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1. (4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl)(5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl)methanone
2. Belsomra
3. Methanone, ((7r)-4-(5-chloro-2-benzoxazolyl)hexahydro-7-methyl-1h-1,4-diazepin-1-yl)(5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl)-
4. Mk 4305
5. Mk-4305
6. Mk4305
1. 1030377-33-3
2. Mk-4305
3. Belsomra
4. Mk4305
5. Mk 4305
6. [(7r)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl]methanone
7. Suvorexant (mk-4305)
8. 5-chloro-2-[(5r)-5-methyl-4-[5-methyl-2-(2h-1,2,3-triazol-2-yl)benzoyl]-1,4-diazepan-1-yl]-1,3-benzoxazole
9. Chembl1083659
10. Chebi:82698
11. 081l192fo9
12. ((7r)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl)(5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl)methanone
13. Methanone, ((7r)-4-(5-chloro-2-benzoxazolyl)hexahydro-7-methyl-1h-1,4-diazepin-1-yl)(5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl)-
14. (r)-(4-(5-chlorobenzo[d]oxazol-2-yl)-7-methyl-1,4-diazepan-1-yl)(5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl)methanone.
15. [(7r)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl]-[5-methyl-2-(triazol-2-yl)phenyl]methanone
16. Suvorexant [usan:inn]
17. Dora-analogue
18. Unii-081l192fo9
19. Belsomra (tn)
20. Suv
21. Suvorexant [mi]
22. Suvorexant [inn]
23. Suvorexant [jan]
24. Suvorexant (jan/usan)
25. Suvorexant [usan]
26. Suvorexant; Mk 4305
27. Suvorexant [vandf]
28. Suvorexant [who-dd]
29. Amy337
30. Gtpl2890
31. Schembl1586289
32. Suvorexant [orange Book]
33. Dtxsid90145616
34. Ex-a211
35. Belsomra Component Suvorexant
36. Bdbm50318701
37. Mfcd22377755
38. Zinc49036447
39. Akos022185167
40. Cs-0614
41. Db09034
42. Suvorexant Component Of Belsomra
43. (4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl)(5-methyl-2-(2h-1,2,3-triazol-2-yl)phenyl)methanone
44. Ac-30276
45. As-74879
46. Hy-10807
47. Bcp0726000197
48. Ft-0697203
49. Sw219649-1
50. D10082
51. J-690010
52. Q7650517
53. Cas:1030377-33-3;mk-4305
54. 5-chloro-2-[(5r)-5-methyl-4-[5-methyl-2-(2h-1,2,3-triazol-2-yl)benzoyl]-1,4-diazepan-1-yl]-1,3-benzoxazole Mk 4305
| Molecular Weight | 450.9 g/mol |
|---|---|
| Molecular Formula | C23H23ClN6O2 |
| XLogP3 | 4.9 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 3 |
| Exact Mass | 450.1571017 g/mol |
| Monoisotopic Mass | 450.1571017 g/mol |
| Topological Polar Surface Area | 80.3 Ų |
| Heavy Atom Count | 32 |
| Formal Charge | 0 |
| Complexity | 664 |
| 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 | 1 |
Suvorexant is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
FDA Label
Orexin Receptor Antagonists
Substances that bind to and inhibit the action of OREXIN RECEPTORS. Drugs in this class have been used as SLEEP AIDS, PHARMACEUTICAL. (See all compounds classified as Orexin Receptor Antagonists.)
Sleep Aids, Pharmaceutical
Drugs used to induce SLEEP, prevent SLEEPLESSNESS, or treat SLEEP INITIATION AND MAINTENANCE DISORDERS. (See all compounds classified as Sleep Aids, Pharmaceutical.)
N - Nervous system
N05 - Psycholeptics
N05C - Hypnotics and sedatives
N05CM - Other hypnotics and sedatives
N05CM19 - Suvorexant
Absorption
Peak concentrations occur at a median Tmax of 2 hours under fasted conditions. Ingestion of suvorexant with a high-fat meal has no effect on AUC or Cmax, but may delay Tmax by approximately 1.5 hours. Mean absolute bioavailability of 10 mg is 82%.
Route of Elimination
Approximately 66% is eliminated in feces and 23% is eliminated in urine.
Volume of Distribution
Mean volume of distribution is approximately 49 litres.
Suvorexant is primarily metabolized by cytochrome-P450 3A4 enzyme (CYP3A4) with a minor contribution from CYP2C19. Major circulating metabolites are suvorexant and a hydroxy-suvorexant metabolite, which is not expected to be pharmacologically active. There is potential for drug-drug interactions with drugs that inhibit or induce CYP3A4 activity.
Mean half life is approximately 12 hours.
Suvorexant is a dual antagonist of orexin receptors OX1R and OX2R. It exerts its pharmacological effect by inhibiting binding of neuropeptides orexin A and B, also known as hypocretin 1 and 2, that are produced by neurons in the lateral hypothalamus. These neurons control the wake-promoting centers of the brain and are active during wakefulness, especially during motor activities, and stop firing during sleep. By inhibiting the reinforcement of arousal systems, suvorexant use causes a decrease in arousal and wakefulness, rather than having a direct sleep-promoting effect.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40216
Submission : 2024-08-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41519
Submission : 2025-03-19
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2023-11-27
Pay. Date : 2023-10-26
DMF Number : 38929
Submission : 2023-10-25
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41054
Submission : 2024-12-30
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 70966-0034
Start Marketing Date : 2014-08-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 50473-0029
Start Marketing Date : 2012-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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Details:
Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Alcoholism.
Lead Product(s): Suvorexant,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: University of California, Los Angeles | University of Texas Health Science Center at Houston
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 07, 2024

