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1. Cymbalta
2. Duloxetine
3. Duloxetine Ethanedioate (1:1), (+-)-isomer - T353987
4. Duloxetine Hcl
5. Duloxetine, (+)-isomer
6. Hcl, Duloxetine
7. Hydrochloride, Duloxetine
8. Ly 227942
9. Ly 248686
10. Ly-227942
11. Ly-248686
12. Ly227942
13. Ly248686
14. N-methyl-3-(1-naphthalenyloxy)-2-thiophenepropanamine
15. N-methyl-3-(1-naphthalenyloxy)-3-(2-thiophene)propanamide
1. 136434-34-9
2. Duloxetine Hcl
3. Cymbalta
4. (s)-duloxetine Hydrochloride
5. Ariclaim
6. Xeristar
7. (s)-n-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Hydrochloride
8. Duloxetine Hydrochloride [usan]
9. Duloxetine Mylan
10. Duloxetine (hydrochloride)
11. Ly248686 Hcl
12. Ly-248686 Hcl
13. Nsc-759112
14. Cpd000469136
15. Duloxetine (as Hydrochloride)
16. Chebi:31526
17. (3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine;hydrochloride
18. 9044sc542w
19. Yentreve (tn)
20. (+)-(s)-n-methyl-gamma-(1-naphthyloxy)-2-thiophenepropylamine Hydrochloride
21. Dsstox_cid_26443
22. Dsstox_rid_81618
23. Dsstox_gsid_46443
24. Duloxetine Boehringer Ingelheim
25. Methyl[3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]amine Hydrochloride
26. (+)-(s)-n-methyl-.gamma.-(1-naphthyloxy)-2-thiophenepropylamine Hydrochloride
27. (s)-n-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Hcl
28. Smr000469136
29. Dulane 20
30. Cas-136434-34-9
31. Ncgc00164559-01
32. C18h19nos.hcl
33. Unii-9044sc542w
34. Ly 248686 Hcl
35. Cymbalta (tn)
36. Duloxetina Cloridrato
37. Duloxetine Hydrochlorise
38. Duloxetine Lilly
39. Cloridrato De Duloxetina
40. Clorhidrato De Duloxetina
41. Chlorhydrate De Duloxetine
42. Duloxetine Hcl (cymbalta)
43. Mls001401452
44. Mls006010054
45. (s)-duloxetine (hydrochloride)
46. Duloxetine Hydrochloride- Bio-x
47. Chembl1200328
48. Dtxsid9046443
49. Duloxetine Hydrochloride Solution
50. Duloxetine For System Suitability
51. Hy-b0161a
52. Pharmakon1600-01505387
53. Ly-248686 Hydrochloride
54. Amy12420
55. Duloxetine Hydrochloride (jan/usp)
56. Tox21_112188
57. Ac-924
58. Duloxetine Hydrochloride [mi]
59. Mfcd06407958
60. Nsc744012
61. Nsc759112
62. S2084
63. Duloxetine Hydrochloride [jan]
64. (3s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine Hydrochloride
65. Akos016340453
66. Tox21_112188_1
67. Ccg-101106
68. Cs-1993
69. Ks-1168
70. Nc00356
71. Nsc 759112
72. Nsc-744012
73. (3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine Hydrochloride
74. 2-thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, Hydrochloride, (gammas)-
75. 2-thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, Hydrochloride, (s)-
76. Duloxetine Hydrochloride [mart.]
77. Duloxetine Hydrochloride [usp-rs]
78. Duloxetine Hydrochloride [who-dd]
79. Ncgc00164559-03
80. (s)-(+)-duloxetine Hydrochloride
81. Bd165546
82. Ly-264453
83. D-170
84. D4223
85. Sw197393-3
86. Duloxetine Hydrochloride [orange Book]
87. (s)-duloxetine Hydrochloride, >=98% (hplc)
88. D01179
89. Duloxetine Hydrochloride [ep Monograph]
90. Duloxetine Hydrochloride [usp Monograph]
91. 434d349
92. Q-102508
93. Duloxetine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)
94. (+)-(s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propanamine Hydrochloride
95. Duloxetine Hydrochloride, European Pharmacopoeia (ep) Reference Standard
96. (+)-(s)-n-methyl-3-(1-naphthyloxy)- 3-(2-thienyl)propanamine Hydrochloride
97. (3s)-n-methyl-3-(naphthalen-1-yloxy)-3-(2-thienyl)propan-1-amine Hydrochloride
98. (3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amin Hydrochloride.
