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    Chemistry

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    Also known as: Dl-amphetamine sulfate, Amphetamine sulphate, Phenaminum, 60-13-9, Amphamine sulfate, Amphetamini sulfas
    Molecular Formula
    C18H28N2O4S
    Molecular Weight
    368.5  g/mol
    InChI Key
    PYHRZPFZZDCOPH-UHFFFAOYSA-N
    FDA UNII
    6DPV8NK46S
    Amphetamine
    Amphetamine Sulfate is the sulfate salt form of amphetamine, a synthetic substance related to natural sympathomimetic amines. Amphetamine appears to exert its central nervous system (CNS) and peripheral effects indirectly by inducing the release of biogenic amines from their storage sites in nerve terminals. This agent is a commonly abused psychostimulant drug, which may be snorted, taken orally, smoked, or injected. Amphetamine induces psychologic dependence which is manifested by elevated mood, increased wakefulness, concentration, physical performance and a feeling of well-being. With sustained use, the effects of tachycardia and enhanced alertness diminish while psychotoxic effects such as hallucinations and delusions may occur. (NCI04)
    1 2D Structure

    Amphetamine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-phenylpropan-2-amine;sulfuric acid
    2.1.2 InChI
    InChI=1S/2C9H13N.H2O4S/c2*1-8(10)7-9-5-3-2-4-6-9;1-5(2,3)4/h2*2-6,8H,7,10H2,1H3;(H2,1,2,3,4)
    2.1.3 InChI Key
    PYHRZPFZZDCOPH-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(CC1=CC=CC=C1)N.CC(CC1=CC=CC=C1)N.OS(=O)(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    6DPV8NK46S
    2.3 Synonyms
    2.3.1 Depositor-Supplied Synonyms

    1. Dl-amphetamine Sulfate

    2. Amphetamine Sulphate

    3. Phenaminum

    4. 60-13-9

    5. Amphamine Sulfate

    6. Amphetamini Sulfas

    7. Dl-phenamine Sulfate

    8. Dl-amphetamine Sulphate

    9. Amphetaminium Sulfuricum

    10. Desoxynorephedrine Sulfate

    11. (+-)-amphetamine Sulfate

    12. Dl-amphetamine Hydrogen Sulfate

    13. (+-)-phenisopropylamine Sulfate

    14. Amfetamine Sulfate

    15. Amphetamine Sulfate [usp]

    16. Dl-1-phenyl-2-aminopropane Sulfate

    17. (+-)-2-amino-1-phenylpropane Sulfate

    18. (+-)-alpha-methylphenethylamine Sulfate (2:1)

    19. 6dpv8nk46s

    20. 1-phenylpropan-2-amine Sulfate (2:1)

    21. Amphetamine Sulfate (usp)

    22. Fenopromin Sulfate

    23. Penamine (van)

    24. Ccris 3644

    25. 1-phenyl-2-aminopropane Sulfate

    26. Cerm 1767

    27. Razemisches Phenylaminopropansulfat

    28. Dl-alpha-methylphenethylamine Sulfate

    29. Einecs 200-457-8

    30. Unii-6dpv8nk46s

    31. Nsc 170999

    32. Dl-amphetamine Sulfate Salt

    33. Benzadrine

    34. Alpha-methylphenethylamine Sulfate, (+-)-

    35. Benzedrine (tn)

    36. Evekeo (tn)

    37. Evekeo Odt

    38. Rac-amphetamine Sulphate

    39. D-amphetamine Sulfate Salt

    40. Schembl41204

    41. Amphetamine Sulfate [mi]

    42. Dtxsid4020082

    43. Phenethylamine, Alpha-methyl-, Sulfate (2:1), (+-)-

    44. Chebi:51063

    45. Amfetamine Sulfate [mart.]

    46. Amphetamine Sulfate [vandf]

    47. Amfetamine Sulfate [who-dd]

    48. Bis{1-phenylpropan-2-amine} Sulfate

    49. Amfetamine Sulfate [ep Impurity]

    50. Amfetamine Sulfate [ep Monograph]

    51. Amphetamine Sulfate [orange Book]

    52. .beta.-phenylisopyropylaminesulfate

    53. Benzeneethanamine, Alpha-methyl-, Sulfate

    54. Amphetamine Sulfate [usp Monograph]

    55. Amfetamine Sulfate [incb:green List]

    56. Delcobese Component Amphetamine Sulfate

    57. D02074

    58. (+/-)-2-amino-1-phenylpropane Sulfate

    59. (+/-)-2-amino-1-phenylpropane Sulphate

    60. Amphetamine Sulfate Component Of Delcobese

    61. Q21270844

    62. (+/-)-.alpha.-methylphenethylamine Sulfate (2:1)

