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Chemistry

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Also known as: 35604-67-2, 2-((2-ethoxyphenoxy)methyl)morpholine hydrochloride, Viloxazine hcl, Vivalan, Emovit, Vicilan
Molecular Formula
C13H20ClNO3
Molecular Weight
273.75  g/mol
InChI Key
HJOCKFVCMLCPTP-UHFFFAOYSA-N
FDA UNII
OQW30I1332

Viloxazine Hydrochloride
A morpholine derivative used as an antidepressant. It is similar in action to IMIPRAMINE.
1 2D Structure

Viloxazine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[(2-ethoxyphenoxy)methyl]morpholine;hydrochloride
2.1.2 InChI
InChI=1S/C13H19NO3.ClH/c1-2-15-12-5-3-4-6-13(12)17-10-11-9-14-7-8-16-11;/h3-6,11,14H,2,7-10H2,1H3;1H
2.1.3 InChI Key
HJOCKFVCMLCPTP-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCOC1=CC=CC=C1OCC2CNCCO2.Cl
2.2 Other Identifiers
2.2.1 UNII
OQW30I1332
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Emovit

2. Ici-58,834

3. Ici58,834

4. Viloxazine

5. Viloxazine Hydrochloride, (r)-isomer

6. Viloxazine Hydrochloride, (s)-isomer

7. Viloxazine Oxalate (1:1)

8. Viloxazine, (+-)-isomer

9. Viloxazine, (r)-isomer

10. Viloxazine, (s)-isomer

11. Vivalan

2.3.2 Depositor-Supplied Synonyms

1. 35604-67-2

2. 2-((2-ethoxyphenoxy)methyl)morpholine Hydrochloride

3. Viloxazine Hcl

4. Vivalan

5. Emovit

6. Vicilan

7. 2-[(2-ethoxyphenoxy)methyl]morpholine Hydrochloride

8. Rac Viloxazine Hydrochloride

9. Viloxacina Clorhidrato

10. Ici 58,834

11. Viloxazine Hydrochloride [usan]

12. 2-((2-ethoxyphenoxy)methyl)morpholinehydrochloride

13. 2-[(2-ethoxyphenoxy)methyl]morpholine;hydrochloride

14. 2-((o-ethoxyphenoxy)methyl)morpholine Hydrochloride

15. Spn-812

16. Oqw30i1332

17. Qelbree

18. 2-[(2-ethoxy Phenoxy)methyl]morpholine Hydrochloride

19. Morpholine, 2-((2-ethoxyphenoxy)methyl)-, Hydrochloride

20. Morpholine, 2-[(2-ethoxyphenoxy)methyl]-, Hydrochloride

21. Ici-58834

22. Viloxazine Hydrochloride (usan)

23. Ccris 1915

24. Viloxacina Clorhidrato [spanish]

25. Einecs 252-638-6

26. Unii-oqw30i1332

27. Prestwick_734

28. Vivalan (tn)

29. Cloridrato De Viloxazina

30. 2-(2-ethoxyphenoxymethyl)tetrahydro-1,4-oxazine Hydrochloride

31. Chlorhydrate De Viloxazine

32. 2-(2-ethoxyphenoxymethyl)-2,3,5,6-tetrahydro-1,4-oxazine Hydrochloride

33. Dsstox_cid_31511

34. Dsstox_rid_97396

35. Dsstox_gsid_57722

36. Schembl300741

37. Chembl2106483

38. Dtxsid8057722

39. Glxc-25714

40. Tox21_113955

41. Viloxazine Hydrochloride [mi]

42. Akos015847050

43. At27980

44. Ccg-220828

45. Viloxazine Hydrochloride [mart.]

46. Ncgc00262964-01

47. Viloxazine Hydrochloride [who-dd]

48. Cas-35604-67-2

49. A6217

50. Ft-0675815

51. Ft-0675816

52. Ft-0675817

53. Ft-0675818

54. Ft-0675819

55. Viloxazine Hydrochloride [orange Book]

56. D02572

57. 2-(o-ethoxyphenoxymethyl)morpholine Hydrochloride

58. 604e672

59. Sr-01000872636

60. Sr-01000872636-1

61. W-110863

62. 2-(2-ethoxy-phenoxymethyl)-morpholine; Hydrochloride

63. 2-[(2-ethoxyphenoxy)-methyl]morpholine Hydrochloride

64. Q27285797

65. 2-(2-ethoxy-phenoxymethyl)-tetra-hydro-1,4-oxazine Hydrochloride

66. (+/-)-morpholine, 2-((2-ethoxyphenoxy)methyl)-, Hydrochloride

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 273.75 g/mol
Molecular Formula C13H20ClNO3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count5
Exact Mass273.1131712 g/mol
Monoisotopic Mass273.1131712 g/mol
Topological Polar Surface Area39.7 Ų
Heavy Atom Count18
Formal Charge0
Complexity213
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Antidepressive Agents, Second-Generation

A structurally and mechanistically diverse group of drugs that are not tricyclics or monoamine oxidase inhibitors. The most clinically important appear to act selectively on serotonergic systems, especially by inhibiting serotonin reuptake. (See all compounds classified as Antidepressive Agents, Second-Generation.)


Adrenergic Uptake Inhibitors

Drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants (ANTIDEPRESSIVE AGENTS, TRICYCLIC) and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin. (See all compounds classified as Adrenergic Uptake Inhibitors.)


4.2 FDA Pharmacological Classification
4.2.1 Pharmacological Classes
Cytochrome P450 2B6 Inhibitors [MoA]; Cytochrome P450 2D6 Inhibitors [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]; Norepinephrine Reuptake Inhibitor [EPC]; Norepinephrine Uptake Inhibitors [MoA]; Cytochrome P450 1A2 Inhibitors [MoA]

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ChemWerth Inc

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Metrochem API Private Limited

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Macsen Labs

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DMF Review : Complete

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Amsa Spa

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Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.
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Viloxazine Hydrochloride

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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Macsen Labs

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About the Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty Fine Chemicals. Our c...

Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty Fine Chemicals. Our comprehensive offerings extend to Contract Research & Custom Synthesis. With a legacy of over seven decades, Macsen combines tradition with innovation to meet the evolving needs of the chemical and pharmaceutical sectors. Our commitment to quality is evident in every aspect of our operations, from state-of-the-art manufacturing facilities to advanced analytical capabilities.
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Viloxazine Hydrochloride

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

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

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Viloxazine Hydrochloride

About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...

Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. From early discovery and development through manufacturing and commercialization, our suite of custom solutions allows us to tailor every engagement to your precise needs, whether that’s an independent project or an opportunity that cuts across the drug continuum.
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Viloxazine Hydrochloride

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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Symed Labs

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Viloxazine Hydrochloride

About the Company : Symed Labs Ltd is a leading Hyderabad based manufacturer of Active Pharmaceutical Ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemist...

Symed Labs Ltd is a leading Hyderabad based manufacturer of Active Pharmaceutical Ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemistry related services. We are more than 300 employees strong and our core competence is in the application of strong process chemistry to manufacturing in a regulatory environment. For the past 15 years, Symed has been at the forefront of facilitating and accelerating drug development (and GMP manufacturing) of APIs. The company's technical and scientific teams provide reliable solutions and services to the global pharmaceutical industry.
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[{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727202600,"product":"VILOXAZINE HYDROCHLORIDE","address":"PLOT NO. 193, HOUSE NO. 5-35\/50,","city":"HYDERABAD, AP","supplier":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","customerCountry":"UNITED STATES","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"1800","totalValueFC":"5173","currency":"USD","unitRateINR":144501.33333333334,"date":"25-Sep-2024","totalValueINR":"433504","totalValueInUsd":"5173","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4339969","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO. 193, HOUSE NO. 5-35\/50,, HYDERABAD, AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727634600,"product":"VILOXAZINE HYDROCHLORIDE","address":"PLOT NO. 193, HOUSE NO. 5-35\/50,","city":"HYDERABAD, AP","supplier":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","customerCountry":"UNITED STATES","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"1800","totalValueFC":"5173","currency":"USD","unitRateINR":144501.33333333334,"date":"30-Sep-2024","totalValueINR":"433504","totalValueInUsd":"5173","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4484422","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO. 193, HOUSE NO. 5-35\/50,, HYDERABAD, AP","customerAddress":""}]
25-Sep-2024
30-Sep-2024
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Drugs in Development

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Details:

Qelbree (viloxazine HCl) is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.


Lead Product(s): Viloxazine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 27, 2025

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Organic Process R&D
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Organic Process R&D
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Details : Qelbree (viloxazine HCl) is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Product Name : Qelbree

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 27, 2025

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Details:

An agreement aims to seek regulatory approval for Qelbree, an extended-release formulation of viloxazine for ADHD in children and adults.


Lead Product(s): Viloxazine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Moksha8 Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement May 07, 2024

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Organic Process R&D
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Organic Process R&D
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Details : An agreement aims to seek regulatory approval for Qelbree, an extended-release formulation of viloxazine for ADHD in children and adults.

Product Name : Qelbree

Product Type : Small molecule

Upfront Cash : Undisclosed

May 07, 2024

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Details:

At daily flexible-dose 200 to 600mg, Phase III trial met primary endpoint showing reduction change from baseline of Adult ADHD Investigator Symptom Rating Scale total score at end of study was statistically significantly greater in adults treated with Qelbree versus placebo.


Lead Product(s): Viloxazine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 29, 2022

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Organic Process R&D
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Organic Process R&D
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Details : At daily flexible-dose 200 to 600mg, Phase III trial met primary endpoint showing reduction change from baseline of Adult ADHD Investigator Symptom Rating Scale total score at end of study was statistically significantly greater in adults treated with Qe...

Product Name : Qelbree

Product Type : Small molecule

Upfront Cash : Not Applicable

April 29, 2022

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Details:

The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years.


Lead Product(s): Viloxazine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 02, 2021

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Organic Process R&D
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Organic Process R&D
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Details : The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years.

Product Name : Qelbree

Product Type : Small molecule

Upfront Cash : Not Applicable

April 02, 2021

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Details:

If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021.


Lead Product(s): Viloxazine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: SPN-812

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 22, 2021

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Organic Process R&D
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Organic Process R&D
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Details : If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021.

Product Name : SPN-812

Product Type : Small molecule

Upfront Cash : Not Applicable

February 22, 2021

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Details:

At a daily dose of SPN-812 up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale (AISRS).


Lead Product(s): Viloxazine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: SPN-812

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 22, 2020

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euroPLX 87
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euroPLX 87
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Details : At a daily dose of SPN-812 up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating...

Product Name : SPN-812

Product Type : Small molecule

Upfront Cash : Not Applicable

December 22, 2020

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Details:

SPN-812, if approved by the FDA, will be the first truly new therapy to treat ADHD in a decade


Lead Product(s): Viloxazine Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 22, 2020

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European Pharma Congress
Not Confirmed
European Pharma Congress
Not Confirmed

Details : SPN-812, if approved by the FDA, will be the first truly new therapy to treat ADHD in a decade

Product Name : Undisclosed

Product Type : Small molecule

Upfront Cash : Not Applicable

January 22, 2020

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INTERMEDIATE SUPPLIERS

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CAS Number : 926-39-6

End Use API : Viloxazine Hydrochloride

About The Company : Established in 2016, a state-of-the-art R&D facility engaged in the development of Novel processes for Bulk Actives including Deuterated Actives, Advanced Inter...

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European Pharma Congress
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CAS Number : 5296-35-5

End Use API : Viloxazine Hydrochloride

About The Company : Vihita Bio Chem is a rapidly growing and fully integrated company engaged in the manufacturing of drug intermediates, specialty chemicals, and fine chemicals. S...

