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1. 139603, Ly
2. Atomoxetine
3. Atomoxetine Hcl
4. Hcl, Atomoxetine
5. Hydrochloride, Atomoxetine
6. Ly 139603
7. N-methyl-gamma-(2-methylphenoxy)benzenepropanamine Hydrochloride
8. Strattera
9. Tomoxetine
10. Tomoxetine Hydrochloride, (+)-isomer - T351671
11. Tomoxetine Hydrochloride, (+-)-isomer
12. Tomoxetine Hydrochloride, (-)-isomer
1. Atomoxetine Hcl
2. 82248-59-7
3. Tomoxetine Hydrochloride
4. Strattera
5. (r)-tomoxetine Hydrochloride
6. (r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine Hydrochloride
7. Atomoxetine, Hcl
8. Atomoxetine Hydrochloride [usan]
9. (r)-(-)-tomoxetine Hydrochloride
10. Ly 139603
11. Atomoxetine (hydrochloride)
12. Ly-139603
13. Atomoxetine (as Hydrochloride)
14. 57wvb6i2w0
15. (-)-n-methyl-3-phenyl-3-(o-tolyloxy)propylamine Hydrochloride
16. Chebi:331697
17. (r)-atomoxetine Hydrochloride
18. Nsc-759104
19. Dsstox_cid_24266
20. Dsstox_rid_80136
21. Dsstox_gsid_44266
22. Smr000469177
23. Cas-82248-59-7
24. Unii-57wvb6i2w0
25. (3r)-n-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine;hydrochloride
26. Strattera (tn)
27. Mfcd06410992
28. Ncgc00016056-02
29. Chembl1702
30. Mls001401377
31. Mls002153176
32. Schembl122111
33. Atomoxetine Hcl [vandf]
34. Dtxsid2044266
35. Atomoxetine Hydrochloride- Bio-x
36. Atomoxetine Hydrochloride Solution
37. Ly 139603 Hcl
38. Hms3413c05
39. Hms3677c05
40. (r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-aminehydrochloride
41. (r)-tomoxetine Hydrochloride, Solid
42. Tox21_110292
43. Atomoxetine Hydrochloride (jan/usp)
44. Ly-139602 [(+)-isomer]
45. S3175
46. Atomoxetine Hydrochloride [mi]
47. (3r)-n-methyl-3-(2-methylphenoxy)-3-phenylpropan-1-amine Hydrochloride
48. Akos015920150
49. Benzenepropanamine, N-methyl-gamma-(2-methylphenoxy)-, Hydrochloride, (-)-
50. Tox21_110292_1
51. Atomoxetine Hydrochloride [jan]
52. Ccg-100874
53. Cs-1085
54. Ks-1223
55. Nc00124
56. Nsc 759104
57. Atomoxetine For Impurity A Identification
58. Atomoxetine Hydrochloride [mart.]
59. Ncgc00025345-02
60. Atomoxetine Hydrochloride [usp-rs]
61. Atomoxetine Hydrochloride [who-dd]
62. Bm164222
63. Hy-17385
64. Ly-135252
65. Am20060733
66. Sw197504-3
67. Atomoxetine Hydrochloride [ep Monograph]
68. Atomoxetine Hydrochloride [orange Book]
69. D02574
70. Atomoxetine Hydrochloride [usp Monograph]
71. 248t597
72. Sr-01000597779
73. Sr-01000763397
74. Sr-01000597779-1
75. Sr-01000763397-3
76. Q27225729
77. F0001-2408
78. Atomoxetine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)
79. (r)-n-methyl-?-(2-methylphenoxy)-benzenepropanamine Hydrochloride
80. (r)-n-methyl-3-(2-methylphenoxy)-3-phenylpropylamine Hydrochloride
81. (r)-n-methyl-3-phenyl-3-(o-tolyloxy)-propan-1-amine Hydrochloride
82. (r)-n-methyl-3-phenyl-3-(o-tolyloxy)propan-1-amine Hcl
83. (r)-(-)-n-methyl-3-(2-methylphenoxy)-3-phenylpropylamine Hydrochloride
84. (r)-n-methyl-gamma-(2-methylphenoxy)-benzenepropanamine Hydrochloride
85. Atomoxetine Hydrochloride, European Pharmacopoeia (ep) Reference Standard
86. Methyl-((r)-3-phenyl-3-o-tolyloxy-propyl)-amine Hydrochloride
87. Atomoxetine For Impurity A Identification, European Pharmacopoeia (ep) Reference Standard
88. Atomoxetine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
89. Atomoxetine Hydrochloride, United States Pharmacopeia (usp) Reference Standard
90. Benzenepropanamine, N-methyl-.gamma.-(2-methylphenoxy)-, Hydrochloride, (-)
