Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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
N06AX21
N06AX21
N06AX21
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-859
Start Marketing Date : 2007-02-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Certificate Number : CEP 2023-144 - Rev 00
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2594
Status : Valid
Jai Radhe Sales is your partner for all your sourcing needs.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-15
Pay. Date : 2022-03-08
DMF Number : 36834
Submission : 2022-03-16
Status : Active
Type : II
Certificate Number : CEP 2012-319 - Rev 01
Issue Date : 2024-06-21
Type : Chemical
Substance Number : 2594
Status : Valid
Registration Number : 302MF10013
Registrant's Address : Cesar Martinell i Brunet 12A, Poligono Rubi Sur, Rubi (Barcelona), Spain
Initial Date of Registration : 2020-01-27
Latest Date of Registration :
NDC Package Code : 71495-0003
Start Marketing Date : 2022-02-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Saehan Pharmaceutical Co., Ltd.
Registration Date : 2015-07-27
Registration Number : Su4098-3-ND
Manufacturer Name : Moehs Cantabra SL_x000D_
Manufacturer Address : Poligono Industrial Requejada, 39313, Polanco, Cantabria, Spain
| Available Reg Filing : ASMF |
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
CAS Number : 5034-06-0
End Use API : Duloxetine Hydrochloride
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
(S)-3-Methyl amino-1-(2-thienyl)-1-propanol
CAS Number : 116539-55-0
End Use API : Duloxetine Hydrochloride
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
(S)-N-Methyl-3-hydroxy-3-(2-thienyl)propanamine
CAS Number : 116539-55-0
End Use API : Duloxetine Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
(S)-N,N-Dimethyl-3-hydroxy-3-(2-thienyl)propanami...
CAS Number : 132335-44-5
End Use API : Duloxetine Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
RS-N,N-Dimethyl-3-hydroxy-3-(2-thienyl)-1-propanam...
CAS Number : 13636-02-7
End Use API : Duloxetine Hydrochloride
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
S-(+)-N,N- Dimethyl-3-(1-Naphthalenyloxy)-3-(2-thi...
CAS Number : 132335-44-5
End Use API : Duloxetine Hydrochloride
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
RS-N,N- Dimethyl-3-(1-Naphthalenyloxy)-3-(2-thieny...
CAS Number : 116817-84-6
End Use API : Duloxetine Hydrochloride
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
3-Dimethyl amino-1-(2-thienyl)-1-propanone HCl
CAS Number : 5424-47-5
End Use API : Duloxetine Hydrochloride
About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...
RS-N,N-Dimethyl-3-hydroxy-3-(2-thienyl)-1-propanam...
CAS Number : 13636-02-7
End Use API : Duloxetine Hydrochloride
About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...
S(-)-N,N-Dimethyl-3-hydroxy-3-(2-thienyl)-1-propan...
CAS Number : 132335-44-5
End Use API : Duloxetine Hydrochloride
About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Duloxetine Zentiva
Dosage Form : Capsules
Dosage Strength : 30mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Duloxetine Zentiva
Dosage Form : Kaps
Dosage Strength : 60mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Duloxetine Zentiva
Dosage Form : Capsules
Dosage Strength : 60mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Duloxetine Zentiva
Dosage Form : Kaps
Dosage Strength : 60mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Duloxetine Orion
Dosage Form : GASTRO-RESISTANT CAPSULE, HARD
Dosage Strength : 30 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Duloxetine Orion
Dosage Form : GASTRO-RESISTANT CAPSULE, HARD
Dosage Strength : 60 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Delayed Release Pellet
Dosage Strength : 17%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Delayed Release Pellet
Dosage Strength : 20%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Delayed Release Pellet
Dosage Strength : 20%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 20MG BASE
Packaging :
Approval Date : 2014-06-11
Application Number : 203088
Regulatory Info : RX
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : No
TE Code : AB
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2014-06-11
Application Number : 203088
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 30MG BASE
Approval Date : 2014-06-11
Application Number : 203088
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 60MG BASE
Approval Date : 2014-06-11
Application Number : 203088
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 40MG BASE
Approval Date : 2018-05-18
Application Number : 203088
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 60MG BASE
Approval Date : 2013-12-17
Application Number : 90776
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2014-06-09
Application Number : 202949
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2016-08-03
Application Number : 204343
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 60MG BASE
Approval Date : 2013-12-11
Application Number : 90723
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 60MG BASE
Approval Date : 2017-05-18
Application Number : 206653
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DULOXETINE HYDROCHLORIDE
Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2019-04-17
Application Number : 210599
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Delayed Release Pellet
Dosage Strength : 17%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Packaging :
Regulatory Info :
Dosage : Delayed Release Pellet
Dosage Strength : 17%
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Delayed Release Pellet
Dosage Strength : 20%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Packaging :
Regulatory Info :
Dosage : Delayed Release Pellet
Dosage Strength : 20%
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Delayed Release Pellet
Dosage Strength : 20%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Packaging :
Regulatory Info :
Dosage : Delayed Release Pellet
Dosage Strength : 20%
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Hard Gastro-resistant ...