99. (gammas)-2-thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)hydrochloride (1:1)
100. (gammas)-n-methyl-gamma-(1-naphthalenyloxy)-2-thiophenepropanamine Hydrochloride
101. (s)-(+)-n-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl) Propanamine Hydrochloride
102. (s)-(+)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine Hydrochloride
103. 2-thiophenepropanamine, N-methyl-.gamma.-(1-naphthalenyloxy)-, Hydrochloride, (s)-
104. Duloxetine For System Suitability, European Pharmacopoeia (ep) Reference Standard
105. Duloxetine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
106. Duloxetine Hydrochloride, United States Pharmacopeia (usp) Reference Standard
| Molecular Weight | 333.9 g/mol |
|---|---|
| Molecular Formula | C18H20ClNOS |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 6 |
| Exact Mass | 333.0954131 g/mol |
| Monoisotopic Mass | 333.0954131 g/mol |
| Topological Polar Surface Area | 49.5 Ų |
| Heavy Atom Count | 22 |
| Formal Charge | 0 |
| Complexity | 312 |
| 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 | Cymbalta |
| PubMed Health | Duloxetine (By mouth) |
| Drug Classes | Antidepressant, Central Nervous System Agent, Neuropathic Pain Agent |
| Drug Label | Cymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e... |
| Active Ingredient | Duloxetine hydrochloride |
| Dosage Form | Capsule, delayed rel pellets |
| Route | oral; Oral |
| Strength | eq 30mg base; eq 20mg base; eq 60mg base |
| Market Status | Prescription |
| Company | Lilly |
| 2 of 4 | |
|---|---|
| Drug Name | Duloxetine hydrochloride |
| Drug Label | Cymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e... |
| Active Ingredient | Duloxetine hydrochloride |
| Dosage Form | Capsule, delayed rel pellets; Capsule, delayed release |
| Route | oral; Oral |
| Strength | eq 40mg base; 60mg; 30mg; eq 30mg base; eq 20mg base; eq 60mg base; 20mg |
| Market Status | Tentative Approval; Prescription |
| Company | Wockhardt; Actavis Elizabeth; Breckenridge Pharm; Apotex; Alembic Pharms; Teva Pharms Usa; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Lupin; Dr Reddys Labs; Sandoz; Sun Pharma Global; Impax Labs |
| 3 of 4 | |
|---|---|
| Drug Name | Cymbalta |
| PubMed Health | Duloxetine (By mouth) |
| Drug Classes | Antidepressant, Central Nervous System Agent, Neuropathic Pain Agent |
| Drug Label | Cymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e... |
| Active Ingredient | Duloxetine hydrochloride |
| Dosage Form | Capsule, delayed rel pellets |
| Route | oral; Oral |
| Strength | eq 30mg base; eq 20mg base; eq 60mg base |
| Market Status | Prescription |
| Company | Lilly |
| 4 of 4 | |
|---|---|
| Drug Name | Duloxetine hydrochloride |
| Drug Label | Cymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e... |
| Active Ingredient | Duloxetine hydrochloride |
| Dosage Form | Capsule, delayed rel pellets; Capsule, delayed release |
| Route | oral; Oral |
| Strength | eq 40mg base; 60mg; 30mg; eq 30mg base; eq 20mg base; eq 60mg base; 20mg |
| Market Status | Tentative Approval; Prescription |
| Company | Wockhardt; Actavis Elizabeth; Breckenridge Pharm; Apotex; Alembic Pharms; Teva Pharms Usa; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Lupin; Dr Reddys Labs; Sandoz; Sun Pharma Global; Impax Labs |
- Treatment of major depressive disorder;
- Treatment of diabetic peripheral neuropathic pain;
- Treatment of generalised anxiety disorder;
- Duloxetine Mylan is indicated in adults.
Duloxetine Lilly is indicated in adults for:
- Treatment of major depressive disorder
- Treatment of diabetic peripheral neuropathic pain
- Treatment of generalised anxiety disorder
Duloxetine Lilly is indicated in adults.
Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Cymbalta is indicated in adults.
Treatment of diabetic peripheral neuropathic pain.
Ariclaim is indicated in adults.
Treatment of diabetic peripheral neuropathic pain in adults.
Treatment of chronic pain, Treatment of diabetic neuropathic pain, Treatment of generalised anxiety disorder, Treatment of major depressive disorder, Treatment of stress urinary incontinence
Antidepressive Agents
Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)
Analgesics
Compounds capable of relieving pain without the loss of CONSCIOUSNESS. (See all compounds classified as Analgesics.)
