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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.)
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API SUPPLIERS
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USDMF
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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
Status : Valid
Issue Date : 2024-12-19
Type : Chemical
Substance Number : 2594
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Duloxetine Hydrochloride, Milled, Micronised
Certificate Number : CEP 2012-319 - Rev 01
Status : Valid
Issue Date : 2024-06-21
Type : Chemical
Substance Number : 2594
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Certificate Number : R1-CEP 2012-217 - Rev 01
Status : Valid
Issue Date : 2022-09-21
Type : Chemical
Substance Number : 2594
Certificate Number : R1-CEP 2013-016 - Rev 02
Status : Valid
Issue Date : 2021-07-26
Type : Chemical
Substance Number : 2594
Certificate Number : R1-CEP 2014-239 - Rev 00
Status : Valid
Issue Date : 2020-08-28
Type : Chemical
Substance Number : 2594
Certificate Number : R1-CEP 2015-166 - Rev 00
Status : Valid
Issue Date : 2021-10-22
Type : Chemical
Substance Number : 2594
Certificate Number : R0-CEP 2013-197 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2014-12-01
Type : Chemical
Substance Number : 2594
Certificate Number : R1-CEP 2014-297 - Rev 00
Status : Valid
Issue Date : 2021-08-05
Type : Chemical
Substance Number : 2594
Certificate Number : R1-CEP 2013-340 - Rev 00
Status : Valid
Issue Date : 2020-11-03
Type : Chemical
Substance Number : 2594
Certificate Number : R0-CEP 2015-130 - Rev 01
Status : Expired
Issue Date : 2019-02-12
Type : Chemical
Substance Number : 2594
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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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 : 2020-01-27
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Registration Number : 229MF10017
Registrant's Address : No. 61, Ln. 309, Haihu N. Rd. , Luzhu Dist. , Taoyuan City 33856, Taiwan
Initial Date of Registration : 2017-01-25
Latest Date of Registration : 2017-01-25
Duloxetine Hydrochloride "Teva"
Registration Number : 302MF10024
Registrant's Address : Neot-Hovav Eco-Industrial Park, Be'er Sheva 8412316, Israel
Initial Date of Registration : 2020-02-06
Latest Date of Registration : 2020-02-06
Duloxetine hydrochloride (for manufacturing purposes only)
Registration Number : 305MF10047
Registrant's Address : 55 Yokohoonji, Kamiichi-cho, Nakaniikawa-gun, Toyama Prefecture
Initial Date of Registration : 2023-04-05
Latest Date of Registration : 2023-04-05
Registration Number : 301MF10085
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2019-10-25
Latest Date of Registration : 2019-11-27
Registration Number : 302MF10022
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...
Initial Date of Registration : 2020-02-06
Latest Date of Registration : 2020-02-06
Registration Number : 301MF10094
Registrant's Address : 500, Sinnae-ro, Geumwang-eup, Eumseong-gun, Chungcheongbuk-do, Korea
Initial Date of Registration : 2019-11-15
Latest Date of Registration : 2019-11-15
Registration Number : 302MF10025
Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 4...
Initial Date of Registration : 2020-02-06
Latest Date of Registration : 2020-11-18
Registration Number : 229MF10088
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2017-04-26
Latest Date of Registration : 2022-11-16
Registration Number : 302MF10002
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2020-01-07
Latest Date of Registration : 2025-01-28
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Duloxetine Hydrochloride Ph. Eur
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0082
Address of the Firm : Karakhadi, Plot No. 842-843, At - Karakhdi, Tal. - Padra, Dist -Vadodara, Gujara...
Duloxetine Hydrochloride Ph.Eur
Date of Issue : 2025-07-11
Valid Till : 2028-06-25
Written Confirmation Number : WC-0023
Address of the Firm : Sy. No\'s. 52,53,58,59,61 to 78, 127 & 128, Pydibhimavaram Village & Sy. No\'s. ...
Duloxetine Hydrochloride Ph.Eur./USP
Date of Issue : 2025-07-11
Valid Till : 2028-07-02
Written Confirmation Number : WC-0097
Address of the Firm : Block No. 251/B, 252/B, 253, 254, 255, 256, 258/B, 276, 277, 278/P, 279, 280, 28...
Duloxetine Hydrochloride IH/USP/EP
Date of Issue : 2025-09-19
Valid Till : 2028-07-03
Written Confirmation Number : WC-0040
Address of the Firm : Unit-l, Sy. No. 213, 214 & 255, Bonthapally (Village),Gummadidala (Mandal), Sang...
Date of Issue : 2025-06-19
Valid Till : 2028-07-02
Written Confirmation Number : WC-0091
Address of the Firm : P.O. Sejavta, District -Ratlam, (M.P.)-457001, India
Duloxetine Hydrochloride USP/EP
Date of Issue : 2025-11-12
Valid Till : 2028-11-10
Written Confirmation Number : WC-0079
Address of the Firm : Plot No. - 2209, G.I.D.C., Sarigam - 396 155, Dist - Valsad, Gujarat, India
Date of Issue : 2025-10-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0087
Address of the Firm : Plot No.1 to 5, 31 to 35 & 48 to 51, 26 & Kl201, Village Lakhmapur, Taluka Dindo...
