Dimesylate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lisdexamfetamine 70 mg vs Elvanse® 70 mg Bioavailability Under Fasting In Healthy Adults

    Details : Lisdexamfetamine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 01, 2025

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    Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate

    Details:

    Lisdexamfetamine dimesylate capsules, for oral use is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder and Moderate to Severe Binge Eating Disorder (BED) in adults.


    Lead Product(s): Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Vyvanse-Generic

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 06, 2023

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    Amneal Pharmaceuticals

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    Lead Product(s) : Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate

    Details : Lisdexamfetamine dimesylate capsules, for oral use is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder and Moderate to Severe Binge Eating Disorder (BED) in adults.

    Product Name : Vyvanse-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    September 06, 2023

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    Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Product Used to Treat Attention-Deficit/Hyperactivity Diso...

    Details:

    Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the FDA's drug shortage list.


    Lead Product(s): Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Vyvanse-Generic

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 31, 2023

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    Mallinckrodt Pharmaceuticals

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    Lead Product(s) : Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Prod...

    Details : Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the FDA's drug shortage list.

    Product Name : Vyvanse-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    August 31, 2023

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    Lisdexamfetamine for Adults With Bulimia Nervosa

    Details:

    Lisdexamfetamine Dimesylate is a Controlled Substance drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Bulimia Nervosa.


    Lead Product(s): Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Controlled Substance

    Sponsor: Nova Scotia Health Authority

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 12, 2018

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    Nova Scotia Health Authority

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    Lead Product(s) : Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Nova Scotia Health Authority

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lisdexamfetamine for Adults With Bulimia Nervosa

    Details : Lisdexamfetamine Dimesylate is a Controlled Substance drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Bulimia Nervosa.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    January 12, 2018

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    Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism

    Details:

    Lisdexamfetamine Dimesylate is a Controlled Substance drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.


    Lead Product(s): Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Controlled Substance

    Sponsor: SHIRE PLC

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 09, 2017

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    JPM van Stralen Medicine Professional

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    JPM van Stralen Medicine Professional

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    Lead Product(s) : Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : SHIRE PLC

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism

    Details : Lisdexamfetamine Dimesylate is a Controlled Substance drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    November 09, 2017

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    Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents

    Details:

    Lisdexamfetamine Dimesylate is a Controlled Substance drug candidate, which is currently being evaluated in clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.


    Lead Product(s): Lisdexamfetamine Dimesylate,Guanfacine

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Controlled Substance

    Sponsor: SHIRE PLC

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 07, 2017

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    Lead Product(s) : Lisdexamfetamine Dimesylate,Guanfacine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : SHIRE PLC

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents

    Details : Lisdexamfetamine Dimesylate is a Controlled Substance drug candidate, which is currently being evaluated in clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    November 07, 2017

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    Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

    Details:

    Vyvanse (Lisdexamfetamine Dimesylate) is a Controlled Substance drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.


    Lead Product(s): Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Vyvanse

    Study Phase: Phase IIIProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 24, 2017

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    SHIRE PLC

    United Kingdom
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    Lead Product(s) : Lisdexamfetamine Dimesylate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivit...

    Details : Vyvanse (Lisdexamfetamine Dimesylate) is a Controlled Substance drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.

    Product Name : Vyvanse

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    August 24, 2017

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    INTERMEDIATE SUPPLIERS

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    01

    Cohance Lifesciences

    India
    CPhI Milan
    Booth #6C39
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Tert-butyl N-[(2S)-6-[(2-methylpropan-2-yl)oxycarb...

    CAS Number : 819871-13-1

    End Use API : Lisdexamfetamine Dimesylate

    About The Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercializati...

    Cohance

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    Suanfarma

    Spain
    CPhI Milan
    Booth #4A39
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    Virtual BoothSuanfarma, at the Core of a Better Life.

    Boc-Lys(Boc)-Onp

    CAS Number : 2592-19-0

    End Use API : Lisdexamfetamine Dimesylate

    About The Company : Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an i...

    Suanfarma

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    Anvitha Lifecare

    India
    PEGS Boston Summit
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    PEGS Boston Summit
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    (4S,5R) -(-)-4-Methyl-5-phenyl-2-oxazolidinone

    CAS Number : 16251-45-9

    End Use API : Lisdexamfetamine Dimesylate

    About The Company : Anvitha Life Care Private Limited, founded in 2016 by Dr. T. Prakasam and a team of experienced scientists and technocrats with over 80 years of combined expert...

