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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

    API Reference Price

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    08-Mar-2021
    27-Mar-2025
    KGS
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    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 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,Amphetamine Aspartate,Dextroamphetamine Saccharate

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

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 24, 2023

    Granules India

    01

    Granules India Limited

    India
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    Attending
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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,Amphetamine Aspartate,Dextroamphetamine Saccharate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    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...

    Product Name : Amphetamine-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 24, 2023

    Granules India

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    • 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: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 30, 2021

    Granules India

    02

    Granules India Limited

    India
    arrow
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    Attending
    • 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 FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    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.

    Product Name : Adderall-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    December 30, 2021

    Granules India

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    Glenmark to Launch Generic Version of Adderall Tablets in the US Market by May 2025

    Details:

    Adderall-Generic is a CNS stimulant, which is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and Narcolepsy.


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

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

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 17, 2025

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    03

    Glenmark Pharmaceuticals

    India
    arrow
    AACR Annual meeting
    Not Confirmed

    Glenmark Pharmaceuticals

    India
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    AACR Annual meeting
    Not Confirmed
    • fda
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    • WHO-GMP
    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 FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Glenmark to Launch Generic Version of Adderall Tablets in the US Market by May 2025

    Details : Adderall-Generic is a CNS stimulant, which is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and Narcolepsy.

    Product Name : Adderall-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    April 17, 2025

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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: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 21, 2024

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    04

    Lupin Ltd

    India
    arrow
    AACR Annual meeting
    Not Confirmed

    Lupin Ltd

    India
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    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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 FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    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.

    Product Name : Adderall XR-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    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: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Lupin Pharma Canada

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement January 10, 2024

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    05

    Aytu BioPharma

    U.S.A
    arrow
    AACR Annual meeting
    Not Confirmed

    Aytu BioPharma

    U.S.A
    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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 FDF

    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.

    Product Name : Adzenys XR-ODT

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    January 10, 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: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Perigon Pharmacy 360

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership October 30, 2023

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    06

    Tris Pharma Inc

    U.S.A
    arrow
    AACR Annual meeting
    Not Confirmed

    Tris Pharma Inc

    U.S.A
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    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) : Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    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 ...

    Product Name : Dyanavel XR

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    October 30, 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: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 01, 2023

    blank

    07

    Noven Pharmaceuticals

    U.S.A
    arrow
    AACR Annual meeting
    Not Confirmed

    Noven Pharmaceuticals

    U.S.A
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    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) : Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    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.

    Product Name : Xelstrym

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 01, 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: Approved FDFProduct Type: Controlled Substance

    Sponsor: Cediprof

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement September 03, 2023

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    08

    Glenmark Pharmaceuticals

    India
    arrow
    AACR Annual meeting
    Not Confirmed

    Glenmark Pharmaceuticals

    India
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    AACR Annual meeting
    Not Confirmed
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    • WHO-GMP
    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 FDF

    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...

    Product Name : Adderall-Generic

    Product Type : Controlled Substance

    Upfront Cash : Undisclosed

    September 03, 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: Other Small Molecule

    Sponsor: Aardvark Therapeutics

    Deal Size: $80.0 million Upfront Cash: Undisclosed

    Deal Type: Agreement August 23, 2023

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    09

    GRI Bio

    U.S.A
    arrow
    AACR Annual meeting
    Not Confirmed

    GRI Bio

    U.S.A
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    AACR Annual meeting
    Not Confirmed
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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 ...

    Product Name : ADAIR

    Product Type : Other 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: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Aytu BioPharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement July 31, 2023

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    10

    Medomie

    Israel
    arrow
    AACR Annual meeting
    Not Confirmed

    Medomie

    Israel
    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
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    Lead Product(s) : Amphetamine

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    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.

    Product Name : Adzenys XR

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    July 31, 2023

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    FDF Dossiers

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    01

    Aspen Pharmacare Holdings

    South Africa
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    Not Confirmed
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    Flag South Africa
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Australia

    Dexamfetamine

    Brand Name : Aspen Pharmacare Australia Pty Ltd

    Dosage Form :

    Dosage Strength :

    Packaging : 100

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

    Aspen API Comapny Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : DISCN

    Registration Country : USA

    DEXTROAMPHETAMINE SULFATE

    Brand Name : DEXTROAMPHETAMINE SULFATE

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2002-01-18

    Application Number : 76137

    Regulatory Info : DISCN

    Registration Country : USA

    Dr Reddy Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : DISCN

    Registration Country : USA

    DEXTROAMPHETAMINE SULFATE

    Brand Name : DEXTROAMPHETAMINE SULFATE

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2002-01-18

    Application Number : 76137

    Regulatory Info : DISCN

    Registration Country : USA

    Dr Reddy Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    04

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : DISCN

    Registration Country : USA

    DEXTROAMPHETAMINE SULFATE

    Brand Name : DEXTROAMPHETAMINE SULFATE

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 15MG

    Packaging :

    Approval Date : 2002-01-18

    Application Number : 76137

    Regulatory Info : DISCN

    Registration Country : USA

    Dr Reddy Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    05

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : DISCN

    Registration Country : USA

    AMPHETAMINE SULFATE

    Brand Name : AMPHETAMINE SULFATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2020-07-14

    Application Number : 213898

    Regulatory Info : DISCN

    Registration Country : USA

    Dr Reddy Company Banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

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    Website

    Corporate PDF

    06

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : DISCN

    Registration Country : USA

    AMPHETAMINE SULFATE

    Brand Name : AMPHETAMINE SULFATE

    Dosage Form : TABLET;ORAL

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    Approval Date : 2020-07-14

