Find Esketamine Hydrochloride manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

0

Health Canada Patents

API REF. PRICE (USD/KG)

$
$ 0
API/FDF Prices: Book a Demo to
explore the features and consider
upgrading later

MARKET PLACE

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Weekly News Recap #Phispers

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as: (s)-ketamine, L-ketamine, (-)-ketamine, S-ketamine, 33643-46-8, (s)-(-)-ketamine
Molecular Formula
C13H16ClNO
Molecular Weight
237.72  g/mol
InChI Key
YQEZLKZALYSWHR-ZDUSSCGKSA-N
FDA UNII
50LFG02TXD

Esketamine Hydrochloride
Esketamine is a cyclohexanone derivative and S-enantiomer of racemic ketamine, with analgesic, anesthetic and antidepressant activities. Although the mechanism of action is not fully understood, upon administration, esketamine targets, non-competitively binds to, and blocks N-methyl D-aspartate (NMDA) receptors. This reduces pain perception, induces sedation, and produce dissociative anesthesia.
1 2D Structure

Esketamine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-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-/m0/s1
2.1.3 InChI Key
YQEZLKZALYSWHR-ZDUSSCGKSA-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
50LFG02TXD
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (-)-ketamine

2. (s)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone

3. Kataved

4. L-ketamine

5. S-ketamine

6. Spravato

2.3.2 Depositor-Supplied Synonyms

1. (s)-ketamine

2. L-ketamine

3. (-)-ketamine

4. S-ketamine

5. 33643-46-8

6. (s)-(-)-ketamine

7. Spravato

8. S-(-)-ketamine

9. Ketaved

10. Keta-s

11. Ketamine, S-

12. Esketamine Free Base

13. Ketamine, (s)-

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

15. 50lfg02txd

16. Chebi:60799

17. Jnj-54135419

18. (+)-ketamine

19. (2s)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone

20. (2s)-2-(2-chlorophenyl)-2-(methylamino)cyclohexan-1-one

21. Cyclohexanone, 2-(2-chlorophenyl)-2-(methylamino)-, (2s)-

22. (2~{s})-2-(2-chlorophenyl)-2-(methylamino)cyclohexan-1-one

23. Cyclohexanone, 2-(2-chlorophenyl)-2-(methylamino)-, (s)-

24. Unii-50lfg02txd

25. Kataved

26. Esketamine [usan:inn:ban]

27. S-ketamin

28. Jc9

29. Esketamine [inn]

30. Esketamine (usan/inn)

31. Esketamine [usan]

32. Dsstox_cid_27787

33. Dsstox_rid_82562

34. Esketamine [who-dd]

35. Dsstox_gsid_47810

36. Chembl395091

37. Gtpl9152

38. Schembl5512024

39. Dtxsid6047810

40. 33643-46-8 (free Base)

41. Tox21_113206

42. Zinc35999642

43. Akos027321219

44. Db11823

45. Ncgc00185910-01

46. Cas-33643-46-8

47. D07283

48. Q2365493

49. (2s)-2-(2-chlorophenyl)-2-methylaminocyclohexan-1-one

50. (s)-2-(2-chlorophenyl)-2-(methylamino)cyclohexan-1-one

51. Cyclohexanone, 2-(2-chlorophenyl)-2-(methylamino)-, (2s)- (9ci)

52. Cyclohexanone, 2-(o-chlorophenyl)-2-(methylamino)-, (-)-

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

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 Drug and Medication Information
4.1 Drug Indication

This drug is indicated in conjunction with an oral antidepressant for the treatment of treatment-resistant depression (TRD) in adults. Note: Esketamine is not approved as an anesthetic agent. The safety and effectiveness of esketamine as an anesthetic agent have not been established to this date.


FDA Label


Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.