91. Atomoxetine Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material
Molecular Weight | 291.8 g/mol |
---|---|
Molecular Formula | C17H22ClNO |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 6 |
Exact Mass | 291.1389920 g/mol |
Monoisotopic Mass | 291.1389920 g/mol |
Topological Polar Surface Area | 21.3 Ų |
Heavy Atom Count | 20 |
Formal Charge | 0 |
Complexity | 237 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 4 | |
---|---|
Drug Name | Atomoxetine hydrochloride |
Drug Label | STRATTERA (atomoxetineHCl) is a selective norepinephrine reuptake inhibitor. AtomoxetineHCl is the R(-) isomer as determined by xray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The... |
Active Ingredient | Atomoxetine hydrochloride |
Dosage Form | Capsule |
Route | oral |
Strength | 18mg; 100mg; 25mg; 60mg; 10mg; 80mg; 40mg |
Market Status | Tentative Approval |
Company | Mylan Pharms; Glenmark Generics; Aurobindo Pharma Usa; Apotex; Dr Reddys Labs; Sandoz; Sun Pharma Global |
2 of 4 | |
---|---|
Drug Name | Strattera |
PubMed Health | Atomoxetine (By mouth) |
Drug Classes | Central Nervous System Agent |
Drug Label | STRATTERA (atomoxetineHCl) is a selective norepinephrine reuptake inhibitor. AtomoxetineHCl is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The m... |
Active Ingredient | Atomoxetine hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | 18mg; 25mg; 100mg; 60mg; 10mg; 80mg; 40mg |
Market Status | Prescription |
Company | Lilly |
3 of 4 | |
---|---|
Drug Name | Atomoxetine hydrochloride |
Drug Label | STRATTERA (atomoxetineHCl) is a selective norepinephrine reuptake inhibitor. AtomoxetineHCl is the R(-) isomer as determined by xray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The... |
Active Ingredient | Atomoxetine hydrochloride |
Dosage Form | Capsule |
Route | oral |
Strength | 18mg; 100mg; 25mg; 60mg; 10mg; 80mg; 40mg |
Market Status | Tentative Approval |
Company | Mylan Pharms; Glenmark Generics; Aurobindo Pharma Usa; Apotex; Dr Reddys Labs; Sandoz; Sun Pharma Global |
4 of 4 | |
---|---|
Drug Name | Strattera |
PubMed Health | Atomoxetine (By mouth) |
Drug Classes | Central Nervous System Agent |
Drug Label | STRATTERA (atomoxetineHCl) is a selective norepinephrine reuptake inhibitor. AtomoxetineHCl is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The m... |
Active Ingredient | Atomoxetine hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | 18mg; 25mg; 100mg; 60mg; 10mg; 80mg; 40mg |
Market Status | Prescription |
Company | Lilly |
Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
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.)
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic. It is being evaluated in phase 3 clinial trials for treating obstructive sleep apnea.
Lead Product(s): Oxybutynin,Atomoxetin Hydrochloride
Therapeutic Area: Sleep Brand Name: AD109
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2024
Lead Product(s) : Oxybutynin,Atomoxetin Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Apnimed Completes Enrollment in Phase 3 Study of AD109 for Obstructive Sleep Apnea
Details : AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic. It is being evaluated in phase 3 clinial trials for treating obstructive sleep apnea.
Brand Name : AD109
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 19, 2024
Details:
AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective NRI, atomoxetine. It is being evaluated for the treatment of obstructive sleep apnea.