    63. (+/-)-.alpha.-methylphenethylamine Sulphate (2:1)

    64. Benzeneethanamine, .alpha.-methyl-, Sulfate (2:1), (+/-)-

    65. Benzeneethanamine, .alpha.-methyl-, Sulphate (2:1), (+/-)-

    66. Dl-amphetamine Sulfate Salt Solution, Drug Standard, 1.0 Mg/ml In Methanol

    67. 2-(tetrahydro-furan-2-yl)-n-(3-trifluoromethyl-phenyl)-succinamicacid

    68. 156-31-0

    2.3.2 Other Synonyms

    1. Amfetamine

    2. Mydrial

    3. Desoxynorephedrine

    4. L Amphetamine

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 368.5 g/mol
    Molecular Formula C18H28N2O4S
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count4
    Exact Mass368.17697855 g/mol
    Monoisotopic Mass368.17697855 g/mol
    Topological Polar Surface Area135 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity166
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3

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OLESEN GROUP","supplierCountry":"DENMARK","foreign_port":"NA","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"3500","totalValueFC":"19576.2","currency":"EUR","unitRateINR":"295400","date":"09-Apr-2022","totalValueINR":"1477000","totalValueInUsd":"19576.2","indian_port":"DELHI AIR","hs_no":"29214600","bill_no":"8214498","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"781, INDUSTRIAL AREA,,PHASE-II,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678300200,"product":"HYDROXYAMPHETAMINE HYDROBROMIDE (QTY: 2 X 200 MG, VALUE: USD278\/EACH)(FOC)","address":"P.NO. 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    26-Apr-2021
    06-Nov-2024
    KGS
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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    Drugs in Development

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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 Pharmaceuticals Inc., Receives ANDA Approval for Amphetamine Mixed Salts ER Capsules

    Details:

    Dextroamphetamine Sulfate is a non-catecholamine sympathomimetic amines with CNS stimulant activity. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.


    Lead Product(s): Amphetamine,Dextroamphetamine Saccharate,Amphetamine Aspartate

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

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 24, 2023

    Granules India

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    Granules India Limited

    India
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    Not Confirmed
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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) : Amphetamine,Dextroamphetamine Saccharate,Amphetamine Aspartate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Granules Pharmaceuticals Inc., Receives ANDA Approval for Amphetamine Mixed Salts ER Capsules

    Details : Dextroamphetamine Sulfate is a non-catecholamine sympathomimetic amines with CNS stimulant activity. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extr...

    Brand Name : Amphetamine-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 24, 2023

    Granules India

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    • Development Update
    • fda
    • EDQM
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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 Pharmaceuticals Receives ANDA Approval for Amphetamine Mixed Salts (IR Tablets)

    Details:

    FDA approved generic of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, for Attention Deficit Hyperactivity Disorder and Narcolepsy.


    Lead Product(s): Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine

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

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 30, 2021

    Granules India

    02

    Granules India Limited

    India
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    Not Confirmed
    • 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) : Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Granules Pharmaceuticals Receives ANDA Approval for Amphetamine Mixed Salts (IR Tablets)

    Details : FDA approved generic of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, for Attention Deficit Hyperactivity Disorder and Narcolepsy.

    Brand Name : Adderall-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 30, 2021

    Granules India

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    Lupin Receives FDA Approval for Generic Version of Adderall XR

    Details:

    Adderall XR-Generic is a combination product of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate & amphetamine sulfate. It is indicated for ADHD.


    Lead Product(s): Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine

    Therapeutic Area: Psychiatry/Psychology Brand Name: Adderall XR-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 21, 2024

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    03

    Lupin Ltd

    India
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    Duphat
    Not Confirmed

    Lupin Ltd

    India
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    Duphat
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Receives FDA Approval for Generic Version of Adderall XR

    Details : Adderall XR-Generic is a combination product of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate & amphetamine sulfate. It is indicated for ADHD.

    Brand Name : Adderall XR-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 21, 2024

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    Aytu BioPharma Partners with Lupin Canada For ADHD Drug Commercialization

    Details:

    The agreement aims for the distribution and supply for Aytu's Adzenys XR-ODT and Cotempla XR-ODT product lines for the treatment of ADHD in Canada.


    Lead Product(s): Amphetamine

    Therapeutic Area: Psychiatry/Psychology Brand Name: Adzenys XR-ODT

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Lupin Pharma Canada

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement October 01, 2024

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    Aytu BioPharma

    U.S.A
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    Aytu BioPharma

    U.S.A
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Lupin Pharma Canada

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Aytu BioPharma Partners with Lupin Canada For ADHD Drug Commercialization

    Details : The agreement aims for the distribution and supply for Aytu's Adzenys XR-ODT and Cotempla XR-ODT product lines for the treatment of ADHD in Canada.