5 Pharmacology and Biochemistry
5.1 Pharmacology

**General effects** Esketamine is considered a central nervous system (CNS) depressant agent. It may cause sedation, dizziness, and lethargy, among other symptoms. This drug has dissociative and antidepressant properties. Acutely, esketamine may impair attention, judgment, thinking, reaction speed, and motor skills. Two placebo-controlled studies were performed to evaluate the effects of ketamine on the ability to drive. The effects of esketamine 84 mg were comparable to placebo at 6 hours and 18 hours post ingestion. **Effects on cardiac electrophysiology** The effect of esketamine (84 mg nasal spray and 0.8 mg/kg esketamine intravenously infused over 40 minutes) on the QTc interval was studied in a randomized, double-blind, placebo-, and positive-controlled (moxifloxacin 400 mg), 4-period, crossover study in 60 healthy volunteers. A marked increase in heart rate (higher than 10 bpm) was measured in subjects receiving intranasal and intravenous esketamine. Summative evidence from both nonclinical and clinical data suggests a lack of clinically relevant QTc prolongation at the normal therapeutic dose of esketamine. **Effects on blood pressure** Eskestamine causes increases in systolic and/or diastolic blood pressure at all therapeutic doses. Peak blood pressure elevation after esketamine administration occurs about 40 minutes after administration and lasts approximately 4 hours. **Cognitive effects** In a study of healthy volunteers, one dose of this agent caused decline in cognitive performance 40 minutes after administration. Compared to subjects ingesting a placebo, esketamine-treated subjects required a higher level of effort to complete assigned cognitive tests at 40 minutes after administration. Cognitive performance and mental effort were found to be similar between esketamine and placebo at 2 hours after administration. Reports of long-term memory or cognitive impairment have been made following repeated ketamine misuse or abuse. No adverse effects of esketamine nasal spray on cognitive function were seen in a one-year open-label safety study. The long-term cognitive effects of esketamine have not been studied for more than a 1 year period, therefore, the risk of cognitive decline with long-term use is not yet confirmed.


5.2 MeSH Pharmacological Classification

Antidepressive Agents

Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)


5.3 ATC Code

N06AX27


N - Nervous system

N01 - Anesthetics

N01A - Anesthetics, general

N01AX - Other general anesthetics

N01AX14 - Esketamine


N - Nervous system

N06 - Psychoanaleptics

N06A - Antidepressants

N06AX - Other antidepressants

N06AX27 - Esketamine


5.4 Absorption, Distribution and Excretion

Absorption

Due to the fact that this drug is administered via nasal spray, absorption is rapid. The mean absolute bioavailability is approximately 48% after esketamine nasal spray administration. The time to achieve peak esketamine plasma concentration is 20 to 40 minutes after the last nasal spray of esketamine. Inter-subject variability of esketamine ranges from 27% to 66% for Cmax (maximum concentration) and 18% to 45% for AUC (area under the curve). The intra-subject variability of esketamine is about 15% for Cmax and 10% for AUC.


Route of Elimination

Less than 1% of a dose of nasal esketamine is measured as unchanged drug, excreted in the urine. Following intravenous (IV) or oral (PO) administration, esketamine-derived metabolites were mainly recovered in urine ( 78% of a radiolabeled dose), and a smaller percentage was measured in the feces ( 2% of a radiolabeled dose).


Volume of Distribution

The average steady-state volume of distribution of esketamine administered by the intravenous route is 709 L.


Clearance

The average clearance of esketamine is approximately 89 L/hour following intravenous administration. Elimination of the major esketamine metabolite, _noresketamine_, from plasma is slower than esketamine. The decrease of noresketamine plasma concentrations occurs in a biphasic fashion, with a more rapid decline for the first 4 hours post-administration, and an average terminal t1/2 of approximately 8 hours.


5.5 Metabolism/Metabolites

Esketamine is mainly metabolized to the _noresketamine_ metabolite by cytochrome P450 (CYP) enzymes, CYP2B6 and CYP3A4, and to a lesser extent, CYP2C9 and CYP2C19. Noresketamine is metabolized by cytochrome-dependent metabolic pathways followed by subsequent glucuronidation of metabolites.