Lead Product(s) : Suvorexant,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : University of California, Los Angeles | University of Texas Health Science Center at Houston
Deal Size : Inapplicable
Deal Type : Inapplicable
Suvorexant for Treatment of AUD and PTSD
Details : Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Alcoholism.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 07, 2024

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Details:
Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Sleep Initiation and Maintenance Disorders.
Lead Product(s): Suvorexant,Inapplicable
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 24, 2024

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Lead Product(s) : Suvorexant,Inapplicable
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Sleep Initiation and Maintenance Disorders.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 24, 2024

Details:
Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Suvorexant,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Merck & Co
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 08, 2023

Lead Product(s) : Suvorexant,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 08, 2023

Details:
Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Sleep Initiation and Maintenance Disorders.
Lead Product(s): Suvorexant,Inapplicable
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Merck & Co
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 18, 2023

Lead Product(s) : Suvorexant,Inapplicable
Therapeutic Area : Sleep
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Insomnia Treatment and EMA (ecological Momentary Assessment) Outcomes
Details : Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Sleep Initiation and Maintenance Disorders.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 18, 2023

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Details:
Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Postoperative Insomnia.
Lead Product(s): Suvorexant,Inapplicable
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Merck & Co
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 21, 2023

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Lead Product(s) : Suvorexant,Inapplicable
Therapeutic Area : Sleep
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy of Suvorexant on Post-operative Sleep Disturbance
Details : Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Postoperative Insomnia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 21, 2023

Details:
Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Delirium.
Lead Product(s): Suvorexant,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Merck & Co
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 17, 2023

Lead Product(s) : Suvorexant,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant
Details : Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Delirium.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 17, 2023

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Details:
Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Substance-Related Disorders.
Lead Product(s): Suvorexant,Zolpidem Tartrate
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 03, 2021

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Lead Product(s) : Suvorexant,Zolpidem Tartrate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem
Details : Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Substance-Related Disorders.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 03, 2021

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Details:
Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Restless Legs Syndrome.
Lead Product(s): Suvorexant,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Merck & Co
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 12, 2021

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Lead Product(s) : Suvorexant,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Restless Legs Syndrome.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 12, 2021

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Details:
Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Sleep.
Lead Product(s): Suvorexant,Inapplicable
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Good Ventures | Merck & Co
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 16, 2020