Lead Product(s): Oxybutynin,Atomoxetin Hydrochloride
Therapeutic Area: Sleep Brand Name: AD109
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2024
Lead Product(s) : Oxybutynin,Atomoxetin Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Apnimed Completes Enrollment in Phase 3 LunAIRo Study Of AD109
Details : AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective NRI, atomoxetine. It is being evaluated for the treatment of obstructive sleep apnea.
Brand Name : AD109
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 09, 2024
Details:
AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective norepinephrine reuptake inhibitor (NRI), atomoxetine. It is being evaluated in phase 3 clinial trials for the treatment of Obstructive Sleep Apnea.
Lead Product(s): Aroxybutynin,Atomoxetin Hydrochloride
Therapeutic Area: Sleep Brand Name: AD109
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2023
Lead Product(s) : Aroxybutynin,Atomoxetin Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective norepinephrine reuptake inhibitor (NRI), atomoxetine. It is being evaluated in phase 3 clinial trials for the treatment of Obstructive Sleep ...
Brand Name : AD109
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 21, 2023
Details:
AD109 (atomoxetine) has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy.
Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area: Sleep Brand Name: AD109
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2023
Lead Product(s) : Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : AD109 (atomoxetine) has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy.
Brand Name : AD109
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 21, 2023
Details:
AD109 (atomoxetine) has the potential to be the first oral pharmacologic that both treats the underlying cause of OSA, airway obstruction at night, and improves daytime consequences of OSA such as fatigue.
Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area: Sleep Brand Name: AD109
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Alpha Wave Ventures
Deal Size: $79.7 million Upfront Cash: Undisclosed
Deal Type: Series C Financing January 03, 2023
Lead Product(s) : Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area : Sleep
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Alpha Wave Ventures
Deal Size : $79.7 million
Deal Type : Series C Financing
Details : AD109 (atomoxetine) has the potential to be the first oral pharmacologic that both treats the underlying cause of OSA, airway obstruction at night, and improves daytime consequences of OSA such as fatigue.
Brand Name : AD109
Molecule Type : Small molecule
Upfront Cash : Undisclosed
January 03, 2023
Details:
AD109 (atomoxetine) is first oral pharmacologic that treats OSA airway obstruction at night. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity.
Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area: Sleep Brand Name: AD109
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2022
Lead Product(s) : Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area : Sleep
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : AD109 (atomoxetine) is first oral pharmacologic that treats OSA airway obstruction at night. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease s...
Brand Name : AD109
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 28, 2022
Details:
AD504 (Atomoxetine) showed a significant reduction of the Apnea Hypopnea Index (AHI) (from 18.2 [11.8 to 31.3] on placebo to 7.4 [5.4 to 16.1] events/h on AD504, p=0.024 and Hypoxic Burden (HB) from 46.3 [25.1 to 88.3] on placebo to 18.7 [14.9 to 43.5], p=0.003 on AD504.
Lead Product(s): Atomoxetin Hydrochloride,Trazodone Hydrochloride
Therapeutic Area: Sleep Brand Name: AD504
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Lead Product(s) : Atomoxetin Hydrochloride,Trazodone Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : AD504 (Atomoxetine) showed a significant reduction of the Apnea Hypopnea Index (AHI) (from 18.2 [11.8 to 31.3] on placebo to 7.4 [5.4 to 16.1] events/h on AD504, p=0.024 and Hypoxic Burden (HB) from 46.3 [25.1 to 88.3] on placebo to 18.7 [14.9 to 43.5], ...
Brand Name : AD504
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 02, 2022
Details:
Positive data on investigational oral pharmacologic treatment AD109 showed statistically significant and clinically meaningful benefits for patients with obstructive sleep apnea.
Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area: Sleep Brand Name: AD109
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2022
Lead Product(s) : Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area : Sleep
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Apnimed Study APC-004 Phase 2 Data to be Presented at World Sleep 2022
Details : Positive data on investigational oral pharmacologic treatment AD109 showed statistically significant and clinically meaningful benefits for patients with obstructive sleep apnea.
Brand Name : AD109
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 09, 2022
Details:
AD504 (atomoxetine plus trazodone) showed a strong trend in the reduction in apnea hypopnea index (AHI) from placebo, which was the study’s primary endpoint.