5.6 Biological Half-Life

The mean terminal half-life (t1/2) ranges from 7 to 12 hours.


5.7 Mechanism of Action

Esketamine, the S-enantiomer of racemic ketamine, is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. The exact mechanism by which esketamine acts as an antidepressant is unknown. The primary circulating metabolite of esketamine (_noresketamine_) shows activity at the same receptor with a weaker affinity.


API SUPPLIERS

read-more
read-more

01

Seqens

France

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

  • fda
  • EDQM
  • WHO-GMP

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

Flag France
Digital Content Digital Content
USDMF arrow-down Click Us! arrow-down
CEP/COS arrow-down JDMF EU-WC NDC arrow-down KDMF VMF ASMF, BR... arrow-down AUDIT
Seqens Company Banner

02

Supriya Lifescience

India

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content
USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF ASMF arrow-down AUDIT
Supriya

03

Supriya Lifescience

India

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF ASMF arrow-down AUDIT
Supriya

04

Nortec Quimica

Brazil

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

AAPS National Biotech
Not Confirmed
arrow

Nortec Quimica

Brazil

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

arrow
AAPS National Biotech
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
blank

05

Maithri Drugs

India

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

AAPS National Biotech
Not Confirmed
arrow

Maithri Drugs

India

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

arrow
AAPS National Biotech
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WC NDC KDMF VMF Others AUDIT
blank

06

Arevipharma

Germany

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

AAPS National Biotech
Not Confirmed
arrow

Arevipharma

Germany

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

arrow
AAPS National Biotech
Not Confirmed
USDMF arrow-down CEP/COS arrow-down JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
blank

07

Alkem Laboratories

India

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

AAPS National Biotech
Not Confirmed
arrow

Alkem Laboratories

India

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

arrow
AAPS National Biotech
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
blank

08

MSN Laboratories

India

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

AAPS National Biotech
Not Confirmed
arrow

MSN Laboratories

India

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

arrow
AAPS National Biotech
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
blank

09

Johnson & Johnson Innovative Medic...

U.S.A

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

AAPS National Biotech
Not Confirmed
arrow

Johnson & Johnson Innovative Medic...

U.S.A

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

arrow
AAPS National Biotech
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Drugs in Development

read-more
read-more

Details:

Esketamine HCl is a non-selective, non-competitive NMDA receptor antagonist, approved for treating mental illness.


Lead Product(s): Esketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 09, 2024

Supriya

01

Lead Product(s) : Esketamine Hydrochloride

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Esketamine HCl is a non-selective, non-competitive NMDA receptor antagonist, approved for treating mental illness.

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

December 09, 2024

Supriya

Details:

Spravato (esketamine) is an approved nasal spray formulation. It is a non-selective, non-competitive NMDA receptor antagonist for treating resistant major depressive disorder in adults.


Lead Product(s): Esketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Spravato

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 21, 2025

blank

02

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Spravato (esketamine) is an approved nasal spray formulation. It is a non-selective, non-competitive NMDA receptor antagonist for treating resistant major depressive disorder in adults.

Product Name : Spravato

Product Type : Controlled Substance

Upfront Cash : Inapplicable

January 21, 2025

blank

Details:

Spravato (esketamine) is an approved nasal spray formulation. It is a non-selective, non-competitive NMDA receptor antagonist for treating resistant major depressive disorder.


Lead Product(s): Esketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Spravato

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 22, 2024

blank

03

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Spravato (esketamine) is an approved nasal spray formulation. It is a non-selective, non-competitive NMDA receptor antagonist for treating resistant major depressive disorder.

Product Name : Spravato

Product Type : Controlled Substance

Upfront Cash : Inapplicable

July 22, 2024

blank

Details:

Spravato (esketamine) is the S-enantiomer of racemic ketamine and is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. It is being developed for treating resistant major depressive disorder.


Lead Product(s): Esketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Spravato

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 10, 2023

blank

04

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Spravato (esketamine) is the S-enantiomer of racemic ketamine and is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. It is being developed for treating resistant major depressive ...

