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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 SUPPLIERS

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Metrochem API Private Limited

India

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Minakem

France

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Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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Biophore India Pharmaceuticals Pvt...

India

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Aurobindo Pharma Limited

India

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Aurobindo Pharma Limited

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Optimus Pharma

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Hangzhou APIChem Technology

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MSN Laboratories

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MSN Laboratories

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Medichem S.A

Spain

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Allastir

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Allastir

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Lee Pharma

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NDC API

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CENOBAMATE

NDC Package Code : 42765-071

Start Marketing Date : 2024-10-28

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (15kg/15kg)

Marketing Category : BULK INGREDIENT

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CENOBAMATE

NDC Package Code : 73435-036

Start Marketing Date : 2023-12-20

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (60kg/60kg)

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CENOBAMATE

NDC Package Code : 59651-881

Start Marketing Date : 2023-11-02

End Marketing Date : 2025-12-31

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CENOBAMATE

NDC Package Code : 81666-005

Start Marketing Date : 2023-09-19

End Marketing Date : 2025-12-31

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CENOBAMATE

NDC Package Code : 60240-0272

Start Marketing Date : 2024-10-18

End Marketing Date : 2025-12-31

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SK BIOTEK

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SK BIOTEK

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CENOBAMATE

NDC Package Code : 74436-0223

Start Marketing Date : 2020-03-12

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

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Listed Suppliers

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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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Cenobamate

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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Minakem

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Cenobamate

About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...

MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported by strong analytical and regulatory affairs services. The R&D team has an expertise in process development, organic synthesis, and works under a secrecy agreement to protect your IP. With 3 production sites in Europe and 1 in Canada, Minakem is ready to support your strategic sourcing projects or your reshoring activities. Recently launched commercial generic API: Apixaban, Mirabegron, Fulvestrant, remifentanil, esmolol,
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Allastir

India
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Cenobamate

About the Company : Allastir instituted the services in 2010 with a motive to cater the pharmaceutical industry with niche API's. In Allastir we strongly believe in team work and customer satisfaction...

Allastir instituted the services in 2010 with a motive to cater the pharmaceutical industry with niche API's. In Allastir we strongly believe in team work and customer satisfaction. Allastir is backed by the strong R&D team who are passionate about what they do. We manufacture niche API's with high quality which are suitable for formulations like tablets, capsules, soft gelatins and oral liquids.To be the larder to develop innovative niche molecule to the health care industry for the betterment of human life.Our Vision is to be the Number ONE company in Health care Industry in the World.
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Cenobamate

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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Lee Pharma

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Cenobamate

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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Cenobamate

About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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Medichem S.A

Spain
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Medichem S.A

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Cenobamate

About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...

Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.
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Cenobamate

About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products...

Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
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Cenobamate

About the Company : Established in 1984, R L Fine Chem Pvt. Ltd. is one of the fastest growing API companies, with a leadership position in several APIs such as antihistamines, antidepressants and mus...

Established in 1984, R L Fine Chem Pvt. Ltd. is one of the fastest growing API companies, with a leadership position in several APIs such as antihistamines, antidepressants and muscle relaxants. Acquired by private equity groups in 2016, it is one of India’s leading manufacturers of psychotropic substances. It supplies over 60 APIs to customers in more than 62 countries from FDA and EU-approved locations. R L Fine Chem is a technology-driven company with a focus on the in-house manufacture of key intermediates for our APIs. The company currently operates out of four facilities in the Indian states of Karnataka and Andhra Pradesh.
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Cenobamate

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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API Reference Price

