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CEP/COS Certifications

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Chemistry

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Also known as: Arketamine, D-ketamine, (r)-(+)-ketamine, (+)-ketamine, 33643-49-1, Ketamine, r-
Molecular Formula
C13H16ClNO
Molecular Weight
237.72  g/mol
InChI Key
YQEZLKZALYSWHR-CYBMUJFWSA-N
FDA UNII
Y2RI13H7VW

R-Ketamine
1 2D Structure

R-Ketamine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R)-2-(2-chlorophenyl)-2-(methylamino)cyclohexan-1-one
2.1.2 InChI
InChI=1S/C13H16ClNO/c1-15-13(9-5-4-8-12(13)16)10-6-2-3-7-11(10)14/h2-3,6-7,15H,4-5,8-9H2,1H3/t13-/m1/s1
2.1.3 InChI Key
YQEZLKZALYSWHR-CYBMUJFWSA-N
2.1.4 Canonical SMILES
CNC1(CCCCC1=O)C2=CC=CC=C2Cl
2.1.5 Isomeric SMILES
CN[C@]1(CCCCC1=O)C2=CC=CC=C2Cl
2.2 Other Identifiers
2.2.1 UNII
Y2RI13H7VW
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Arketamine

2. D-ketamine

3. (r)-(+)-ketamine

4. (+)-ketamine

5. 33643-49-1

6. Ketamine, R-

7. Ketamine, (r)-

8. Y2ri13h7vw

9. (2r)-2-(2-chlorophenyl)-2-(methylamino)cyclohexan-1-one

10. Chebi:580604

11. (2r)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone

12. Cyclohexanone, 2-(2-chlorophenyl)-2-(methylamino)-, (2r)-

13. J238.629a

14. (2r)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone

15. Cyclohexanone, 2-(o-chlorophenyl)-2-(methylamino)-, (+)-

16. (s) Ketamine

17. Unii-y2ri13h7vw

18. Arketamine [who-dd]

19. Dsstox_cid_28673

20. Dsstox_rid_82943

21. Dsstox_gsid_48747

22. Schembl16104

23. Chembl467505

24. Gtpl9153

25. Dtxsid2048747

26. Pcn-101

27. Tox21_113205

28. Zinc36294079

29. Ncgc00185909-01

30. Cas-33643-49-1

31. Hr-071603

32. Q20707684

33. (2r)-2-(2-chlorophenyl)-2-methylaminocyclohexan-1-one

34. Cyclohexanone, 2-(2-chlorophenyl)-2-(methylamino)-, (r)-

35. Cyclohexanone, 2-(2-chlorophenyl)-2-(methylamino)-, (2r)- (9ci)

36. Cyclohexanone, 2-(o-chlorophenyl)-2-(methylamino)-, (+)- (8ci)

37. Rke

2.4 Create Date
2005-06-08
3 Chemical and Physical Properties
Molecular Weight 237.72 g/mol
Molecular Formula C13H16ClNO
XLogP32.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count2
Rotatable Bond Count2
Exact Mass237.0920418 g/mol
Monoisotopic Mass237.0920418 g/mol
Topological Polar Surface Area29.1 Ų
Heavy Atom Count16
Formal Charge0
Complexity269
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 Metabolism/Metabolites

(r)-ketamine has known human metabolites that include Norketamine.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


API SUPPLIERS

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01

Seqens

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Drugs in Development

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Details:

PCN-101 (R-ketamine), a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects.


Lead Product(s): R-Ketamine,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Controlled Substance

Sponsor: ATAI Life Sciences

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 08, 2023

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01

The MedTech Conference
Not Confirmed
The MedTech Conference
Not Confirmed

Details : PCN-101 (R-ketamine), a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-...

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

August 08, 2023

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Details:

PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive NMDA receptor antagonist.


Lead Product(s): R-Ketamine,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 13, 2023

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02

The MedTech Conference
Not Confirmed
The MedTech Conference
Not Confirmed

Details : PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive NMDA receptor a...

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

April 13, 2023

blank

Details:

PCN-101 (R-ketamine), demonstrated an encouraging safety profile and signals of efficacy across all timepoints despite not achieving statistical significance on the primary endpoint.


Lead Product(s): R-Ketamine,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Controlled Substance

Sponsor: Otsuka Pharmaceutical

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 06, 2023

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03

The MedTech Conference
Not Confirmed
The MedTech Conference
Not Confirmed

Details : PCN-101 (R-ketamine), demonstrated an encouraging safety profile and signals of efficacy across all timepoints despite not achieving statistical significance on the primary endpoint.

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

January 06, 2023

blank

Details:

PCN-101 (R-ketamine) is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant (RAAD) activity and anti-suicidal effects.


