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Chemistry

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Also known as: Xcopri, 913088-80-9, Cenobamate [inn], Ykp3089, Ykp-3089, P85x70rzws
Molecular Formula
C10H10ClN5O2
Molecular Weight
267.67  g/mol
InChI Key
GFHAXPJGXSQLPT-VIFPVBQESA-N
FDA UNII
P85X70RZWS

Cenobamate
Cenobamate, or YKP-3089, is an antiepileptic drug developed by SK Pharmaceuticals and used to treat partial onset seizures. The exact mechanism of action has not been described in the literature, though it positively modulates GABAA and inhibits voltage gated sodium channels. Cenobamate was granted FDA approval on 21 November 2019.
1 2D Structure

Cenobamate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-yl)ethyl] carbamate
2.1.2 InChI
InChI=1S/C10H10ClN5O2/c11-8-4-2-1-3-7(8)9(18-10(12)17)5-16-14-6-13-15-16/h1-4,6,9H,5H2,(H2,12,17)/t9-/m0/s1
2.1.3 InChI Key
GFHAXPJGXSQLPT-VIFPVBQESA-N
2.1.4 Canonical SMILES
C1=CC=C(C(=C1)C(CN2N=CN=N2)OC(=O)N)Cl
2.1.5 Isomeric SMILES
C1=CC=C(C(=C1)[C@H](CN2N=CN=N2)OC(=O)N)Cl
2.2 Other Identifiers
2.2.1 UNII
P85X70RZWS
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2h-tetrazole-2-ethanol, Alpha-(2-chlorophenyl)-, Carbamate (ester), (alphar)-

2. Carbamic Acid (r)-(+)-1-(2-chlorophenyl)-2-(2h-tetrazol-2-yl)ethyl Ester

3. Xcopri

4. Ykp-3089

5. Ykp3089

2.3.2 Depositor-Supplied Synonyms

1. Xcopri

2. 913088-80-9

3. Cenobamate [inn]

4. Ykp3089

5. Ykp-3089

6. P85x70rzws

7. [(1r)-1-(2-chlorophenyl)-2-(tetrazol-2-yl)ethyl] Carbamate

8. Carbamic Acid (r)-(+)-1-(2-chlorophenyl)-2-(2h-tetrazol-2-yl)ethyl Ester

9. Ontozry

10. Unii-p85x70rzws

11. Xcopri (tn)

12. Cenobamate [mi]

13. Ykp-3089 Cenobamate

14. Cenobamate (usan/inn)

15. Cenobamate [usan:inn]

16. Cenobamate [usan]

17. Cenobamate [who-dd]

18. Schembl1682643

19. Cenobamate [orange Book]

20. Chembl3989949

21. Gtpl10773

22. Ykp3089ykp3089

23. Dtxsid001027948

24. Ex-a3604

25. 2h-tetrazole-2-ethanol, Alpha-(2-chlorophenyl)-, 2-carbamate, (alphar)-

26. Db06119

27. 2h-tetrazole-2-ethanol, Alpha-(2-chlorophenyl)-, Carbamate (ester), (alphar)-

28. Hy-17607

29. Cs-0014686

30. D11150

31. Q27286352

32. (1r)-1-(2-chlorophenyl)-2-(tetrazol-yl)ethyl)carbamate

33. (1r)-1-(2-chlorophenyl)-2-(2h-1,2,3,4-tetrazol-2-yl)ethyl Carbamate

34. (1r)-1-(2-chlorophenyl)-2-(2h-tetrazol-2-yl)ethyl Carbamate

35. 2h-tetrazole-2-ethanol, .alpha.-(2-chlorophenyl)-, 2-carbamate, (.alpha.r)-

36. 2h-tetrazole-2-ethanol, .alpha.-(2-chlorophenyl)-, Carbamate (ester), (.alpha.r)-

37. 2h-tetrazole-2-ethanol, Alpha-(2-chlorophenyl)-, Yl)ethyl)carbamate Carbamate (ester), (.alpha.r)-

2.4 Create Date
2006-12-11
3 Chemical and Physical Properties
Molecular Weight 267.67 g/mol
Molecular Formula C10H10ClN5O2
XLogP31.5
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count5
Exact Mass267.0523023 g/mol
Monoisotopic Mass267.0523023 g/mol
Topological Polar Surface Area95.9 Ų
Heavy Atom Count18
Formal Charge0
Complexity293
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

Cenobamate is indicated for the treatment of partial onset seizures in adults.


Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.


5 Pharmacology and Biochemistry
5.1 Pharmacology

The mechanism of cenobamate is unknown, however it modulates GABAA and inhibit voltage gated sodium channels. Cenobamate is given once daily and so it has a long duration of action. The therapeutic window is wide as doses of 750mg can be well tolerated. Patients should be counselled regarding the risk of DRESS syndrome, QT interval shortening, suicidal behavior, and neurological adverse effects.


5.2 MeSH Pharmacological Classification

Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)


5.3 ATC Code

N03AX


N - Nervous system

N03 - Antiepileptics

N03A - Antiepileptics

N03AX - Other antiepileptics

N03AX25 - Cenobamate


5.4 Absorption, Distribution and Excretion

Absorption

Cenobamate is 88% orally bioavailable with a Tmax of 1-4 hours. A high fat meal does not significantly impact the pharmacokinetics of cenobamate.


Route of Elimination

Cenobamate is 87.8% eliminated in the urine and 5.2% in the feces.


Volume of Distribution

The apparent volume of distribution of cenobamate is 40-50L.


Clearance

The apparent oral clearance of cenobamate is 0.45-0.63L/h for a 100-400mg/day dose.


5.5 Metabolism/Metabolites

Data regarding the metabolism of cenobamate is lacking, however it is mostly glucuronidated by UGT2B7 and UGT2B4 or oxidized by a number of cytochromes.


5.6 Biological Half-Life

The terminal half life of cenobamate is 50-60h.


5.7 Mechanism of Action

Cenobamate inhibits voltage gated sodium channels and is a positive GABAA modulator. However, the exact mechanism of action remains unknown. Inhibition of voltage gated sodium channels increases the threshold for generating action potentials and decreases the number of action potentials.


API Reference Price

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21-Feb-2024
15-Oct-2024
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Company :

Cenobamate

Drug Cost (USD) : 68,154,842

Year : 2022

Prescribers : 6411

Prescriptions : 53354

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Company :

Cenobamate

Drug Cost (USD) : 32,547,978

Year : 2021

Prescribers : 4124

Prescriptions : 28039

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Finished Drug Prices

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Cenobamate

Dosage Form : Filmtabl

Dosage Strength : 100mg

Price Per Pack (Euro) : 50.63

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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U.S.A
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Brand Name : Ontozry

U.S.A
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Cenobamate

Dosage Form : Filmtabl

Dosage Strength : 100mg

Price Per Pack (Euro) : 101.26

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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Brand Name : Ontozry

U.S.A
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Brand Name : Ontozry

U.S.A
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Cenobamate

Dosage Form : Filmtabl

Dosage Strength : 150mg

Price Per Pack (Euro) : 50.63

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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Brand Name : Ontozry

U.S.A
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Brand Name : Ontozry

U.S.A
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Cenobamate

Dosage Form : Filmtabl

Dosage Strength : 150mg

Price Per Pack (Euro) : 101.26

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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05

Brand Name : Ontozry

U.S.A
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Brand Name : Ontozry

U.S.A
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Cenobamate

Dosage Form : Filmtabl

Dosage Strength : 200mg

Price Per Pack (Euro) : 50.63

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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Brand Name : Ontozry

U.S.A
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Brand Name : Ontozry

U.S.A
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Cenobamate

Dosage Form : Filmtabl

Dosage Strength : 200mg

Price Per Pack (Euro) : 101.26

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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07

Brand Name : Ontozry

U.S.A
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Brand Name : Ontozry

U.S.A
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Cenobamate

Dosage Form : Filmtabl

Dosage Strength : 50mg

Price Per Pack (Euro) : 50.63

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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Brand Name : Ontozry

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Brand Name : Ontozry

U.S.A
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Cenobamate

Dosage Form : Filmtabl

Dosage Strength : 50mg

Price Per Pack (Euro) : 101.26

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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Brand Name : Ontozry Starterpackung