Product Name : Spravato

Product Type : Controlled Substance

Upfront Cash : Inapplicable

August 10, 2023

blank

Details:

Spravato® (esketamine) is the S-enantiomer of racemic ketamine, is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. It is being developed for treating resistant major depressive disorder.


Lead Product(s): Esketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Spravato

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 27, 2023

blank

05

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Spravato® (esketamine) is the S-enantiomer of racemic ketamine, is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. It is being developed for treating resistant major depressive d...

Product Name : Spravato

Product Type : Controlled Substance

Upfront Cash : Inapplicable

March 27, 2023

blank

Details:

Spravato® (esketamine) is the S-enantiomer of racemic ketamine and is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. It is being developed for treating resistant major depressive disorder.


Lead Product(s): Esketamine Hydrochloride,Duloxetine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Spravato

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 23, 2022

blank

06

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : Spravato® (esketamine) is the S-enantiomer of racemic ketamine and is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. It is being developed for treating resistant major depressiv...

Product Name : Spravato

Product Type : Controlled Substance

Upfront Cash : Inapplicable

November 23, 2022

blank

Details:

First findings from the study support the short- and long-term use of SPRAVATO® (esketamine) nasal spray in adults living with treatment-resistant major depressive disorder in achieving remission and remaining relapse free.


Lead Product(s): Esketamine Hydrochloride,Undisclosed

Therapeutic Area: Psychiatry/Psychology Brand Name: Spravato

Study Phase: Phase IIIProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 23, 2022

blank

07

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : First findings from the study support the short- and long-term use of SPRAVATO® (esketamine) nasal spray in adults living with treatment-resistant major depressive disorder in achieving remission and remaining relapse free.

Product Name : Spravato

Product Type : Controlled Substance

Upfront Cash : Inapplicable

November 23, 2022

blank
  • Deals

Details:

Zilentin will purchase from Altamira, an option that entitles Zilentin to acquire Altamira’s remaining legacy assets in inner ear therapeutics, including AM-101 (tinnitus), AM-111, Keyzilen and Sonsuvi (hearing loss) and AM-125 (vertigo), for an upfront payment upon exercise.


Lead Product(s): Esketamine Hydrochloride

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Keyzilen

Study Phase: Phase IIIProduct Type: Controlled Substance

Sponsor: Altamira Therapeutics

Deal Size: $82.0 million Upfront Cash: $27.0 million

Deal Type: Divestment October 21, 2022

blank

08

Undisclosed

Country
arrow
AAPS National Biotech
Not Confirmed

Undisclosed

Country
arrow
AAPS National Biotech
Not Confirmed

Details : Zilentin will purchase from Altamira, an option that entitles Zilentin to acquire Altamira’s remaining legacy assets in inner ear therapeutics, including AM-101 (tinnitus), AM-111, Keyzilen and Sonsuvi (hearing loss) and AM-125 (vertigo), for an upfron...

Product Name : Keyzilen

Product Type : Controlled Substance

Upfront Cash : $27.0 million

October 21, 2022

blank

Details:

The first discussion titled Ketamine and Esketamine, is s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules), for the treatment of depression in adults who have tried other antidepressant medicines .


Lead Product(s): Esketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 18, 2022

blank

09

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : The first discussion titled Ketamine and Esketamine, is s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules), for the treatment of depression in adults who have tried other antidepressant medicines .

Product Name : Undisclosed

Product Type : Controlled Substance

Upfront Cash : Inapplicable

May 18, 2022

blank

Details:

SPRAVATO® (esketamine) CIII nasal spray is a nonselective, noncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor – an ionotropic glutamate receptor.


Lead Product(s): Esketamine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Spravato

Study Phase: Approved FDFProduct Type: Controlled Substance

Sponsor: Delic Corp

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 06, 2022

blank

10

AAPS National Biotech
Not Confirmed
AAPS National Biotech
Not Confirmed

Details : SPRAVATO® (esketamine) CIII nasal spray is a nonselective, noncompetitive antagonist of the N-methyl-D-aspartate (NMDA) receptor – an ionotropic glutamate receptor.

