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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
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
Molecular Weight | 230.69 g/mol |
---|---|
Molecular Formula | C10H15ClN2O2 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 3 |
Rotatable Bond Count | 5 |
Exact Mass | 230.0822054 g/mol |
Monoisotopic Mass | 230.0822054 g/mol |
Topological Polar Surface Area | 78.3 Ų |
Heavy Atom Count | 15 |
Formal Charge | 0 |
Complexity | 179 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
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).
N06BA14
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-04
Pay. Date : 2022-12-19
DMF Number : 37548
Submission : 2022-12-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-02-15
Pay. Date : 2023-02-03
DMF Number : 36951
Submission : 2022-03-28
Status : Active
Type : II
Date of Issue : 2022-07-23
Valid Till : 2025-09-05
Written Confirmation Number : WC-0385
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-16
Pay. Date : 2023-04-12
DMF Number : 38280
Submission : 2023-04-18
Status : Active
Type : II
NDC Package Code : 65977-0140
Start Marketing Date : 2019-12-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-28
Pay. Date : 2023-01-09
DMF Number : 37929
Submission : 2023-01-10
Status : Active
Type : II
NDC Package Code : 59651-756
Start Marketing Date : 2023-11-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-12-16
Pay. Date : 2022-11-14
DMF Number : 34741
Submission : 2020-03-31
Status : Active
Type : II
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm :
NDC Package Code : 66039-953
Start Marketing Date : 2020-09-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-16
Pay. Date : 2023-01-25
DMF Number : 36949
Submission : 2022-03-30
Status : Active
Type : II
NDC Package Code : 53747-100
Start Marketing Date : 2022-03-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
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
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-28
Pay. Date : 2023-01-09
DMF Number : 37929
Submission : 2023-01-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-16
Pay. Date : 2023-04-12
DMF Number : 38280
Submission : 2023-04-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-04
Pay. Date : 2022-12-19
DMF Number : 37548
Submission : 2022-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-16
Pay. Date : 2023-01-25
DMF Number : 36949
Submission : 2022-03-30
Status : Active
Type : II
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
Lead Product(s) : Solriamfetol Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Axsome Reports PARADIGM Ph 3 Results Of Solriamfetol in MDD wth/without EDS
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
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
Lead Product(s) : Solriamfetol Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Axsome’s Phase 3 FOCUS Trial of Solriamfetol in ADHD Meets Endpoint
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
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
Lead Product(s) : Solriamfetol Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Axsome Highlights Data on Solriamfetol Showing Cognitive Improvement in Narcolepsy
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
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
Lead Product(s) : Solriamfetol Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Axsome Initiates PARADIGM Phase 3 Of Solriamfetol For Major Depressive Disorder Treatment
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
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
Lead Product(s) : Solriamfetol Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Axsome Initiates ENGAGE Phase 3 Trial of Solriamfetol for Binge Eating Disorder
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
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
Lead Product(s) : Solriamfetol Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Solriamfetol Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pharmanovia
Deal Size : $167.0 million
Deal Type : Licensing Agreement
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
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
Lead Product(s) : Solriamfetol Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Axsome Therapeutics
Deal Size : Undisclosed
Deal Type : Divestment
Jazz Pharmaceuticals Completes U.S. Divestiture of Sunosi® (solriamfetol) to Axsome Therapeutics
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
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
Lead Product(s) : Solriamfetol Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Axsome Therapeutics Announces Publication of Post-hoc Analysis of Sunosi® Effect on Excessive Day...
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
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
Lead Product(s) : Solriamfetol Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Axsome Therapeutics Hosts Sunosi® Investor Update Virtual Event Today with Key Opinion Leaders
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
Regulatory Info :
Registration Country : Norway
Brand Name : Sunosi
Dosage Form : Tablet, film-coated
Dosage Strength : 75 mg
Packaging : Blisterpakning 28item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Sunosi
Dosage Form : Tablet, film-coated
Dosage Strength : 150 mg
Packaging : Blisterpakning 28item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info :
Registration Country : USA
Brand Name : SOLRIAMFETOL
Dosage Form : TABLET
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number : 218654
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : SOLRIAMFETOL
Dosage Form : TABLET
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number : 218654
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : SOLRIAMFETOL
Dosage Form : TABLET
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number : 218654
Regulatory Info :
Registration Country : USA
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD :
TE Code :
Brand Name : SOLRIAMFETOL
Dosage Form : TABLET
Dosage Strength : 300MG
Approval Date :
Application Number : 218654
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : SOLRIAMFETOL
Dosage Form : TABLET
Dosage Strength : 75MG
Approval Date :
Application Number : 218654
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : SOLRIAMFETOL
Dosage Form : TABLET
Dosage Strength : 150MG
Approval Date :
Application Number : 218654
RX/OTC/DISCN :
RLD :
TE Code :
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ABOUT THIS PAGE
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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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).