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Chemistry

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Also known as: Jzp-110 hydrochloride, 178429-65-7, Solriamfetol (hydrochloride), K7ro88sp7a, Solriamfetol hydrochloride [usan], Solriamfetol hydrochloride (usan)
Molecular Formula
C10H15ClN2O2
Molecular Weight
230.69  g/mol
InChI Key
KAOVAAHCFNYXNJ-SBSPUUFOSA-N
FDA UNII
K7RO88SP7A

Solriamfetol Hydrochloride
1 2D Structure

Solriamfetol Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(2R)-2-amino-3-phenylpropyl] carbamate;hydrochloride
2.1.2 InChI
InChI=1S/C10H14N2O2.ClH/c11-9(7-14-10(12)13)6-8-4-2-1-3-5-8;/h1-5,9H,6-7,11H2,(H2,12,13);1H/t9-;/m1./s1
2.1.3 InChI Key
KAOVAAHCFNYXNJ-SBSPUUFOSA-N
2.1.4 Canonical SMILES
C1=CC=C(C=C1)CC(COC(=O)N)N.Cl
2.1.5 Isomeric SMILES
C1=CC=C(C=C1)C[C@H](COC(=O)N)N.Cl
2.2 Other Identifiers
2.2.1 UNII
K7RO88SP7A
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (2r)-2-amino-3-phenylpropyl Carbamate

2. (r)-2-amino-3-phenylpropylcarbamate Hydrochloride

3. Adx-n05

4. Benzenepropanol, Beta-amino-, Carbamate (ester), (betar)-

5. Jzp-110

6. Solriamfetol

7. Sunosi

2.3.2 Depositor-Supplied Synonyms

1. Jzp-110 Hydrochloride

2. 178429-65-7

3. Solriamfetol (hydrochloride)

4. K7ro88sp7a

5. Solriamfetol Hydrochloride [usan]

6. Solriamfetol Hydrochloride (usan)

7. R-228060

8. Sunosi (tn)

9. Unii-k7ro88sp7a

10. Adx-n05 Hydrochloride

11. Ykp-10a Hydrochloride

12. Schembl8430382

13. Adx-n-05 Hydrochloride

14. Skl-n-05 Hydrochloride

15. Chembl4297212

16. Dtxsid101027927

17. R-228060 Hydrochloride

18. Hy-109043a

19. Solriamfetol Hydrochloride [mi]

20. Solriamfetol Hydrochloride [who-dd]

21. Cs-0112102

22. O-carbamoyl-(d)-phenylalaninol Hydrochloride

23. D11328

24. Solriamfetol Hydrochloride [orange Book]

25. (d)-o-carbamoylphenylalaninol Hydrochloride Salt

26. R228060;jzp-110;adx-n05;skl-n05;ykp-10

27. (2r)-2-amino-3-phenylpropyl Carbamate, Monohydrochloride

28. (betar)-beta-amino-benzenepropanol 1-carbamate Hydrochloride (1:1)

29. (r)-(+)-2-amino-1-carbamoyloxy-3-phenylpropane Hydrochloride

30. Benzenepropanol, .beta.-amino-, 1-carbamate, Hydrochloride (1:1), (.beta.r)-

31. 561069-23-6

2.4 Create Date
2012-11-30
3 Chemical and Physical Properties
Molecular Weight 230.69 g/mol
Molecular Formula C10H15ClN2O2
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count3
Rotatable Bond Count5
Exact Mass230.0822054 g/mol
Monoisotopic Mass230.0822054 g/mol
Topological Polar Surface Area78.3 Ų
Heavy Atom Count15
Formal Charge0
Complexity179
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy).

Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).


5 Pharmacology and Biochemistry
5.1 ATC Code

N06BA14


API SUPPLIERS

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Inke S.A

Spain

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Virtual BoothInke S.A: APIs manufacturing plant.

