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Also known as: 1030377-33-3, Mk-4305, Belsomra, Mk4305, Mk 4305, [(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
Molecular Formula
C23H23ClN6O2
Molecular Weight
450.9  g/mol
InChI Key
JYTNQNCOQXFQPK-MRXNPFEDSA-N
FDA UNII
081L192FO9

Suvorexant
Suvorexant is a selective dual antagonist of orexin receptors OX1R and OX2R that promotes sleep by reducing wakefulness and arousal. It has been approved for the treatment of insomnia.
Suvorexant is an Orexin Receptor Antagonist. The mechanism of action of suvorexant is as an Orexin Receptor Antagonist, and P-Glycoprotein Inhibitor, and Cytochrome P450 3A Inhibitor.
1 2D Structure

Suvorexant

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl]-[5-methyl-2-(triazol-2-yl)phenyl]methanone
2.1.2 InChI
InChI=1S/C23H23ClN6O2/c1-15-3-5-20(30-25-8-9-26-30)18(13-15)22(31)29-12-11-28(10-7-16(29)2)23-27-19-14-17(24)4-6-21(19)32-23/h3-6,8-9,13-14,16H,7,10-12H2,1-2H3/t16-/m1/s1
2.1.3 InChI Key
JYTNQNCOQXFQPK-MRXNPFEDSA-N
2.1.4 Canonical SMILES
CC1CCN(CCN1C(=O)C2=C(C=CC(=C2)C)N3N=CC=N3)C4=NC5=C(O4)C=CC(=C5)Cl
2.1.5 Isomeric SMILES
C[C@@H]1CCN(CCN1C(=O)C2=C(C=CC(=C2)C)N3N=CC=N3)C4=NC5=C(O4)C=CC(=C5)Cl
2.2 Other Identifiers
2.2.1 UNII
081L192FO9
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2008-10-20
3 Chemical and Physical Properties
Molecular Weight 450.9 g/mol
Molecular Formula C23H23ClN6O2
XLogP34.9
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count6
Rotatable Bond Count3
Exact Mass450.1571017 g/mol
Monoisotopic Mass450.1571017 g/mol
Topological Polar Surface Area80.3 Ų
Heavy Atom Count32
Formal Charge0
Complexity664
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Suvorexant is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.


FDA Label


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
SUVOREXANT
5.2.2 FDA UNII
081L192FO9
5.2.3 Pharmacological Classes
Orexin Receptor Antagonist [EPC]; Orexin Receptor Antagonists [MoA]; P-Glycoprotein Inhibitors [MoA]; Cytochrome P450 3A Inhibitors [MoA]
5.3 ATC Code

N - Nervous system

N05 - Psycholeptics

N05C - Hypnotics and sedatives

N05CM - Other hypnotics and sedatives

N05CM19 - Suvorexant


5.4 Absorption, Distribution and Excretion

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.


5.5 Metabolism/Metabolites

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.


5.6 Biological Half-Life

Mean half life is approximately 12 hours.


5.7 Mechanism of Action

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.


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01

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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Suvorexant

About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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02

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Suvorexant

About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...

Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.
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03

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Suvorexant

About the Company : Bajaj Healthcare Ltd. is a company established in 1993, services various Pharmaceuticals, Nutraceutical and Food industries globally with a spirit of scrupulousness. Bajaj Healt...

Bajaj Healthcare Ltd. is a company established in 1993, services various Pharmaceuticals, Nutraceutical and Food industries globally with a spirit of scrupulousness. Bajaj Healthcare Ltd. have metamorphosed into specialty company and focused on development, manufacturing and supply of Amino Acids, Nutritional Supplements and Active Pharmaceutical Ingredients (API) for Pharmaceutical, Nutraceuticals and Food industries. Bajaj healthcare Ltd. in its shot life span has gained loyalty from national and international customers and our products enjoy good fame in the overseas market.
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DEAFARMA

Italy
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DEAFARMA

Italy
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Suvorexant

About the Company : In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territo...