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IHS","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES, BA","customer":"UNDISCLOSED","customerCountry":"ARGENTINA","quantity":"190.00","actualQuantity":"190","unit":"KGS","unitRateFc":"1850","totalValueFC":"345582.5","currency":"USD","unitRateINR":152832.12631578947,"date":"15-Oct-2024","totalValueINR":"29038104","totalValueInUsd":"345582.5","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"4838393","productDescription":"API","marketType":"","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730485800,"product":"CENOBAMATE(ACN)","address":"Sy.No.539\/LU,542\/A\/AA\/U\/UU,","city":"NALGONDA","supplier":"APICHEM LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"GULF AGENCY CO DUBAI","customerCountry":"UNITED ARAB EMIRATES","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"3960","totalValueFC":"7737.4","currency":"USD","unitRateINR":326474.5,"date":"02-Nov-2024","totalValueINR":"652949","totalValueInUsd":"7737.4","indian_port":"Hyderabad Air","hs_no":"29379090","bill_no":"5326980","productDescription":"API","marketType":"","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Sy.No.539\/LU,542\/A\/AA\/U\/UU,, NALGONDA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"PHARMACEUTICAL RAW MATERIAL CENOBAMATE IH (DB06119) (GST NO.37AADCM2691M1Z0 TAX INVOICE NO DD\/24-25\/1359)","address":"277\/2,BHAVESHWAR VILLA,RD.NO.31,","city":"MUMBAI,MAHARASHTRA","supplier":"SANJAY CHEMICALS","supplierCountry":"INDIA","foreign_port":"NAIROBI","customer":"UNDISCLOSED","customerCountry":"KENYA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"3350","totalValueFC":"3312.8","currency":"USD","unitRateINR":279557.46000000002,"date":"12-Nov-2024","totalValueINR":"279557.46","totalValueInUsd":"3312.8","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"5538313","productDescription":"API","marketType":"","country":"KENYA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"277\/2,BHAVESHWAR VILLA,RD.NO.31,, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738002600,"product":"CENOBAMATE PHARMACEUTICAL RAW MATERIALS","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"ACHE LABORATORIOS FARMACEUTICOS S A","customerCountry":"BRAZIL","quantity":"56.00","actualQuantity":"56","unit":"KGS","unitRateFc":"3000","totalValueFC":"165687","currency":"USD","unitRateINR":255125.95500000002,"date":"28-Jan-2025","totalValueINR":"14287053.48","totalValueInUsd":"165687","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"7657479","productDescription":"API","marketType":"","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745951400,"product":"PHARMACEUTICAL API:- CENOBAMATE","address":"5\/502, GARDEN ESTATE,","city":"THANE, MAHARASHTRA.","supplier":"AMTEC HEALTH CARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"HONG KONG","customer":"SANAGU LTD","customerCountry":"HONG KONG","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"7003","totalValueFC":"7370.4","currency":"EURO","unitRateINR":630916.65000000002,"date":"30-Apr-2025","totalValueINR":"630916.65","totalValueInUsd":"7370.4","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"1418707","productDescription":"API","marketType":"","country":"HONG KONG","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"5\/502, GARDEN ESTATE,, THANE, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746210600,"product":"CENOBAMATE(ACN)","address":"Sy.No.539\/LU,542\/A\/AA\/U\/UU,","city":"NALGONDA","supplier":"APICHEM LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"AIRPHARM PRATTELN","customerCountry":"SWITZERLAND","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"3960","totalValueFC":"3819.6","currency":"USD","unitRateINR":325435,"date":"03-May-2025","totalValueINR":"325435","totalValueInUsd":"3819.6","indian_port":"Hyderabad Air","hs_no":"29379090","bill_no":"1507408","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Sy.No.539\/LU,542\/A\/AA\/U\/UU,, NALGONDA","customerAddress":""}]
04-Aug-2023
03-May-2025
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Drugs in Development

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Details:

Bajaj is working on a generic version of the anti-seizure medication, cenobamate, as part of its efforts to expand its portfolio in the epilepsy treatment market.


Lead Product(s): Cenobamate

Therapeutic Area: Neurology Brand Name: Cenobamate-Generic

Study Phase: Phase IIProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 20, 2025

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01

Pharmex
Not Confirmed
Pharmex
Not Confirmed

Details : Bajaj is working on a generic version of the anti-seizure medication, cenobamate, as part of its efforts to expand its portfolio in the epilepsy treatment market.

Product Name : Cenobamate-Generic

Product Type : Controlled Substance

Upfront Cash : Inapplicable

March 20, 2025

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Details:

Xcopri (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.


Lead Product(s): Cenobamate

Therapeutic Area: Neurology Brand Name: Xcopri

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: SK Biopharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 20, 2025

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02

Dong-A ST Co., Ltd.

South Korea
arrow
Pharmex
Not Confirmed

Dong-A ST Co., Ltd.

South Korea
arrow
Pharmex
Not Confirmed

Details : Xcopri (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.

Product Name : Xcopri

Product Type : Controlled Substance

Upfront Cash : Inapplicable

February 20, 2025

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Details:

Xcopri (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.


Lead Product(s): Cenobamate

Therapeutic Area: Neurology Brand Name: Xcopri

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: SK Biopharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 10, 2024

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03

Pharmex
Not Confirmed
Pharmex
Not Confirmed

Details : Xcopri (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.