    Brand Name : Adzenys XR-ODT

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 01, 2024

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    Tris Pharma Partners with Perigon Pharmacy 360 to Enhance Access to DYANAVEL® XR Tablets for the Treatment of Attention Deficit Hyperactivity Disorder

    Details:

    Tris Pharma and Perigon launched a direct-to-patient program, that allows patients and caregivers access to DYANAVEL XR (amphetamine) extended-release tablets through Perigon’s digital pharmacy and receive assistance and support to help navigate their treatment journey.


    Lead Product(s): Amphetamine

    Therapeutic Area: Psychiatry/Psychology Brand Name: Dyanavel XR

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Perigon Pharmacy 360

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership October 30, 2023

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    Tris Pharma Inc

    U.S.A
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    Lead Product(s) : Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Perigon Pharmacy 360

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Tris Pharma Partners with Perigon Pharmacy 360 to Enhance Access to DYANAVEL® XR Tablets for the ...

    Details : Tris Pharma and Perigon launched a direct-to-patient program, that allows patients and caregivers access to DYANAVEL XR (amphetamine) extended-release tablets through Perigon’s digital pharmacy and receive assistance and support to help navigate their ...

    Brand Name : Dyanavel XR

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    October 30, 2023

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    GRI Bio Enters into Asset Purchase Agreement with Aardvark Therapeutics, Inc. for the Sale of Legacy Asset, ADAIR

    Details:

    Under the agreement, Aardvark will acquire certain assets and intellectual property of the Company that pertain to ADAIR, a proprietary abuse-deterrent formulation of immediate release dextroamphetamine, for the development of certain follow-on pipeline programs.


    Lead Product(s): Amphetamine

    Therapeutic Area: Psychiatry/Psychology Brand Name: ADAIR

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: Aardvark Therapeutics

    Deal Size: $80.0 million Upfront Cash: Undisclosed

    Deal Type: Agreement August 23, 2023

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    GRI Bio

    U.S.A
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    Lead Product(s) : Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Aardvark Therapeutics

    Deal Size : $80.0 million

    Deal Type : Agreement

    DEALS_DEV arrow-down

    GRI Bio Enters into Asset Purchase Agreement with Aardvark Therapeutics, Inc. for the Sale of Lega...

    Details : Under the agreement, Aardvark will acquire certain assets and intellectual property of the Company that pertain to ADAIR, a proprietary abuse-deterrent formulation of immediate release dextroamphetamine, for the development of certain follow-on pipeline ...

    Brand Name : ADAIR

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    August 23, 2023

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    Aytu BioPharma Announces Exclusive Agreement with Medomie Pharma Ltd. to Commercialize Adzenys XR-ODT(R) and Cotempla XR-ODT(R) in Israel and the Palest...

    Details:

    Under the agreement, Medomie will commercialize Adzenys XR-ODT (amphetamine) and Cotempla XR-ODT (methylphenidate) in Israel and the Palestinian Authority.


    Lead Product(s): Amphetamine

    Therapeutic Area: Psychiatry/Psychology Brand Name: Adzenys XR

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Aytu BioPharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement July 31, 2023

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    07

    Medomie

    Israel
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    Medomie

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    Lead Product(s) : Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Aytu BioPharma

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Aytu BioPharma Announces Exclusive Agreement with Medomie Pharma Ltd. to Commercialize Adzenys XR-...

    Details : Under the agreement, Medomie will commercialize Adzenys XR-ODT (amphetamine) and Cotempla XR-ODT (methylphenidate) in Israel and the Palestinian Authority.

    Brand Name : Adzenys XR

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    July 31, 2023

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    Glenmark and Cediprof Announce Exclusive Distribution Agreement in the United States for U.S. FDA Approved Dextroamphetamine Saccharate, Amphetamine Asp...

    Details:

    Under the agreement, Glenmark will distribute Cediprof's FDA approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), the generic version of Adderall® Tablets.


    Lead Product(s): Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine

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

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Cediprof

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement March 09, 2023

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    08

    Glenmark Pharmaceuticals

    India
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    Glenmark Pharmaceuticals

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    Lead Product(s) : Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Cediprof

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Glenmark and Cediprof Announce Exclusive Distribution Agreement in the United States for U.S. FDA ...

    Details : Under the agreement, Glenmark will distribute Cediprof's FDA approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), the generic version...

    Brand Name : Adderall-Generic

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    March 09, 2023

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    XELSTRYM™ (dextroamphetamine) transdermal system, CII, to be revealed as available soon at the 2023 American Professional Society of ADHD and Related ...

