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1. 5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide
2. Flomax
3. Ly 253352
4. Ly-253352
5. Tamsulosin
6. Ym 617
7. Ym-617
1. 106463-17-6
2. Flomax
3. Tamsulosin Hcl
4. Omnic
5. Pradif
6. Harnal
7. Urolosin
8. Secotex
9. Josir
10. Alna
11. Omic
12. Omix
13. Ym617
14. Ly253351
15. Amsulosin Hydrochloride
16. Tamsulosin (hydrochloride)
17. (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Hydrochloride
18. R-(-)-ym-12617
19. Ym 617
20. Ym-12617-1
21. Ym-617
22. Ly-253351
23. Chebi:9399
24. (-)-(r)-5-(2-((2-(o-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Monohydrochloride
25. 11sv1951mr
26. 5-[(2r)-2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride
27. 5-[(2r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxybenzenesulfonamide;hydrochloride
28. 5-[(r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]]-2-methoxybenzenesulfonamide Hydrochloride
29. R-(-)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Hydrochloride
30. Expros
31. Flomax (tn)
32. Dsstox_cid_26628
33. Dsstox_rid_81777
34. Dsstox_gsid_46628
35. 128332-25-2
36. Benzenesulfonamide, 5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxy-, Monohydrochloride, (r)-
37. (r)-5-(2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2-methoxybenzenesulfonamide Hydrochloride
38. (-)-(r)-5-(2-((2-(o-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzene Sulfonamide Monohydrochloride
39. Cas-106463-17-6
40. Tamsulosine Hydrochloride
41. Ncgc00167442-01
42. Mfcd00922997
43. (r)-tamsulosin Hydrochloride
44. Unii-11sv1951mr
45. Tamsulosin.hcl
46. Harnalidge Ocas
47. Flomax Mr
48. Alnaocas
49. 5-[(2r)-2-{[2-(2-ethoxyphenoxy)ethyl]amino}propyl]-2-methoxybenzenesulfonamide Hydrochloride
50. Flomax Hydrochloride
51. Harnal (tn)
52. Tamsulosin Hydrochloride [usan:usp:jan]
53. Tamsulosina Hydrochloride
54. Tamsulosinum Hydrochloride
55. (-)-ly 253352
56. Schembl23428
57. Tamsulosin Hydrochloride,(s)
58. Mls003899197
59. Racemic Tamsulosin Hydrochloride
60. Chembl1200914
61. Dtxsid2046628
62. Hy-b0661a
63. 5-[(2rs)-2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride (tamsulosin Racemate Hydrochloride)
64. Tox21_112446
65. Eu-617
66. S4729
67. (r)-tamsulosin Hydrochloride- Bio-x
68. Tamsulosin Hydrochloride (jp17/usp)
69. Tamsulosin Hydrochloride [jan]
70. Akos015895342
71. Akos015995287
72. Tox21_112446_1
73. Bs-1019
74. Ccg-269178
75. Tamsulosin Hydrochloride [usan]
76. (-)-ly253352
77. Tamsulosin Hydrochloride [mart.]
78. Tamsulosin Hydrochloride [vandf]
79. Ncgc00167442-03
80. Tamsulosin Hydrochloride [usp-rs]
81. Tamsulosin Hydrochloride [who-dd]
82. Bt164440
83. Smr002543366
84. Bcp0726000042
85. Tamsulosin Hydrochloride, >=98% (hplc)
86. T2749
87. Y-617
88. Tamsulosin Hydrochloride [orange Book]
89. A14936
90. D01024
91. Jalyn Component Tamsulosin Hydrochloride
92. Tamsulosin Hydrochloride [ep Monograph]
93. Tamsulosin Hydrochloride [usp Impurity]
94. Tamsulosin Hydrochloride [usp Monograph]
95. 463t176
96. A801444
97. Tamsulosin Hydrochloride Component Of Jalyn
98. Q-201777
99. (r)-(-)-ym12617;ly253351
100. (r)-5-(2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2
101. Q27108379
102. Tamsulosin Hydrochloride, British Pharmacopoeia (bp) Reference Standard
103. Tamsulosin Hydrochloride, European Pharmacopoeia (ep) Reference Standard
104. (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Hcl
105. 5-((2r)-2-(2-(2-ethoxyphenoxy)ethylamino)propyl)-2-methoxybenzene-sulfonamide Hcl
106. 5-[(r)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]]-2-methoxybenzenesulfonamidehydrochloride
107. Tamsulosin Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
108. Tamsulosin Hydrochloride, United States Pharmacopeia (usp) Reference Standard
109. (r)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide Monohydrochloride
110. 5-[(2r)-2-[[2-(-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride;tamsulosin Hcl
Molecular Weight | 445.0 g/mol |
---|---|
Molecular Formula | C20H29ClN2O5S |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 11 |