Product Name : Spravato

Product Type : Controlled Substance

Upfront Cash : Inapplicable

January 06, 2022

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

read-more
read-more

01

AAPS National Biotech
Not Confirmed
arrow
arrow
AAPS National Biotech
Not Confirmed

ESKETAMINE HYDROCHLORIDE

Brand Name : SPRAVATO

Dosage Form : SPRAY;NASAL

Dosage Strength : EQ 28MG BASE

Approval Date : 2019-03-05

Application Number : 211243

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Europe

read-more
read-more

01

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Esketamine

Brand Name : Spravato

Dosage Form : Nasal Spray

Dosage Strength : 28mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

02

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Esketamine

Brand Name : Spravato

Dosage Form : Nasal Spray

Dosage Strength : 28mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

03

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

Esketamine

Brand Name : Spravato

Dosage Form : Nasal Spray

Dosage Strength : 28mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

04

Pfizer

U.S.A
Arvo
Not Confirmed
arrow

Pfizer

U.S.A
arrow
Arvo
Not Confirmed

esketaminhydroklorid

Brand Name : Ketanest

Dosage Form : INJECTION / INFUSION

Dosage Strength : 5 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

05

Pfizer

U.S.A
Arvo
Not Confirmed
arrow

Pfizer

U.S.A
arrow
Arvo
Not Confirmed

esketaminhydroklorid

Brand Name : Ketanest

Dosage Form : INJECTION / INFUSION

Dosage Strength : 25 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content read-more

Create Content with PharmaCompass, ask us

STOCK RECAP #PipelineProspector

read-more
read-more

NEWS #PharmaBuzz

read-more
read-more

Global Sales Information

Do you need Business Intel? Ask us

Market Place

Do you need sourcing support? Ask us

Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

ABOUT THIS PAGE

Looking for 33643-46-8 / Esketamine Hydrochloride API manufacturers, exporters & distributors?

Esketamine Hydrochloride manufacturers, exporters & distributors 1

17

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

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

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

API | Excipient name

Esketamine Hydrochloride

Synonyms

(s)-ketamine, L-ketamine, (-)-ketamine, S-ketamine, 33643-46-8, (s)-(-)-ketamine

Cas Number

33643-46-8

Unique Ingredient Identifier (UNII)

50LFG02TXD

About Esketamine Hydrochloride

Esketamine is a cyclohexanone derivative and S-enantiomer of racemic ketamine, with analgesic, anesthetic and antidepressant activities. Although the mechanism of action is not fully understood, upon administration, esketamine targets, non-competitively binds to, and blocks N-methyl D-aspartate (NMDA) receptors. This reduces pain perception, induces sedation, and produce dissociative anesthesia.

esketamine HCl Manufacturers

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

esketamine HCl Suppliers

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

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

esketamine HCl USDMF

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

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

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

esketamine HCl CEP

A esketamine HCl CEP of the European Pharmacopoeia monograph is often referred to as a esketamine HCl Certificate of Suitability (COS). The purpose of a esketamine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of esketamine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of esketamine HCl to their clients by showing that a esketamine HCl CEP has been issued for it. The manufacturer submits a esketamine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a esketamine HCl CEP holder for the record. Additionally, the data presented in the esketamine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the esketamine HCl DMF.

A esketamine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. esketamine HCl CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of esketamine HCl suppliers with CEP (COS) on PharmaCompass.

esketamine HCl WC

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

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

esketamine HCl 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 esketamine HCl as an active pharmaceutical ingredient (API).

Finished drug products

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

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

esketamine HCl GMP

esketamine HCl 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 esketamine HCl 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 esketamine HCl GMP manufacturer or esketamine HCl GMP API supplier for your needs.

esketamine HCl CoA

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

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

esketamine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (esketamine HCl EP), esketamine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (esketamine HCl 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty