Synopsis
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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
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
Molecular Weight | 273.75 g/mol |
---|---|
Molecular Formula | C13H20ClNO3 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 5 |
Exact Mass | 273.1131712 g/mol |
Monoisotopic Mass | 273.1131712 g/mol |
Topological Polar Surface Area | 39.7 Ų |
Heavy Atom Count | 18 |
Formal Charge | 0 |
Complexity | 213 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
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.)
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-01-24
Pay. Date : 2024-12-24
DMF Number : 39333
Submission : 2023-12-30
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39582
Submission : 2024-03-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-01-29
Pay. Date : 2024-11-29
DMF Number : 40737
Submission : 2024-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39715
Submission : 2024-06-04
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-12-13
Pay. Date : 2024-10-31
DMF Number : 40485
Submission : 2024-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37560
Submission : 2022-09-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-12-17
Pay. Date : 2024-11-22
DMF Number : 38637
Submission : 2023-08-25
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-01-24
Pay. Date : 2024-12-24
DMF Number : 39333
Submission : 2023-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40004
Submission : 2024-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39799
Submission : 2024-05-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-17
Pay. Date : 2024-10-21
DMF Number : 40648
Submission : 2024-11-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-21
Pay. Date : 2024-05-10
DMF Number : 39826
Submission : 2024-04-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39582
Submission : 2024-03-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-13
Pay. Date : 2024-10-31
DMF Number : 40485
Submission : 2024-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-17
Pay. Date : 2024-11-22
DMF Number : 38637
Submission : 2023-08-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37560
Submission : 2022-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39715
Submission : 2024-06-04
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
NDC Package Code : 51504-0023
Start Marketing Date : 2020-03-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 58032-3002
Start Marketing Date : 2023-03-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17373-1021
Start Marketing Date : 2024-05-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84386-014
Start Marketing Date : 2024-10-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65089-0064
Start Marketing Date : 2023-03-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71666-015
Start Marketing Date : 2023-08-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 70600-039
Start Marketing Date : 2022-09-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71666-016
Start Marketing Date : 2023-09-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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...
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
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...
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...
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...
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...
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...
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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
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Supernus Updates Qelbree Label for ADHD & Breastfeeding Data
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
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
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Moksha8 Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
M8 Pharmaceuticals Signs Exclusive Licensing Agreement for Qelbree® in Latin America
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
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
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Supernus Announces FDA Approval of Qelbree for the Treatment of ADHD in Adults
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
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
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Supernus Announces FDA Approval of Qelbree™ (SPN-812) for the Treatment of ADHD
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
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
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Supernus Receives FDA Notice Assigning Early April 2021 PDUFA Date for SPN-812 NDA
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
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
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Supernus Announces Positive Results from Phase III Study for SPN-812 in Adults with ADHD
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
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
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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
2-Aminoethyl hydrogen sulphate
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...
2-(2- Ethoryphenoxymethyl)oxirane
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...
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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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Patents & EXCLUSIVITIES
Patent Expiration Date : 2033-02-07
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
Patent Expiration Date : 2033-02-07
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
Patent Expiration Date : 2029-09-04
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
Patent Expiration Date : 2033-02-07
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
Patent Expiration Date : 2029-09-04
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
Patent Expiration Date : 2033-02-07
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
Patent Expiration Date : 2029-09-04
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
Patent Expiration Date : 2033-02-07
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
Patent Expiration Date : 2029-09-04
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
Patent Expiration Date : 2033-02-07
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
Exclusivity Code : NCE
Exclusivity Expiration Date : 2026-04-02
Application Number : 211964
Product Number : 2
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2025-04-29
Application Number : 211964
Product Number : 2
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2026-04-02
Application Number : 211964
Product Number : 3
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2025-04-29
Application Number : 211964
Product Number : 3
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2026-04-02
Application Number : 211964
Product Number : 1
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2025-04-29
Application Number : 211964
Product Number : 1
Exclusivity Details :
REF. STANDARDS & IMPURITIES
Viloxazine HCl reference standard
CAS Number : 35604-67-2
Quantity Per Vial :
Sale Unit :
Price :
Details :
Monograph :
Storage :
Code/Batch No :
ABOUT THIS PAGE
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.
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.
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.
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.
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).
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.
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.
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 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.
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).