Product Name : Xcopri

Product Type : Controlled Substance

Upfront Cash : Inapplicable

December 10, 2024

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Details:

Ignis Therapeutics holds exclusive commercialization rights to Xcopri (cenobamate), is an antiseizure medication for epilepsy in Greater China.


Lead Product(s): Cenobamate

Therapeutic Area: Neurology Brand Name: Xcopri

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: SK Biopharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 04, 2024

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04

Pharmex
Not Confirmed
Pharmex
Not Confirmed

Details : Ignis Therapeutics holds exclusive commercialization rights to Xcopri (cenobamate), is an antiseizure medication for epilepsy in Greater China.

Product Name : Xcopri

Product Type : Controlled Substance

Upfront Cash : Inapplicable

December 04, 2024

blank

Details:

Xcopri (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.


Lead Product(s): Cenobamate

Therapeutic Area: Neurology Brand Name: Xcopri

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 04, 2024

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05

SK Biopharmaceuticals

South Korea
arrow
Pharmex
Not Confirmed

SK Biopharmaceuticals

South Korea
arrow
Pharmex
Not Confirmed

Details : Xcopri (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.

Product Name : Xcopri

Product Type : Controlled Substance

Upfront Cash : Inapplicable

November 04, 2024

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Details:

Xcopri (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.


Lead Product(s): Cenobamate

Therapeutic Area: Neurology Brand Name: Xcopri

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: SK Biopharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 08, 2024

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06

Eurofarma

Brazil
arrow
Pharmex
Not Confirmed

Eurofarma

Brazil
arrow
Pharmex
Not Confirmed

Details : Xcopri (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.

Product Name : Xcopri

Product Type : Controlled Substance

Upfront Cash : Inapplicable

October 08, 2024

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Details:

Xcopri (cenobamate) is a positive allosteric modulator of the GABAA ion channel. It is approved as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.


Lead Product(s): Cenobamate

Therapeutic Area: Neurology Brand Name: Xcopri

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 22, 2024

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07

Pharmex
Not Confirmed
Pharmex
Not Confirmed

Details : Xcopri (cenobamate) is a positive allosteric modulator of the GABAA ion channel. It is approved as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.

Product Name : Xcopri

Product Type : Controlled Substance

Upfront Cash : Inapplicable

January 22, 2024

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Details:

Under the terms of the agreement, Hikma will have priority rights for the commercialisation and manufacture of SK Biopharmaceuticals’ current and future pipeline of innovative products for 17 countries in the MENA region.


Lead Product(s): Cenobamate

Therapeutic Area: Neurology Brand Name: Xcopri

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Hikma Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement August 21, 2023

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08

SK Biopharmaceuticals

South Korea
arrow
Pharmex
Not Confirmed

SK Biopharmaceuticals

South Korea
arrow
Pharmex
Not Confirmed

Details : Under the terms of the agreement, Hikma will have priority rights for the commercialisation and manufacture of SK Biopharmaceuticals’ current and future pipeline of innovative products for 17 countries in the MENA region.

Product Name : Xcopri

Product Type : Controlled Substance

Upfront Cash : Undisclosed

August 21, 2023

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Details:

XCOPRI™ (cenobamate tablets) inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel, which is used for partial-onset seizures in adults with epilepsy.


Lead Product(s): Cenobamate

Therapeutic Area: Neurology Brand Name: Xcopri

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 29, 2023

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09

Pharmex
Not Confirmed
Pharmex
Not Confirmed

Details : XCOPRI™ (cenobamate tablets) inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel, which is used for partial-onset seizures in adults with epilepsy.

Product Name : Xcopri

Product Type : Controlled Substance

Upfront Cash : Inapplicable

June 29, 2023

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Details:

Ontozry (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.


Lead Product(s): Cenobamate

Therapeutic Area: Neurology Brand Name: Ontozry

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: SK Biopharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 16, 2023

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10

Pharmex
Not Confirmed
Pharmex
Not Confirmed

Details : Ontozry (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.

Product Name : Ontozry

Product Type : Controlled Substance

Upfront Cash : Inapplicable

May 16, 2023

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ABOUT THIS PAGE

Looking for 913088-80-9 / Cenobamate API manufacturers, exporters & distributors?

Cenobamate manufacturers, exporters & distributors 1

89

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

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

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

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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