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    DOSAGE - CAPSULE;ORAL - 10MG

    USFDA APPLICATION NUMBER - 21977

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    DOSAGE - CAPSULE;ORAL - 70MG

    USFDA APPLICATION NUMBER - 21977

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    turkeypng-1602828403png-1622460951png-1622462103.png
    Lisdexamfetamine Dimesylate API needed in Turkey [ENA25129]
    A company that focuses on the manufacturing of various finished dosage formulations is looking for suppliers of Lisdexamfetamine Dimesylate for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
    23 Jan 2026

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    23 Jan 2026

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    Reply Comment (8)

    23 Jan 2026

    Bangladesh.png
    Lisdexamfetamine Dimesylate (220 kg/ annum) API needed in Bangladesh [ENA24719]
    A company that focuses on the manufacturing of various finished formulations is looking for suppliers of Lisdexamfetamine Dimesylate (220 kg/ annum) API for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
    03 Dec 2025

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    03 Dec 2025

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    Reply Comment (6)

    03 Dec 2025

    China.png
    Lisdexamfetamine (1 kg) API needed in China [ENA23777]
    A company that focuses on development and manufacturing of various pharmaceutical products is looking for suppliers of Lisdexamfetamine (1 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    15 Aug 2025

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    15 Aug 2025

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    15 Aug 2025

    india-flag.png
    USP Grade Lisdexamfetamine Dimesylate (5 kg) API needed in India [ENA23709]
    A company that focuses on research, development & manufacturing of pellets is looking for suppliers of USP Grade Lisdexamfetamine Dimesylate (5 kg) API for development purposes. The suppliers must support this enquiry with DMF & CoA.
    06 Aug 2025

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    06 Aug 2025

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    06 Aug 2025

    United_States_of_America.png
    Lisdexamfetamine Dimesylate API needed in the U.S.A [ENA22862]
    A company that focuses on research, development and manufacturing of various finished formulations in gastrointestinal, oncology, neuroscience, plasma-derived therapies & rare diseases is looking for suppliers of Lisdexamfetamine Dimesylate API for commercial purposes. The suppliers must support this enquiry with CoA.
    03 May 2025

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    03 May 2025

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    03 May 2025

    United_States_of_America.png
    Lisdexamfetamine Mesylate API needed in the U.S.A [ENA22537]
    A pharmaceutical contract development and manufacturing organization that formulates solids, semi-solids, inhalation, liquid, injectable & ophthalmic medications is looking for suppliers of Lisdexamfetamine Mesylate API for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
    03 Apr 2025

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    03 Apr 2025

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    03 Apr 2025

    United_States_of_America.png
    Lisdexamfetamine Dimesylate API needed in U.S.A [ENA22033]
    A company that focuses on design, development and manufacturing of OSDs, drops & parenterals is looking for suppliers of Lisdexamfetamine Dimesylate (300 kg) API for both development and commercial purposes. The suppliers must support this enquiry with USDMF or CEP & CoA.
    12 Feb 2025

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    12 Feb 2025

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    12 Feb 2025

    india-flag.png
    Lisdexamfetamine API needed in India [ENA21866]
    A company that focuses on the development and manufacturing of various liquids, ointments and personal care products is looking for suppliers of Lisdexamfetamine API for development purposes. The suppliers must support this enquiry with GMP & CoA.
    25 Jan 2025

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    25 Jan 2025

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    25 Jan 2025

    india-flag.png
    Lisdexamfetamine Dimesylate API needed in India [ENA21654]
    A globally renowned company that focuses on research, development, manufacturing and marketing of pharmaceuticals & biopharmaceutical formulations is looking for suppliers of Lisdexamfetamine Dimesylate API for capsule formulation. The required quantity is 100 kg for development & 230 kg for commercial purposes. The suppliers must support this enquiry with EDMF, GMP and CoA.
    06 Jan 2025

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    06 Jan 2025

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    Reply Comment (1)

    06 Jan 2025

    Spain_new.png
    Lisdexamfetamine Dimesylate API needed in Spain [ENA20929]
    A company that focuses on development and manufacturing of various finished formualtions is looking for suppliers of Lisdexamfetamine Dimesylate API for both development and commercial purposes. The initial required quantity is 2 kg and later 120 kg for validation batches. The suppliers must support this enquiry with CoA.
    23 Oct 2024

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    23 Oct 2024

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    23 Oct 2024

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    Patents & EXCLUSIVITIES

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    ABOUT THIS PAGE

    Looking for 608137-33-3 / Lisdexamfetamine Dimesylate API manufacturers, exporters & distributors?

    Lisdexamfetamine Dimesylate manufacturers, exporters & distributors 1

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

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

    API | Excipient name

    Lisdexamfetamine Dimesylate

    Synonyms

    Vyvanse, 608137-33-3, Nrp-104, Lisdexamfetamine mesilate, Spd489, Tyvense

    Cas Number

    608137-33-3

    Unique Ingredient Identifier (UNII)

    SJT761GEGS

    About Lisdexamfetamine Dimesylate

    A dextroamphetamine drug precursor that also functions as a CENTRAL NERVOUS SYSTEM STIMULANT and DOPAMINE UPTAKE INHIBITOR and is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

    Vyvanse Manufacturers

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

    Vyvanse Suppliers

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

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

    Vyvanse USDMF

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

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

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

    Vyvanse WC

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

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

    Vyvanse 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 Vyvanse as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Vyvanse 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 Vyvanse 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 Vyvanse and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vyvanse NDC to their finished compounded human drug products, they may choose to do so.

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

    Vyvanse GMP

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

    Vyvanse CoA

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

    Vyvanse CoA mostly includes findings from lab analyses of a specific batch. For each Vyvanse 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.

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