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Egis Pharmaceuticals PLC

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Hikma Pharmaceuticals

United Kingdom

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Hikma Pharmaceuticals

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Alkem Laboratories

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Hetero Drugs

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Aurobindo Pharma Limited

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Alivus Life Sciences

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Unichem Laboratories Limited

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Glenmark Pharmaceuticals

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USDMF

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GDUFA

DMF Review : Complete

Rev. Date : 2022-12-16

Pay. Date : 2022-11-14

DMF Number : 34741

Submission : 2020-03-31

Status : Active

Type : II

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GDUFA

DMF Review : Complete

Rev. Date : 2023-02-15

Pay. Date : 2023-02-03

DMF Number : 36951

Submission : 2022-03-28

Status : Active

Type : II

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DMF Review : Complete

Rev. Date : 2023-04-28

Pay. Date : 2023-01-09

DMF Number : 37929

Submission : 2023-01-10

Status : Active

Type : II

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Hetero Drugs Ltd

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DMF Review : Complete

Rev. Date : 2023-05-16

Pay. Date : 2023-04-12

DMF Number : 38280

Submission : 2023-04-18

Status : Active

Type : II

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Hikma Pharmaceuticals Llc

United Kingdom

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DMF Review : Complete

Rev. Date : 2023-04-04

Pay. Date : 2022-12-19

DMF Number : 37548

Submission : 2022-12-28

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DMF Review : Complete

Rev. Date : 2023-03-16

Pay. Date : 2023-01-25

DMF Number : 36949

Submission : 2022-03-30

Status : Active

Type : II

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Drugs in Development

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Details:

Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is being evaluated for major depressive disorder (MDD) with and without severe excessive daytime sleepiness.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Sunosi

Study Phase: Phase IIIProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 01, 2025

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01

German Wound Congress
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German Wound Congress
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Details : Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is being evaluated for major depressive disorder (MDD) with and without severe excessive daytime sleepiness.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

April 01, 2025

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Details:

Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is being evaluated for the treatment of attention deficit hyperactivity disorder.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Sunosi

Study Phase: Phase IIIProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 25, 2025

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02

German Wound Congress
Not Confirmed
German Wound Congress
Not Confirmed

Details : Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is being evaluated for the treatment of attention deficit hyperactivity disorder.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

March 25, 2025

blank

Details:

Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Sleep Brand Name: Sunosi

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 29, 2024

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03

German Wound Congress
Not Confirmed
German Wound Congress
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Details : Sunosi (solriamfetol hcl) is a dopamine and norepinephrine reuptake inhibitor. It is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

May 29, 2024

blank

Details:

Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. It is being evaluated for the treatment of major depressive disorder.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Sunosi

Study Phase: Phase IIIProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 19, 2024

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04

German Wound Congress
Not Confirmed
German Wound Congress
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Details : Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. It is being evaluated for the treatment of major depressive disorder.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

March 19, 2024

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Details:

Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. It is being evaluated for the treatment of binge eating disorder.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Sunosi

Study Phase: Phase IIIProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 04, 2024

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05

German Wound Congress
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German Wound Congress
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Details : Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist. It is being evaluated for the treatment of binge eating disorder.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

January 04, 2024

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Details:

Sunosi (solriamfetol), is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with Attention Deficit Hyperactivity Disorder (ADHD) in Adults.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Sunosi

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 07, 2023

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06

German Wound Congress
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German Wound Congress
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Details : Sunosi (solriamfetol), is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with Attention Deficit Hyperactivity Disorder (ADHD) in Adults.

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

July 07, 2023

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Details:

Under the agreement, Pharmanovia will be responsible for the development and marketing of Sunosi (solriamfetol), a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults with EDS due to narcolepsy or OSA, in Europe and MENA regions.


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Sleep Brand Name: Sunosi

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Pharmanovia

Deal Size: $167.0 million Upfront Cash: $66.0 million

Deal Type: Licensing Agreement February 22, 2023

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German Wound Congress
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German Wound Congress
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Details : Under the agreement, Pharmanovia will be responsible for the development and marketing of Sunosi (solriamfetol), a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults with EDS due to narcolepsy or OSA, in Eur...

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : $66.0 million

February 22, 2023

blank

Details:

Sunosi (solriamfetol), is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Sleep Brand Name: Sunosi

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Axsome Therapeutics

Deal Size: Undisclosed Upfront Cash: $53.0 million

Deal Type: Divestment September 05, 2022

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08

German Wound Congress
Not Confirmed
German Wound Congress
Not Confirmed

Details : Sunosi (solriamfetol), is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : $53.0 million

September 05, 2022

blank

Details:

Sunosi (solriamfetol) is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Sleep Brand Name: Sunosi

Study Phase: Phase IVProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 09, 2022

blank

09

German Wound Congress
Not Confirmed
German Wound Congress
Not Confirmed

Details : Sunosi (solriamfetol) is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

July 09, 2022

blank

Details:

Sunosi (solriamfetol) is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).