Lead Product(s): Atomoxetin Hydrochloride,Trazodone Hydrochloride
Therapeutic Area: Sleep Brand Name: AD504
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2021
Lead Product(s) : Atomoxetin Hydrochloride,Trazodone Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : AD504 (atomoxetine plus trazodone) showed a strong trend in the reduction in apnea hypopnea index (AHI) from placebo, which was the study’s primary endpoint.
Brand Name : AD504
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 16, 2021
Details:
The proceeds will support Apnimed’s ongoing development and commercialization plans. The company is advancing its lead program, AD109, an oral disease-modifying therapeutic for the treatment of Obstructive Sleep Apnea, which is currently in late-stage Phase 2 clinical trials.
Lead Product(s): Aroxybutynin,Atomoxetin Hydrochloride
Therapeutic Area: Sleep Brand Name: AD109
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Morningside Ventures
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing March 25, 2021
Lead Product(s) : Aroxybutynin,Atomoxetin Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Morningside Ventures
Deal Size : $25.0 million
Deal Type : Series B Financing
Details : The proceeds will support Apnimed’s ongoing development and commercialization plans. The company is advancing its lead program, AD109, an oral disease-modifying therapeutic for the treatment of Obstructive Sleep Apnea, which is currently in late-stage ...
Brand Name : AD109
Molecule Type : Small molecule
Upfront Cash : Undisclosed
March 25, 2021
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Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
A Atomoxetine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atomoxetine Hydrochloride, including repackagers and relabelers. The FDA regulates Atomoxetine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atomoxetine 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 Atomoxetine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Atomoxetine Hydrochloride supplier is an individual or a company that provides Atomoxetine Hydrochloride active pharmaceutical ingredient (API) or Atomoxetine Hydrochloride finished formulations upon request. The Atomoxetine Hydrochloride suppliers may include Atomoxetine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Atomoxetine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Atomoxetine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Atomoxetine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Atomoxetine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Atomoxetine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atomoxetine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Atomoxetine Hydrochloride USDMF includes data on Atomoxetine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atomoxetine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atomoxetine Hydrochloride suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Atomoxetine Hydrochloride Drug Master File in Japan (Atomoxetine Hydrochloride JDMF) empowers Atomoxetine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Atomoxetine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Atomoxetine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Atomoxetine Hydrochloride suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Atomoxetine Hydrochloride Drug Master File in Korea (Atomoxetine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atomoxetine Hydrochloride. The MFDS reviews the Atomoxetine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Atomoxetine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Atomoxetine Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Atomoxetine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Atomoxetine Hydrochloride suppliers with KDMF on PharmaCompass.
A Atomoxetine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Atomoxetine Hydrochloride Certificate of Suitability (COS). The purpose of a Atomoxetine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Atomoxetine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Atomoxetine Hydrochloride to their clients by showing that a Atomoxetine Hydrochloride CEP has been issued for it. The manufacturer submits a Atomoxetine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Atomoxetine Hydrochloride CEP holder for the record. Additionally, the data presented in the Atomoxetine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Atomoxetine Hydrochloride DMF.
A Atomoxetine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Atomoxetine Hydrochloride 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 Atomoxetine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Atomoxetine Hydrochloride written confirmation (Atomoxetine Hydrochloride WC) is an official document issued by a regulatory agency to a Atomoxetine Hydrochloride manufacturer, verifying that the manufacturing facility of a Atomoxetine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Atomoxetine Hydrochloride APIs or Atomoxetine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Atomoxetine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Atomoxetine Hydrochloride suppliers with Written Confirmation (WC) 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 Atomoxetine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Atomoxetine 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 Atomoxetine 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 Atomoxetine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atomoxetine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Atomoxetine Hydrochloride suppliers with NDC on PharmaCompass.
Atomoxetine 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 Atomoxetine 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 Atomoxetine Hydrochloride GMP manufacturer or Atomoxetine Hydrochloride GMP API supplier for your needs.
A Atomoxetine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Atomoxetine Hydrochloride's compliance with Atomoxetine Hydrochloride specifications and serves as a tool for batch-level quality control.
Atomoxetine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Atomoxetine 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.
Atomoxetine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Atomoxetine Hydrochloride EP), Atomoxetine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atomoxetine Hydrochloride USP).
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