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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.)
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.
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
NDC Package Code : 73435-039
Start Marketing Date : 2025-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (60kg/60kg)
Marketing Category : BULK INGREDIENT
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
NDC Package Code : 58032-3002
Start Marketing Date : 2023-03-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
NDC Package Code : 62207-989
Start Marketing Date : 2025-07-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 17373-1021
Start Marketing Date : 2024-05-29
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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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,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 27, 2025

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Lead Product(s) : Viloxazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
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 : Miscellaneous
Upfront Cash : Inapplicable
January 27, 2025

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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,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Moksha8 Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 07, 2024

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Lead Product(s) : Viloxazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
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 : Miscellaneous
Upfront Cash : Undisclosed
May 07, 2024

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SPN-812 is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.
Lead Product(s): Viloxazine Hydrochloride,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 14, 2024

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Lead Product(s) : Viloxazine Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SPN-812 is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 14, 2024

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SPN-812 is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.
Lead Product(s): Viloxazine Hydrochloride,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 29, 2023

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Lead Product(s) : Viloxazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SPN-812 is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 29, 2023

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Viloxazine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Sleep Apnea, Obstructive.
Lead Product(s): Viloxazine Hydrochloride,AD816
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 31, 2023

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Lead Product(s) : Viloxazine Hydrochloride,AD816
Therapeutic Area : Sleep
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Viloxazine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Sleep Apnea, Obstructive.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 31, 2023

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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,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 29, 2022

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Lead Product(s) : Viloxazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Miscellaneous
Upfront Cash : Inapplicable
April 29, 2022

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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,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 02, 2021

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Lead Product(s) : Viloxazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Miscellaneous
Upfront Cash : Inapplicable
April 02, 2021

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SPN-812 is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.
Lead Product(s): Viloxazine Hydrochloride,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 08, 2021

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Lead Product(s) : Viloxazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SPN-812 is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 08, 2021

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Details:
SPN-812 is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.
Lead Product(s): Viloxazine Hydrochloride,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 04, 2021

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Lead Product(s) : Viloxazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
Details : SPN-812 is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 04, 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,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 22, 2021

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Lead Product(s) : Viloxazine Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Qelbree
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 22, 2021

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Patents & EXCLUSIVITIES
Patent Expiration Date : 2029-09-04
US Patent Number : 11324753
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 : 2029-09-04
US Patent Number : 11324753
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 : 2035-04-02
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 : 2035-04-02

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 : 11324753
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 : 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 : 2035-04-02
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 : 2035-04-02

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 : 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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Exclusivity Code : NCE
Exclusivity Expiration Date : 2026-04-02
Application Number : 211964
Product Number : 1
Exclusivity Details :

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Exclusivity Code : NCE
Exclusivity Expiration Date : 2026-04-02
Application Number : 211964
Product Number : 2
Exclusivity Details :

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Exclusivity Code : NCE
Exclusivity Expiration Date : 2026-04-02
Application Number : 211964
Product Number : 3
Exclusivity Details :

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
Viloxazine HCl reference standard
CAS Number : 35604-67-2
Quantity Per Vial :
Sale Unit :
Price :
Details :
Monograph :
Storage :
Code/Batch No :

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
11
PharmaCompass offers a list of Viloxazine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A DSSTox_CID_31511 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSSTox_CID_31511, including repackagers and relabelers. The FDA regulates DSSTox_CID_31511 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSSTox_CID_31511 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 DSSTox_CID_31511 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A DSSTox_CID_31511 supplier is an individual or a company that provides DSSTox_CID_31511 active pharmaceutical ingredient (API) or DSSTox_CID_31511 finished formulations upon request. The DSSTox_CID_31511 suppliers may include DSSTox_CID_31511 API manufacturers, exporters, distributors and traders.
click here to find a list of DSSTox_CID_31511 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A DSSTox_CID_31511 DMF (Drug Master File) is a document detailing the whole manufacturing process of DSSTox_CID_31511 active pharmaceutical ingredient (API) in detail. Different forms of DSSTox_CID_31511 DMFs exist exist since differing nations have different regulations, such as DSSTox_CID_31511 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DSSTox_CID_31511 DMF submitted to regulatory agencies in the US is known as a USDMF. DSSTox_CID_31511 USDMF includes data on DSSTox_CID_31511's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSSTox_CID_31511 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A DSSTox_CID_31511 written confirmation (DSSTox_CID_31511 WC) is an official document issued by a regulatory agency to a DSSTox_CID_31511 manufacturer, verifying that the manufacturing facility of a DSSTox_CID_31511 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DSSTox_CID_31511 APIs or DSSTox_CID_31511 finished pharmaceutical products to another nation, regulatory agencies frequently require a DSSTox_CID_31511 WC (written confirmation) as part of the regulatory process.
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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 DSSTox_CID_31511 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DSSTox_CID_31511 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 DSSTox_CID_31511 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 DSSTox_CID_31511 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DSSTox_CID_31511 NDC to their finished compounded human drug products, they may choose to do so.
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DSSTox_CID_31511 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 DSSTox_CID_31511 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right DSSTox_CID_31511 GMP manufacturer or DSSTox_CID_31511 GMP API supplier for your needs.
A DSSTox_CID_31511 CoA (Certificate of Analysis) is a formal document that attests to DSSTox_CID_31511's compliance with DSSTox_CID_31511 specifications and serves as a tool for batch-level quality control.
DSSTox_CID_31511 CoA mostly includes findings from lab analyses of a specific batch. For each DSSTox_CID_31511 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.
DSSTox_CID_31511 may be tested according to a variety of international standards, such as European Pharmacopoeia (DSSTox_CID_31511 EP), DSSTox_CID_31511 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DSSTox_CID_31511 USP).