    Details:

    Xelstrym™ (dextroamphetamine) is a first and only FDA-approved, once-daily central nervous system stimulant transdermal patch for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.


    Lead Product(s): Amphetamine

    Therapeutic Area: Psychiatry/Psychology Brand Name: Xelstrym

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 10, 2023

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    09

    Noven Pharmaceuticals

    U.S.A
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    Noven Pharmaceuticals

    U.S.A
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    Lead Product(s) : Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    XELSTRYM™ (dextroamphetamine) transdermal system, CII, to be revealed as available soon at the 2...

    Details : Xelstrym™ (dextroamphetamine) is a first and only FDA-approved, once-daily central nervous system stimulant transdermal patch for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.

    Brand Name : Xelstrym

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 10, 2023

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    Tris Pharma and Pediatrix Therapeutics Announce Expansion of Partnership to Commercialize Tris's ADHD Portfolio and Pipeline Products in China

    Details:

    Dyanavel XR oral suspension (amphetamine) is a CNS stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control used for the treatment of attention deficit hyperactivity disorder (ADHD) in people 6 years and older.


    Lead Product(s): Amphetamine

    Therapeutic Area: Psychiatry/Psychology Brand Name: Dyanavel XR

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Pediatrix Therapeutics

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership December 01, 2022

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    10

    Tris Pharma Inc

    U.S.A
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    Lead Product(s) : Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Pediatrix Therapeutics

    Deal Size : Undisclosed

    Deal Type : Partnership

    DEALS_DEV arrow-down

    Tris Pharma and Pediatrix Therapeutics Announce Expansion of Partnership to Commercialize Tris's A...

    Details : Dyanavel XR oral suspension (amphetamine) is a CNS stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control used for the treatment of attention deficit hyperactivity disorder (ADHD) in people 6 years a...

    Brand Name : Dyanavel XR

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    December 01, 2022

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG

    USFDA APPLICATION NUMBER - 17078

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG

    USFDA APPLICATION NUMBER - 17078

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG

    USFDA APPLICATION NUMBER - 17078

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    DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 1.25MG BASE/ML

    USFDA APPLICATION NUMBER - 204325

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 12.5MG BASE

    USFDA APPLICATION NUMBER - 204326

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 15.7MG BASE

    USFDA APPLICATION NUMBER - 204326

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 18.8MG BASE

    USFDA APPLICATION NUMBER - 204326

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 3.1MG BASE

    USFDA APPLICATION NUMBER - 204326

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 6.3MG BASE

    USFDA APPLICATION NUMBER - 204326

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 9.4MG BASE

    USFDA APPLICATION NUMBER - 204326

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    DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - 2MG/ML;EQ 0.5MG BASE/ML

    USFDA APPLICATION NUMBER - 208147

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG;EQ 3MG BASE

    USFDA APPLICATION NUMBER - 210526

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG;EQ 4MG BASE

    USFDA APPLICATION NUMBER - 210526

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;EQ 1MG BASE

    USFDA APPLICATION NUMBER - 210526

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;EQ 2MG BASE

    USFDA APPLICATION NUMBER - 210526

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.25MG;1.25MG;1.25MG;1.25MG

    USFDA APPLICATION NUMBER - 21303

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5MG;2.5MG;2.5MG;2.5MG

    USFDA APPLICATION NUMBER - 21303

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.7...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.75MG;3.75MG;3.75MG;3.75MG

    USFDA APPLICATION NUMBER - 21303

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG;5MG;5MG;5MG

    USFDA APPLICATION NUMBER - 21303

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.25MG;6.25MG;6.25MG;6.25MG

    USFDA APPLICATION NUMBER - 21303

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5MG;7.5MG;7.5MG;7.5MG

    USFDA APPLICATION NUMBER - 21303

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    ABOUT THIS PAGE

    Amphetamine Manufacturers

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

    Amphetamine Suppliers

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

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

    Amphetamine USDMF

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

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

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

    Amphetamine CEP

    A Amphetamine CEP of the European Pharmacopoeia monograph is often referred to as a Amphetamine Certificate of Suitability (COS). The purpose of a Amphetamine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amphetamine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amphetamine to their clients by showing that a Amphetamine CEP has been issued for it. The manufacturer submits a Amphetamine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amphetamine CEP holder for the record. Additionally, the data presented in the Amphetamine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amphetamine DMF.

    A Amphetamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amphetamine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Amphetamine suppliers with CEP (COS) on PharmaCompass.

    Amphetamine 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 Amphetamine as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Amphetamine GMP

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

    Amphetamine CoA

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

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

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