Lead Product(s): R-Ketamine,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 17, 2022

blank

04

The MedTech Conference
Not Confirmed
The MedTech Conference
Not Confirmed

Details : PCN-101 (R-ketamine) is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant (RAAD) activity and anti-suicidal effects.

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

November 17, 2022

blank

Details:

PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive NMDA receptor antagonist.


Lead Product(s): R-Ketamine,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 25, 2022

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05

The MedTech Conference
Not Confirmed
The MedTech Conference
Not Confirmed

Details : PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive NMDA rec...

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

October 25, 2022

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Details:

PCN-101 is a Controlled Substance drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Depressive Disorder, Treatment-Resistant.


Lead Product(s): R-Ketamine,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Controlled Substance

Sponsor: Precision For Medicine | IQVIA

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 10, 2022

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06

The MedTech Conference
Not Confirmed
The MedTech Conference
Not Confirmed

Lead Product(s) : R-Ketamine,Inapplicable

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Precision For Medicine | IQVIA

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : PCN-101 is a Controlled Substance drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Depressive Disorder, Treatment-Resistant.

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

June 10, 2022

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Details:

In the aggregate, these renewed lock-up agreements represent over 30% of atai’s outstanding common shares and illustrate the confidence of atai’s key shareholders in atai’s platform and its potential to address the growing mental health crisis including its lead asset PCN-101.


Lead Product(s): R-Ketamine,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Controlled Substance

Sponsor: Apeiron Investment Group

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 15, 2021

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07

The MedTech Conference
Not Confirmed
The MedTech Conference
Not Confirmed

Details : In the aggregate, these renewed lock-up agreements represent over 30% of atai’s outstanding common shares and illustrate the confidence of atai’s key shareholders in atai’s platform and its potential to address the growing mental health crisis incl...

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Undisclosed

December 15, 2021

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Details:

Company initiate, Phase 2a clinical study to evaluate the safety and efficacy of PCN-101 (R-ketamine), a stereoisomer of ketamine being developed for therapeutic treatment of psychiatric disorders such as TRD.


Lead Product(s): R-Ketamine,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Controlled Substance

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 14, 2021

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08

The MedTech Conference
Not Confirmed
The MedTech Conference
Not Confirmed

Details : Company initiate, Phase 2a clinical study to evaluate the safety and efficacy of PCN-101 (R-ketamine), a stereoisomer of ketamine being developed for therapeutic treatment of psychiatric disorders such as TRD.

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

September 14, 2021

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Details:

Integration of Introspect’s digital therapeutic with R-ketamine therapy for patients with treatment resistant depression.


Lead Product(s): R-Ketamine,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Controlled Substance

Sponsor: ATAI Life Sciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration September 09, 2021

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09

The MedTech Conference
Not Confirmed
The MedTech Conference
Not Confirmed

Details : Integration of Introspect’s digital therapeutic with R-ketamine therapy for patients with treatment resistant depression.

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Undisclosed

September 09, 2021

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Details:

Under the terms of the license, Otsuka will have exclusive rights to develop and commercialize products containing PCN-101 in Japan. Otsuka will undertake development, regulatory, and commercialization activities in Japan, with input and guidance from both companies.


Lead Product(s): R-Ketamine,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Controlled Substance

Sponsor: Otsuka Pharmaceutical

Deal Size: Undisclosed Upfront Cash: $20.0 million

Deal Type: Collaboration March 16, 2021

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10

The MedTech Conference
Not Confirmed
The MedTech Conference
Not Confirmed

Details : Under the terms of the license, Otsuka will have exclusive rights to develop and commercialize products containing PCN-101 in Japan. Otsuka will undertake development, regulatory, and commercialization activities in Japan, with input and guidance from bo...

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : $20.0 million

March 16, 2021

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Looking for 33643-49-1 / R-Ketamine API manufacturers, exporters & distributors?

R-Ketamine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of R-Ketamine 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 R-Ketamine manufacturer or R-Ketamine supplier for your needs.

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

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

API | Excipient name

R-Ketamine

Synonyms

Arketamine, D-ketamine, (r)-(+)-ketamine, (+)-ketamine, 33643-49-1, Ketamine, r-

Cas Number

33643-49-1

Unique Ingredient Identifier (UNII)

Y2RI13H7VW

R-Ketamine Manufacturers

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

R-Ketamine Suppliers

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

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

R-Ketamine GMP

R-Ketamine 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 R-Ketamine 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 R-Ketamine GMP manufacturer or R-Ketamine GMP API supplier for your needs.

R-Ketamine CoA

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

R-Ketamine CoA mostly includes findings from lab analyses of a specific batch. For each R-Ketamine 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.

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