Exact Mass | 444.1485709 g/mol |
Monoisotopic Mass | 444.1485709 g/mol |
Topological Polar Surface Area | 108 Ų |
Heavy Atom Count | 29 |
Formal Charge | 0 |
Complexity | 539 |
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 | Flomax |
PubMed Health | Tamsulosin (By mouth) |
Drug Classes | Benign Prostatic Hypertrophy Agent |
Drug Label | Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white... |
Active Ingredient | Tamsulosin hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | 0.4mg |
Market Status | Prescription |
Company | Boehringer Ingelheim |
2 of 4 | |
---|---|
Drug Name | Tamsulosin hydrochloride |
Drug Label | Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white... |
Active Ingredient | Tamsulosin hydrochloride |
Dosage Form | Capsule |
Route | oral; Oral |
Strength | 0.4mg |
Market Status | Tentative Approval; Prescription |
Company | Synthon Pharms; Anchen Pharms; Wockhardt; Ranbaxy; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Teva Pharms; Zydus Pharms Usa; Mylan; Impax Labs |
3 of 4 | |
---|---|
Drug Name | Flomax |
PubMed Health | Tamsulosin (By mouth) |
Drug Classes | Benign Prostatic Hypertrophy Agent |
Drug Label | Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white... |
Active Ingredient | Tamsulosin hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | 0.4mg |
Market Status | Prescription |
Company | Boehringer Ingelheim |
4 of 4 | |
---|---|
Drug Name | Tamsulosin hydrochloride |
Drug Label | Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white... |
Active Ingredient | Tamsulosin hydrochloride |
Dosage Form | Capsule |
Route | oral; Oral |
Strength | 0.4mg |
Market Status | Tentative Approval; Prescription |
Company | Synthon Pharms; Anchen Pharms; Wockhardt; Ranbaxy; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Teva Pharms; Zydus Pharms Usa; Mylan; Impax Labs |
Urological Agents
Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)
Adrenergic alpha-1 Receptor Antagonists
Drugs that bind to and block the activation of ADRENERGIC ALPHA-1 RECEPTORS. (See all compounds classified as Adrenergic alpha-1 Receptor Antagonists.)
Registration Number : 225MF10100
Registrant's Address : To(´) utca 1-5. , 1045 Budapest, Hungary
Initial Date of Registration : 2013-05-09
Latest Date of Registration : --
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Registration Number : 219MF10365
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2007-12-13
Latest Date of Registration : --
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.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-23
Pay. Date : 2015-08-27
DMF Number : 28648
Submission : 2014-09-15
Status : Active
Type : II
Certificate Number : R1-CEP 2012-309 - Rev 02
Issue Date : 2022-12-15
Type : Chemical
Substance Number : 2131
Status : Valid
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm :
NDC Package Code : 17511-118
Start Marketing Date : 2020-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : CN, RU |
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23145
Submission : 2009-09-30
Status : Active
Type : II
NDC Package Code : 53296-0073
Start Marketing Date : 2010-05-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Dutasteride; Tamsulosin hydrochloride
Brand Name : Dutasterid Tamsulosin Zentiva
Dosage Form : Caps
Dosage Strength : 0.5/0.4mg
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
Dutasteride; Tamsulosin hydrochloride
Brand Name : Dutasterid Tamsulosin Zentiva
Dosage Form : Caps
Dosage Strength : 0.5/0.4mg
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
Dutasteride; Tamsulosin hydrochloride
Brand Name : Dutasteride Tamsulosin Zentiva
Dosage Form : Caps
Dosage Strength : 0.5/0.4mg
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.
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Registration Country : Switzerland
Brand Name : Tamsulosin retard Zentiva
Dosage Form : Ret Caps
Dosage Strength : 0.4mg
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.