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    Approval Date : 2019-06-21

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    Dosage Strength : 10MG

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    Approval Date : 2017-10-31

    Application Number : 205673

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    Brand Name : DEXTROAMPHETAMINE SULFATE

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

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    Approval Date : 2017-10-31

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    AA PHARMA INC

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    DEXTROAMPHETAMINE SULFATE

    Brand Name : DEXTROAMPHETAMINE

    Dosage Form : TABLET

    Dosage Strength : 5MG

    Packaging : 100/500

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    Application Number : 2443236

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    Application Number : 2448319

    Regulatory Info : Schedule G (CDSA I)

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    Application Number : 2448327

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    Application Number : 1924567

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    Approval Date :

    Application Number : 1924559

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    Application Number : 1924516

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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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    01

    AZURITY

    AMPHETAMINE SULFATE

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    AACR Annual meeting
    Not Confirmed

    AZURITY

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Patent Expiration Date : 2037-03-10

    AMPHETAMINE SULFATE

    US Patent Number : 10441554

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 209905

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2037-03-10

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    AZURITY

    AMPHETAMINE SULFATE

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    Not Confirmed

    AZURITY

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Patent Expiration Date : 2037-03-10

    AMPHETAMINE SULFATE

    US Patent Number : 11160772

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 209905

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2037-03-10

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    NEOS THERAPS

    AMPHETAMINE

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    Not Confirmed

    NEOS THERAPS

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Patent Expiration Date : 2032-06-28

    AMPHETAMINE

    US Patent Number : 8709491

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204326

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2032-06-28

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    NEOS THERAPS

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    Not Confirmed

    NEOS THERAPS

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Patent Expiration Date : 2026-04-09

    AMPHETAMINE

    US Patent Number : 8840924

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204326

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2026-04-09

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    NEOS THERAPS INC

    AMPHETAMINE

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    AACR Annual meeting
    Not Confirmed

    NEOS THERAPS INC

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Patent Expiration Date : 2032-06-28

    AMPHETAMINE

    US Patent Number : 8709491

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204325

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2032-06-28

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    06

    NEOS THERAPS

    AMPHETAMINE

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    AACR Annual meeting
    Not Confirmed

    NEOS THERAPS

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Patent Expiration Date : 2032-06-28

    AMPHETAMINE

    US Patent Number : 9839619

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204326

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2032-06-28

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    07

    NEOS THERAPS

    AMPHETAMINE

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    AACR Annual meeting
    Not Confirmed

    NEOS THERAPS

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Patent Expiration Date : 2032-06-28

    AMPHETAMINE

    US Patent Number : 8709491

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204326

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2032-06-28

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    08

    NOVEN PHARMS INC

    DEXTROAMPHETAMINE

    arrow
    AACR Annual meeting
    Not Confirmed

    NOVEN PHARMS INC

    U.S.A
    arrow
    AACR Annual meeting
    Not Confirmed

    Patent Expiration Date : 2033-10-24

    DEXTROAMPHETAMINE

    US Patent Number : 9456993

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 215401

    Patent Use Code : U-3340

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2033-10-24

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    09

    TRIS PHARMA INC

    AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

    arrow
    AACR Annual meeting
    Not Confirmed

    TRIS PHARMA INC

    U.S.A
    arrow
    AACR Annual meeting
    Not Confirmed

    Patent Expiration Date : 2027-03-15

    AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

    US Patent Number : 8747902

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 210526

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2027-03-15

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    10

    TRIS PHARMA INC

    AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

    arrow
    AACR Annual meeting
    Not Confirmed

    TRIS PHARMA INC

    U.S.A
    arrow
    AACR Annual meeting
    Not Confirmed

    Patent Expiration Date : 2027-03-15

    AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

    US Patent Number : 8883217

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 208147

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2027-03-15

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    US Exclusivities

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    NOVEN PHARMS INC

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    NP
    2025-03-22
    215401
    1
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    01

    NOVEN PHARMS INC

    DEXTROAMPHETAMINE

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    AACR Annual meeting
    Not Confirmed

    NOVEN PHARMS INC

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    DEXTROAMPHETAMINE

    Exclusivity Code : NP

    Exclusivity Expiration Date : 2025-03-22

    Application Number : 215401

    Product Number : 1

    Exclusivity Details :

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    NOVEN PHARMS INC

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    ABOUT THIS PAGE

    Looking for 156-31-0 / Amphetamine API manufacturers, exporters & distributors?

    Amphetamine manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Amphetamine

    Synonyms

    Dl-amphetamine sulfate, Amphetamine sulphate, Phenaminum, 60-13-9, Amphamine sulfate, Amphetamini sulfas

    Cas Number

    156-31-0

    Unique Ingredient Identifier (UNII)

    6DPV8NK46S

    About 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)

    Benzedrine sulfate Manufacturers

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

    Benzedrine sulfate Suppliers

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

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

    Benzedrine sulfate USDMF

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

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

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

    Benzedrine sulfate CEP

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

    A Benzedrine sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Benzedrine sulfate 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 Benzedrine sulfate suppliers with CEP (COS) on PharmaCompass.

    Benzedrine sulfate 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 Benzedrine sulfate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Benzedrine sulfate GMP

    Benzedrine sulfate 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 Benzedrine sulfate 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 Benzedrine sulfate GMP manufacturer or Benzedrine sulfate GMP API supplier for your needs.

    Benzedrine sulfate CoA

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

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

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