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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]

    API Reference Price

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    27-Jan-2021
    24-Feb-2025
    KGS
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    DOSAGE - CAPSULE;ORAL - 10MG

    USFDA APPLICATION NUMBER - 21977

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    DOSAGE - CAPSULE;ORAL - 70MG

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    ABOUT THIS PAGE

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

    Lisdexamfetamine Dimesylate manufacturers, exporters & distributors 1

    17

    PharmaCompass offers a list of Lisdexamfetamine Dimesylate 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 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.

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

    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.

    Venvanse Manufacturers

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

    Venvanse Suppliers

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

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

    Venvanse USDMF

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

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

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

    Venvanse WC

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

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

    Venvanse 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 Venvanse as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Venvanse GMP

    Venvanse 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 Venvanse 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 Venvanse GMP manufacturer or Venvanse GMP API supplier for your needs.

    Venvanse CoA

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

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

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