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FDF Dossiers

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euroPLX 87
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VILOXAZINE HYDROCHLORIDE

Brand Name : QELBREE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2021-04-02

Application Number : 211964

Regulatory Info : RX

Registration Country : USA

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euroPLX 87
Not Confirmed
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euroPLX 87
Not Confirmed

VILOXAZINE HYDROCHLORIDE

Brand Name : QELBREE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 150MG BASE

Packaging :

Approval Date : 2021-04-02

Application Number : 211964

Regulatory Info : RX

Registration Country : USA

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euroPLX 87
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euroPLX 87
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VILOXAZINE HYDROCHLORIDE

Brand Name : QELBREE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 200MG BASE

Packaging :

Approval Date : 2021-04-02

Application Number : 211964

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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01

Bacteriophage Summit
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Bacteriophage Summit
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VILOXAZINE HYDROCHLORIDE

Brand Name : QELBREE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2021-04-02

Application Number : 211964

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Bacteriophage Summit
Not Confirmed
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Bacteriophage Summit
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VILOXAZINE HYDROCHLORIDE

Brand Name : QELBREE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2021-04-02

Application Number : 211964

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Bacteriophage Summit
Not Confirmed
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Bacteriophage Summit
Not Confirmed

VILOXAZINE HYDROCHLORIDE

Brand Name : QELBREE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 2021-04-02

Application Number : 211964

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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DATA COMPILATION #PharmaFlow

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NEWS #PharmaBuzz

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Global Sales Information

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Market Place

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APIs

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Patents & EXCLUSIVITIES

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US Patents

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VILOXAZINE HYDROCHLORIDE

US Patent Number : 9662338

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 211964

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-02-07

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Organic Process R&D
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VILOXAZINE HYDROCHLORIDE

US Patent Number : 9603853

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2033-02-07

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Organic Process R&D
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VILOXAZINE HYDROCHLORIDE

US Patent Number : 12121523

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2029-09-04

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Organic Process R&D
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VILOXAZINE HYDROCHLORIDE

US Patent Number : 9603853

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2033-02-07

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Organic Process R&D
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VILOXAZINE HYDROCHLORIDE

US Patent Number : 12121523

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2029-09-04

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Organic Process R&D
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VILOXAZINE HYDROCHLORIDE

US Patent Number : 9603853

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2033-02-07

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VILOXAZINE HYDROCHLORIDE

US Patent Number : 11458143

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2029-09-04

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Organic Process R&D
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VILOXAZINE HYDROCHLORIDE

US Patent Number : 9358204

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 211964

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-02-07

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Organic Process R&D
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VILOXAZINE HYDROCHLORIDE

US Patent Number : 11458143

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2029-09-04

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Organic Process R&D
Not Confirmed
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Organic Process R&D
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VILOXAZINE HYDROCHLORIDE

US Patent Number : 9358204

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 211964

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-02-07

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US Exclusivities

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REF. STANDARDS & IMPURITIES

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ABOUT THIS PAGE

Looking for 35604-67-2 / Viloxazine Hydrochloride API manufacturers, exporters & distributors?

Viloxazine Hydrochloride manufacturers, exporters & distributors 1

69

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

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

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

API | Excipient name

Viloxazine Hydrochloride

Synonyms

35604-67-2, 2-((2-ethoxyphenoxy)methyl)morpholine hydrochloride, Viloxazine hcl, Vivalan, Emovit, Vicilan

Cas Number

35604-67-2

Unique Ingredient Identifier (UNII)

OQW30I1332

About Viloxazine Hydrochloride

A morpholine derivative used as an antidepressant. It is similar in action to IMIPRAMINE.

Viloxazine Hydrochloride Manufacturers

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

Viloxazine Hydrochloride Suppliers

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

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

Viloxazine Hydrochloride USDMF

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

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

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

Viloxazine Hydrochloride 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 Viloxazine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Viloxazine Hydrochloride GMP

Viloxazine Hydrochloride 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 Viloxazine Hydrochloride 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 Viloxazine Hydrochloride GMP manufacturer or Viloxazine Hydrochloride GMP API supplier for your needs.

Viloxazine Hydrochloride CoA

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

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

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