In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territory. DEAFARMA works with success in the pharmaceutical raw materials field through Agencies and professional relations with the most important European and Asiatic factories. Our partners are well known, reliable producers and all of them are operating in accordance with the latest GMP Rules. The APIs mentioned in the DEAFARMA catalogue are always supported by DMF and/or CEP.
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Suvorexant

About the Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, cat...

Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, catering to both export and import markets. The company consists of two primary business departments: the Professional Sourcing/Product Team and the Quality Team. Backed by experienced partners, Longshine has evolved into a trustworthy supplier of high-quality products and received ISO9001:2008 certification in 2017.
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Hetero Drugs

India
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Hetero Drugs

India
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Suvorexant

About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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Lee Pharma

India
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Lee Pharma

India
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Suvorexant

About the Company : Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affor...

Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affordable and high-quality healthcare solutions. Through advanced research, modern manufacturing, and a strong emphasis on quality, we are dedicated to producing medicines that enhance lives. Lee Pharma is a research-focused company that prioritizes the development, synthesis, and commercialization of high-quality Active Pharmaceutical Ingredients (APIs), intermediate chemicals, and finished formulations.
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Suvorexant

About the Company : We believe in attaining the highest levels of customer satisfaction and social welfare with the philosophy of keeping first things first. Our systematic interventions keeping abrea...

We believe in attaining the highest levels of customer satisfaction and social welfare with the philosophy of keeping first things first. Our systematic interventions keeping abreast of new and emerging technologies consistently help us meet and exceed quality standards with significant innovations. At LifeFirst, we strive to maintain our goodwill as one of the key partners of choice with the reputation of delivering consistently high-quality products to the pharmaceutical industry. After all, our fundamental philosophy is to offer unrelenting care and cure worldwide with our innovations.
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Suvorexant

About the Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide range of therapeutic cat...

Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide range of therapeutic categories specifically focusing on Anti-Fungal and Anti-Platelets. Our vision is to attain market leadership in development of innovator molecules for the domestic and export market.
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Suvorexant

About the Company : SMS Pharmaceuticals Ltd. is a global player in API manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a sin...

SMS Pharmaceuticals Ltd. is a global player in API manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a single facility - single product manufacturing company in 1990 grew to be a multi-location group having product list spreading across an array of therapeutic segments. SMS was given the export house status in the year 1997-98. SMS is currently a listed company having ever appreciating international and domestic customer base.
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LIMITED","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"N\/A","customerCountry":"TAIWAN","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"43000","totalValueFC":"4255.5","currency":"USD","unitRateINR":3700.7800000000002,"date":"12-Feb-2025","totalValueINR":"370078","totalValueInUsd":"4255.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"8090298","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-166\/182, A BLOCK, NORTH WING,,, ERRADADDA,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"SUVOREXANT (FORM-II) (FREE SAMPLES)","address":"8-3-166\/182, A BLOCK, NORTH WING,,","city":"ERRADADDA,TELANGANA","supplier":"DASAMI LAB PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"TOKYO","customer":"CBC CO LTD","customerCountry":"JAPAN","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"10000","totalValueFC":"438.1","currency":"USD","unitRateINR":759000,"date":"29-Mar-2025","totalValueINR":"37950","totalValueInUsd":"438.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"9494871","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-166\/182, A BLOCK, NORTH WING,,, ERRADADDA,TELANGANA","customerAddress":""}]
20-Oct-2022
29-Mar-2025
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ABOUT THIS PAGE

Looking for 1030377-33-3 / Suvorexant API manufacturers, exporters & distributors?

Suvorexant manufacturers, exporters & distributors 1

23

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

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

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.

API | Excipient name

Suvorexant

Synonyms

1030377-33-3, Mk-4305, Belsomra, Mk4305, Mk 4305, [(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

Cas Number

1030377-33-3

Unique Ingredient Identifier (UNII)

081L192FO9

About Suvorexant

Suvorexant is a selective dual antagonist of orexin receptors OX1R and OX2R that promotes sleep by reducing wakefulness and arousal. It has been approved for the treatment of insomnia.

Suvorexant Manufacturers

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.

Suvorexant Suppliers

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.

Suvorexant USDMF

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.

Suvorexant 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 Suvorexant as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Suvorexant 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 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.

Compounded drug products

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 GMP

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.

Suvorexant CoA

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).

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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