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Hard Gastro-resistant ...
Dosage Strength : 30MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Hard Gastro-resistant ...
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Hard Gastro-resistant ...
Dosage Strength : 60MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Packaging :
Regulatory Info :
Dosage : Hard Capsule
Dosage Strength : 30MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Packaging :
Regulatory Info :
Dosage : Hard Capsule
Dosage Strength : 60MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info : Commercialized In: UK (2018); ...
Registration Country : India
Brand Name :
Dosage Form : Gastro Resistant Capsu...
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Commercialized In: UK (2018); ...
Registration Country : India
Packaging :
Regulatory Info : Commercialized In: UK (2018); ...
Dosage : Gastro Resistant Capsu...
Dosage Strength : 30MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Iran
Brand Name : DULOXETINE 20
Dosage Form : Capsule
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 20MG
Brand Name : DULOXETINE 20
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Gastro Resistant Table...
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE
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
Related Excipient Companies
Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Coating Systems & Additives
Controlled & Modified Release
Solubilizers
Disintegrants & Superdisintegrants
Direct Compression
Thickeners and Stabilizers
Granulation
Taste Masking
Topical
Chewable & Orodispersible Aids
Parenteral
Lubricants & Glidants
Film Formers & Plasticizers
Co-Processed Excipients
Empty Capsules
Emulsifying Agents
API Stability Enhancers
Rheology Modifiers
Coloring Agents
Surfactant & Foaming Agents
Vegetarian Capsules
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
BioAnalytical Methods
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Analytical Methods
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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Duloxetine, including repackagers and relabelers. The FDA regulates Duloxetine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Duloxetine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Duloxetine supplier is an individual or a company that provides Duloxetine active pharmaceutical ingredient (API) or Duloxetine finished formulations upon request. The Duloxetine suppliers may include Duloxetine API manufacturers, exporters, distributors and traders.
click here to find a list of Duloxetine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Duloxetine DMF (Drug Master File) is a document detailing the whole manufacturing process of Duloxetine active pharmaceutical ingredient (API) in detail. Different forms of Duloxetine DMFs exist exist since differing nations have different regulations, such as Duloxetine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Duloxetine DMF submitted to regulatory agencies in the US is known as a USDMF. Duloxetine USDMF includes data on Duloxetine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Duloxetine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Duloxetine 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 Drug Master File in Japan (Duloxetine JDMF) empowers Duloxetine 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Duloxetine 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 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 Drug Master File in Korea (Duloxetine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Duloxetine. The MFDS reviews the Duloxetine KDMF as part of the drug registration process and uses the information provided in the Duloxetine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Duloxetine 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Duloxetine suppliers with KDMF on PharmaCompass.
A Duloxetine CEP of the European Pharmacopoeia monograph is often referred to as a Duloxetine Certificate of Suitability (COS). The purpose of a Duloxetine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Duloxetine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Duloxetine to their clients by showing that a Duloxetine CEP has been issued for it. The manufacturer submits a Duloxetine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Duloxetine CEP holder for the record. Additionally, the data presented in the Duloxetine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Duloxetine DMF.
A Duloxetine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Duloxetine 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 suppliers with CEP (COS) on PharmaCompass.
A Duloxetine written confirmation (Duloxetine WC) is an official document issued by a regulatory agency to a Duloxetine manufacturer, verifying that the manufacturing facility of a Duloxetine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Duloxetine APIs or Duloxetine finished pharmaceutical products to another nation, regulatory agencies frequently require a Duloxetine WC (written confirmation) as part of the regulatory process.
click here to find a list of Duloxetine 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Duloxetine 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Duloxetine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Duloxetine suppliers with NDC on PharmaCompass.
Duloxetine 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 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 GMP manufacturer or Duloxetine GMP API supplier for your needs.
A Duloxetine CoA (Certificate of Analysis) is a formal document that attests to Duloxetine's compliance with Duloxetine specifications and serves as a tool for batch-level quality control.
Duloxetine CoA mostly includes findings from lab analyses of a specific batch. For each Duloxetine 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Duloxetine EP), Duloxetine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Duloxetine USP).