Duloxetine Hydrochloride USP/Ph. Eur
Date of Issue : 2025-07-07
Valid Till : 2028-07-14
Written Confirmation Number : WC-0021
Address of the Firm : Sy. Nos, 317,320,321,322,323,604 & 605, Pincode-502329, Rudraram (Village), Pata...
Duloxetine Hydrochloride USP/EP
Date of Issue : 2025-08-08
Valid Till : 2028-07-25
Written Confirmation Number : WC-0027
Address of the Firm : Unit-ll, Sy. No. 14, Gaddapotharam Village, IDA, Khazipally, Jinnaram Mandal, Sa...
Date of Issue : 2025-09-29
Valid Till : 2028-09-28
Written Confirmation Number : WC-0118
Address of the Firm : Unit-1, Survey No. 10, Gaddapotharam (V), Kazipally Industrial Area, Jinnaram (M...
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Evonik Health Care is the innovation hub for leading life science companies
NDC Package Code : 62128-0386
Start Marketing Date : 2004-08-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
NDC Package Code : 71495-0003
Start Marketing Date : 2022-02-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49587-111
Start Marketing Date : 2016-06-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65977-0035
Start Marketing Date : 2004-08-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65372-1163
Start Marketing Date : 2012-02-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 14501-0005
Start Marketing Date : 2010-03-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51927-0059
Start Marketing Date : 2021-03-08
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 69056-001
Start Marketing Date : 2024-05-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49711-1507
Start Marketing Date : 2009-10-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis, part of the Servier Group, manufactures products at three EMA-, FDA-, ANVISA-, PMDA-, and KFDA-certified sites in Hungary. It sells branded products in 18 countries and reach...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
About the Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-growth therapeutic ar...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
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SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products with a focus on rapid development and cost-effective production. Its fully equipped research labs, pilot...
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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
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ABOUT THIS PAGE
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PharmaCompass offers a list of Duloxetine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Duloxetine Hydrochloride manufacturer or Duloxetine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Duloxetine Hydrochloride manufacturer or Duloxetine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Duloxetine Hydrochloride API Price utilized in the formulation of products. Duloxetine Hydrochloride API Price is not always fixed or binding as the Duloxetine Hydrochloride Price is obtained through a variety of data sources. The Duloxetine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH], including repackagers and relabelers. The FDA regulates DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] supplier is an individual or a company that provides DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] active pharmaceutical ingredient (API) or DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] finished formulations upon request. The DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] suppliers may include DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] API manufacturers, exporters, distributors and traders.
click here to find a list of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] DMF (Drug Master File) is a document detailing the whole manufacturing process of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] active pharmaceutical ingredient (API) in detail. Different forms of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] DMFs exist exist since differing nations have different regulations, such as DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] DMF submitted to regulatory agencies in the US is known as a USDMF. DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] USDMF includes data on DULOXETINE HYDROCHLORIDE [EP MONOGRAPH]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] Drug Master File in Japan (DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] JDMF) empowers DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] JDMF during the approval evaluation for pharmaceutical products. At the time of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] Drug Master File in Korea (DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH]. The MFDS reviews the DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] KDMF as part of the drug registration process and uses the information provided in the DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] KDMF to evaluate the safety and efficacy of the drug.
After submitting a DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] API can apply through the Korea Drug Master File (KDMF).
click here to find a list of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] suppliers with KDMF on PharmaCompass.
A DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] CEP of the European Pharmacopoeia monograph is often referred to as a DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] Certificate of Suitability (COS). The purpose of a DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] to their clients by showing that a DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] CEP has been issued for it. The manufacturer submits a DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] CEP (COS) as part of the market authorization procedure, and it takes on the role of a DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] CEP holder for the record. Additionally, the data presented in the DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] DMF.
A DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] suppliers with CEP (COS) on PharmaCompass.
A DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] written confirmation (DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] WC) is an official document issued by a regulatory agency to a DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] manufacturer, verifying that the manufacturing facility of a DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] APIs or DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] finished pharmaceutical products to another nation, regulatory agencies frequently require a DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] WC (written confirmation) as part of the regulatory process.
click here to find a list of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] suppliers with NDC on PharmaCompass.
DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] GMP manufacturer or DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] GMP API supplier for your needs.
A DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] CoA (Certificate of Analysis) is a formal document that attests to DULOXETINE HYDROCHLORIDE [EP MONOGRAPH]'s compliance with DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] specifications and serves as a tool for batch-level quality control.
DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] CoA mostly includes findings from lab analyses of a specific batch. For each DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] 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 HYDROCHLORIDE [EP MONOGRAPH] may be tested according to a variety of international standards, such as European Pharmacopoeia (DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] EP), DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DULOXETINE HYDROCHLORIDE [EP MONOGRAPH] USP).