Lead Product(s): Solriamfetol Hydrochloride

Therapeutic Area: Sleep Brand Name: Sunosi

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 28, 2022

blank

10

German Wound Congress
Not Confirmed
German Wound Congress
Not Confirmed

Details : Sunosi (solriamfetol) is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA).

Product Name : Sunosi

Product Type : Controlled Substance

Upfront Cash : Inapplicable

June 28, 2022

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FDF Dossiers

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ATNAHS PHARMA UK LIMITED

United Kingdom
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ATNAHS PHARMA UK LIMITED

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Solriamfetol hydrochloride

Brand Name : Sunosi

Dosage Form : Tablet, film-coated

Dosage Strength : 75 mg

Packaging : Blisterpakning 28item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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ATNAHS PHARMA UK LIMITED

United Kingdom
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ATNAHS PHARMA UK LIMITED

United Kingdom
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Solriamfetol hydrochloride

Brand Name : Sunosi

Dosage Form : Tablet, film-coated

Dosage Strength : 150 mg

Packaging : Blisterpakning 28item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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SOLRIAMFETOL HYDROCHLORIDE

Brand Name : SUNOSI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Packaging :

Approval Date : 2019-06-17

Application Number : 211230

Regulatory Info : RX

Registration Country : USA

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SOLRIAMFETOL HYDROCHLORIDE

Brand Name : SUNOSI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Packaging :

Approval Date : 2019-06-17

Application Number : 211230

Regulatory Info : RX

Registration Country : USA

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Hetero Drugs

India
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Hetero Drugs

India
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SOLRIAMFETOL

Brand Name : SOLRIAMFETOL

Dosage Form : TABLET

Dosage Strength : 300MG

Packaging :

Approval Date :

Application Number : 218654

Regulatory Info :

Registration Country : USA

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Hetero Drugs

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Hetero Drugs

India
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SOLRIAMFETOL

Brand Name : SOLRIAMFETOL

Dosage Form : TABLET

Dosage Strength : 75MG

Packaging :

Approval Date :

Application Number : 218654

Regulatory Info :

Registration Country : USA

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Hetero Drugs

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Hetero Drugs

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SOLRIAMFETOL

Brand Name : SOLRIAMFETOL

Dosage Form : TABLET

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number : 218654

Regulatory Info :

Registration Country : USA

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FDA Orange Book

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AXSOME MALTA

U.S.A
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AXSOME MALTA

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SOLRIAMFETOL HYDROCHLORIDE

Brand Name : SUNOSI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 75MG BASE

Approval Date : 2019-06-17

Application Number : 211230

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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AXSOME MALTA

U.S.A
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AXSOME MALTA

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SOLRIAMFETOL HYDROCHLORIDE

Brand Name : SUNOSI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2019-06-17

Application Number : 211230

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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SOLRIAMFETOL

Brand Name : SOLRIAMFETOL

Dosage Form : TABLET

Dosage Strength : 300MG

Approval Date :

Application Number : 218654

RX/OTC/DISCN :

RLD :

TE Code :

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SOLRIAMFETOL

Brand Name : SOLRIAMFETOL

Dosage Form : TABLET

Dosage Strength : 75MG

Approval Date :

Application Number : 218654

RX/OTC/DISCN :

RLD :

TE Code :

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SOLRIAMFETOL

Brand Name : SOLRIAMFETOL

Dosage Form : TABLET

Dosage Strength : 150MG

Approval Date :

Application Number : 218654

RX/OTC/DISCN :

RLD :

TE Code :

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Solriamfetol Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Solriamfetol Hydrochloride

Synonyms

Jzp-110 hydrochloride, 178429-65-7, Solriamfetol (hydrochloride), K7ro88sp7a, Solriamfetol hydrochloride [usan], Solriamfetol hydrochloride (usan)

Cas Number

178429-65-7

Unique Ingredient Identifier (UNII)

K7RO88SP7A

Solriamfetol Hydrochloride Manufacturers

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

Solriamfetol Hydrochloride Suppliers

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

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

Solriamfetol Hydrochloride USDMF

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

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

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

Solriamfetol Hydrochloride WC

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

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

Solriamfetol Hydrochloride 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 Solriamfetol Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Solriamfetol Hydrochloride GMP

Solriamfetol Hydrochloride 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 Solriamfetol Hydrochloride 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 Solriamfetol Hydrochloride GMP manufacturer or Solriamfetol Hydrochloride GMP API supplier for your needs.

Solriamfetol Hydrochloride CoA

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

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

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