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Lead Product(s) : Suvorexant,Inapplicable
Therapeutic Area : Sleep
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Good Ventures | Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
Sleep Trial to Prevent Alzheimer's Disease
Details : Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Sleep.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 16, 2020

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Details:
Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Delirium.
Lead Product(s): Suvorexant,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 01, 2020

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Lead Product(s) : Suvorexant,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Suvorexant is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Delirium.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 01, 2020

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RLD : Yes
TE Code :
Brand Name : BELSOMRA
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date : 2014-08-13
Application Number : 204569
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : BELSOMRA
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2014-08-13
Application Number : 204569
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : BELSOMRA
Dosage Form : TABLET;ORAL
Dosage Strength : 15MG
Approval Date : 2014-08-13
Application Number : 204569
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : BELSOMRA
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Approval Date : 2014-08-13
Application Number : 204569
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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Patents & EXCLUSIVITIES
Patent Expiration Date : 2033-05-29
US Patent Number : 10098892
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 204569
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-05-29

Patent Expiration Date : 2033-05-29
US Patent Number : 11980623
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 204569
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-05-29

Patent Expiration Date : 2029-11-20
US Patent Number : 7951797
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 204569
Patent Use Code : U-620
Delist Requested :
Patent Use Description : TREATMENT OF INSOMNIA
Patent Expiration Date : 2029-11-20

Patent Expiration Date : 2033-05-29
US Patent Number : 10098892
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 204569
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-05-29

Patent Expiration Date : 2029-11-20
US Patent Number : 7951797
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 204569
Patent Use Code : U-620
Delist Requested :
Patent Use Description : TREATMENT OF INSOMNIA
Patent Expiration Date : 2029-11-20

Patent Expiration Date : 2033-05-29
US Patent Number : 10098892
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 204569
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-05-29

Patent Expiration Date : 2033-05-29
US Patent Number : 11980623
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 204569
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-05-29

Patent Expiration Date : 2033-05-29
US Patent Number : 10098892
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 204569
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-05-29

Patent Expiration Date : 2033-05-29
US Patent Number : 11980623
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 204569
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-05-29

Patent Expiration Date : 2033-05-29
US Patent Number : 11980623
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 204569
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-05-29

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass also assists you with knowing the Suvorexant API Price utilized in the formulation of products. Suvorexant API Price is not always fixed or binding as the Suvorexant Price is obtained through a variety of data sources. The Suvorexant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Suvorexant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Suvorexant, including repackagers and relabelers. The FDA regulates Suvorexant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Suvorexant 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 Suvorexant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Suvorexant supplier is an individual or a company that provides Suvorexant active pharmaceutical ingredient (API) or Suvorexant finished formulations upon request. The Suvorexant suppliers may include Suvorexant API manufacturers, exporters, distributors and traders.
click here to find a list of Suvorexant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Suvorexant DMF (Drug Master File) is a document detailing the whole manufacturing process of Suvorexant active pharmaceutical ingredient (API) in detail. Different forms of Suvorexant DMFs exist exist since differing nations have different regulations, such as Suvorexant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Suvorexant DMF submitted to regulatory agencies in the US is known as a USDMF. Suvorexant USDMF includes data on Suvorexant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Suvorexant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Suvorexant suppliers with USDMF 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 Suvorexant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Suvorexant 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 Suvorexant 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 Suvorexant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Suvorexant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Suvorexant suppliers with NDC on PharmaCompass.
Suvorexant 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 Suvorexant 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 Suvorexant GMP manufacturer or Suvorexant GMP API supplier for your needs.
A Suvorexant CoA (Certificate of Analysis) is a formal document that attests to Suvorexant's compliance with Suvorexant specifications and serves as a tool for batch-level quality control.
Suvorexant CoA mostly includes findings from lab analyses of a specific batch. For each Suvorexant 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.
Suvorexant may be tested according to a variety of international standards, such as European Pharmacopoeia (Suvorexant EP), Suvorexant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Suvorexant USP).