Serotonin and Noradrenaline Reuptake Inhibitors
Drugs that selectively block or suppress the plasma membrane transport of SEROTONIN and NORADRENALINE into axon terminals and are used as ANTIDEPRESSIVE AGENTS. (See all compounds classified as Serotonin and Noradrenaline Reuptake Inhibitors.)
Dopamine Agents
Any drugs that are used for their effects on dopamine receptors, on the life cycle of dopamine, or on the survival of dopaminergic neurons. (See all compounds classified as Dopamine Agents.)
N06AX21
N06AX21
N06AX21
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API SUPPLIERS
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USDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-15
Pay. Date : 2022-03-08
DMF Number : 36834
Submission : 2022-03-16
Status : Active
Type : II
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-23
Pay. Date : 2013-03-06
DMF Number : 24939
Submission : 2011-05-06
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-08
DMF Number : 21827
Submission : 2008-07-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-17
Pay. Date : 2020-11-10
DMF Number : 20996
Submission : 2007-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19974
Submission : 2006-11-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21485
Submission : 2008-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-23
Pay. Date : 2018-02-09
DMF Number : 21478
Submission : 2008-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21385
Submission : 2008-02-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19631
Submission : 2006-07-25
Status : Inactive
Type : II
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Drugs in Development
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USFDA APPLICATION NUMBER - 21427
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 30MG BASE
USFDA APPLICATION NUMBER - 21427
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 60MG BASE
USFDA APPLICATION NUMBER - 21427
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ABOUT THIS PAGE
48
PharmaCompass offers a list of Duloxetine 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 Duloxetine manufacturer or Duloxetine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Duloxetine manufacturer or Duloxetine supplier.
PharmaCompass also assists you with knowing the Duloxetine API Price utilized in the formulation of products. Duloxetine API Price is not always fixed or binding as the Duloxetine Price is obtained through a variety of data sources. The Duloxetine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Duloxetine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Duloxetine HCl, including repackagers and relabelers. The FDA regulates Duloxetine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Duloxetine HCl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Duloxetine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Duloxetine HCl supplier is an individual or a company that provides Duloxetine HCl active pharmaceutical ingredient (API) or Duloxetine HCl finished formulations upon request. The Duloxetine HCl suppliers may include Duloxetine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Duloxetine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Duloxetine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Duloxetine HCl active pharmaceutical ingredient (API) in detail. Different forms of Duloxetine HCl DMFs exist exist since differing nations have different regulations, such as Duloxetine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Duloxetine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Duloxetine HCl USDMF includes data on Duloxetine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Duloxetine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Duloxetine HCl 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 Duloxetine HCl Drug Master File in Japan (Duloxetine HCl JDMF) empowers Duloxetine HCl 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 Duloxetine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Duloxetine HCl 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 Duloxetine HCl 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 Duloxetine HCl Drug Master File in Korea (Duloxetine HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Duloxetine HCl. The MFDS reviews the Duloxetine HCl KDMF as part of the drug registration process and uses the information provided in the Duloxetine HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Duloxetine HCl 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 Duloxetine HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Duloxetine HCl suppliers with KDMF on PharmaCompass.
A Duloxetine HCl CEP of the European Pharmacopoeia monograph is often referred to as a Duloxetine HCl Certificate of Suitability (COS). The purpose of a Duloxetine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Duloxetine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Duloxetine HCl to their clients by showing that a Duloxetine HCl CEP has been issued for it. The manufacturer submits a Duloxetine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Duloxetine HCl CEP holder for the record. Additionally, the data presented in the Duloxetine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Duloxetine HCl DMF.
A Duloxetine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Duloxetine HCl CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Duloxetine HCl suppliers with CEP (COS) on PharmaCompass.
A Duloxetine HCl written confirmation (Duloxetine HCl WC) is an official document issued by a regulatory agency to a Duloxetine HCl manufacturer, verifying that the manufacturing facility of a Duloxetine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Duloxetine HCl APIs or Duloxetine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Duloxetine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Duloxetine HCl 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 Duloxetine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Duloxetine HCl 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 Duloxetine HCl as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Duloxetine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Duloxetine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Duloxetine HCl suppliers with NDC on PharmaCompass.
Duloxetine HCl Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Duloxetine HCl GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Duloxetine HCl GMP manufacturer or Duloxetine HCl GMP API supplier for your needs.
A Duloxetine HCl CoA (Certificate of Analysis) is a formal document that attests to Duloxetine HCl's compliance with Duloxetine HCl specifications and serves as a tool for batch-level quality control.
Duloxetine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Duloxetine HCl CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Duloxetine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Duloxetine HCl EP), Duloxetine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Duloxetine HCl USP).