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Brand Name : Ontozry Starterpackung

U.S.A
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Cenobamate

Dosage Form : Filmtabl

Dosage Strength : 12.5mg and 25mg

Price Per Pack (Euro) : 101.26

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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Brand Name : Ontozory

Denmark
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Brand Name : Ontozory

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Cenobamate

Dosage Form : Tablet, film-coated

Dosage Strength : 200 mg

Price Per Pack (Euro) : 111.46

Published in :

Country : Norway

RX/OTC/DISCN :

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US Patents

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SK LIFE

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CENOBAMATE

US Patent Number : 7598279

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 212839

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-30

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SK LIFE

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CENOBAMATE

US Patent Number : 11654133

Drug Substance Claim :

Drug Product Claim :

Application Number : 212839

Patent Use Code : U-3610

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-06-16

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SK LIFE

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CENOBAMATE

US Patent Number : 7598279

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 212839

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-30

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SK LIFE

U.S.A
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CENOBAMATE

US Patent Number : 11654133

Drug Substance Claim :

Drug Product Claim :

Application Number : 212839

Patent Use Code : U-3610

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-06-16

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SK LIFE

U.S.A
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CENOBAMATE

US Patent Number : 11654133

Drug Substance Claim :

Drug Product Claim :

Application Number : 212839

Patent Use Code : U-3610

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-06-16

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SK LIFE

U.S.A
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CENOBAMATE

US Patent Number : 7598279

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 212839

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-30

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SK LIFE

U.S.A
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CENOBAMATE

US Patent Number : 11654133

Drug Substance Claim :

Drug Product Claim :

Application Number : 212839

Patent Use Code : U-3610

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-06-16

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SK LIFE

U.S.A
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CENOBAMATE

US Patent Number : 11654133

Drug Substance Claim :

Drug Product Claim :

Application Number : 212839

Patent Use Code : U-3610

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-06-16

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SK LIFE

U.S.A
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Not Confirmed

CENOBAMATE

US Patent Number : 7598279

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 212839

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-30

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10

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SK LIFE

U.S.A
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CENOBAMATE

US Patent Number : 7598279

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 212839

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-30

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US Exclusivities

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SK LIFE

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CENOBAMATE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2025-03-10

Application Number : 212839

Product Number : 3

Exclusivity Details :

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SK LIFE

U.S.A
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CENOBAMATE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2025-03-10

Application Number : 212839

Product Number : 1

Exclusivity Details :

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SK LIFE

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Exclusivity Code : NCE

Exclusivity Expiration Date : 2025-03-10

Application Number : 212839

Product Number : 4

Exclusivity Details :

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SK LIFE

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CENOBAMATE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2025-03-10

Application Number : 212839

Product Number : 2

Exclusivity Details :

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Exclusivity Code : NCE

Exclusivity Expiration Date : 2025-03-10

Application Number : 212839

Product Number : 5

Exclusivity Details :

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Exclusivity Code : NCE

Exclusivity Expiration Date : 2025-03-10

Application Number : 212839

Product Number : 6

Exclusivity Details :

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ABOUT THIS PAGE

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Cenobamate manufacturers, exporters & distributors 1

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API | Excipient name

Cenobamate

Synonyms

Xcopri, 913088-80-9, Cenobamate [inn], Ykp3089, Ykp-3089, P85x70rzws

Cas Number

913088-80-9

Unique Ingredient Identifier (UNII)

P85X70RZWS

About Cenobamate

Cenobamate, or YKP-3089, is an antiepileptic drug developed by SK Pharmaceuticals and used to treat partial onset seizures. The exact mechanism of action has not been described in the literature, though it positively modulates GABAA and inhibits voltage gated sodium channels. Cenobamate was granted FDA approval on 21 November 2019.

Cenobamate Manufacturers

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

Cenobamate Suppliers

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

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

Cenobamate USDMF

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

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

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

Cenobamate WC

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

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

Cenobamate 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 Cenobamate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Cenobamate GMP

Cenobamate 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 Cenobamate 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 Cenobamate GMP manufacturer or Cenobamate GMP API supplier for your needs.

Cenobamate CoA

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

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

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