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Registration Country : Switzerland
Brand Name : Tamsulosin retard Zentiva
Dosage Form : Ret Caps
Dosage Strength : 0.4mg
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 : Tamsulosin retard Zentiva
Dosage Form : Ret Caps
Dosage Strength : 0.4mg
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Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : TAMSULOSIN THINKS
Dosage Form : Hard Capsules With Modified Release
Dosage Strength : 0.4 mg
Packaging : 20 UNITS 0.4 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : TAMSULOSIN THINKS
Dosage Form : Modified Release Hard Capsules
Dosage Strength : 0.4 mg
Packaging : 30 UNITS 0.4 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : Tamsulosin Sandoz eco
Dosage Form : Ret Caps
Dosage Strength : 0.4mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Spain
Brand Name : Normon Tamsulosin 0.4Mg 30 Comp Liberac Protracted (Pvc/Pvdc/Al) Efg
Dosage Form : Modified Release Tablet
Dosage Strength : 0.4 Mg/modified release tablet
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
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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 : Capsule
Dosage Strength : 0.4MG
Packaging :
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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 :
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Dosage : Capsule
Dosage Strength : 0.4MG
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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
Solifenacin Succinate; Tamsulosin
Brand Name :
Dosage Form : Tablet
Dosage Strength : 6MG; 0.4MG
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 :
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Solifenacin Succinate; Tamsulosin
Dosage : Tablet
Dosage Strength : 6MG; 0.4MG
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 : Extended Release Pelle...
Dosage Strength : 0.12%
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 :
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Dosage : Extended Release Pelle...
Dosage Strength : 0.12%
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 : Extended Release Pelle...
Dosage Strength : 0.2%
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 : Extended Release Pelle...
Dosage Strength : 0.2%
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Regulatory Info :
Registration Country : Latvia
Dutasteride; Tamsulosin Hydrochloride
Brand Name : Dutasteride/Tamsulosin...
Dosage Form : Hard Capsule
Dosage Strength : 0.5MG; 0.4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Latvia
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Packaging :
Regulatory Info :
Dutasteride; Tamsulosin Hydrochloride
Dosage : Hard Capsule
Dosage Strength : 0.5MG; 0.4MG
Brand Name : Dutasteride/Tamsulosin...
Approval Date :
Application Number :
Registration Country : Latvia
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Controlled Release Tab...
Dosage Strength : 0.4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : Controlled Release Tab...
Dosage Strength : 0.4MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-I...
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 0.4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-I...
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info : DMF Available|FDF Compliance-I...
Dosage : DC Granules
Dosage Strength : 0.4MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : SR Pellets/ Micro Pell...
Dosage Strength : 0.125%, 0.13%, 0.16%, ...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : SR Pellets/ Micro Pell...
Dosage Strength : 0.125%, 0.13%, 0.16%, ...
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Pellets
Dosage Strength : 0.16%W/W
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Pellets
Dosage Strength : 0.16%W/W
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : URILOSIN-D
Dosage Form : Tablet
Dosage Strength : 0.4MG; 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 0.4MG; 0.5MG
Brand Name : URILOSIN-D
Approval Date :
Application Number :
Registration Country : India
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ABOUT THIS PAGE
A Tamsulosin HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tamsulosin HCl, including repackagers and relabelers. The FDA regulates Tamsulosin HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tamsulosin 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 Tamsulosin HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tamsulosin HCl supplier is an individual or a company that provides Tamsulosin HCl active pharmaceutical ingredient (API) or Tamsulosin HCl finished formulations upon request. The Tamsulosin HCl suppliers may include Tamsulosin HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Tamsulosin HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tamsulosin HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Tamsulosin HCl active pharmaceutical ingredient (API) in detail. Different forms of Tamsulosin HCl DMFs exist exist since differing nations have different regulations, such as Tamsulosin HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tamsulosin HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Tamsulosin HCl USDMF includes data on Tamsulosin HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tamsulosin HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tamsulosin 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 Tamsulosin HCl Drug Master File in Japan (Tamsulosin HCl JDMF) empowers Tamsulosin 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 Tamsulosin HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Tamsulosin 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 Tamsulosin 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 Tamsulosin HCl Drug Master File in Korea (Tamsulosin HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tamsulosin HCl. The MFDS reviews the Tamsulosin HCl KDMF as part of the drug registration process and uses the information provided in the Tamsulosin HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tamsulosin 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 Tamsulosin HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tamsulosin HCl suppliers with KDMF on PharmaCompass.
A Tamsulosin HCl CEP of the European Pharmacopoeia monograph is often referred to as a Tamsulosin HCl Certificate of Suitability (COS). The purpose of a Tamsulosin HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tamsulosin HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tamsulosin HCl to their clients by showing that a Tamsulosin HCl CEP has been issued for it. The manufacturer submits a Tamsulosin HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tamsulosin HCl CEP holder for the record. Additionally, the data presented in the Tamsulosin HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tamsulosin HCl DMF.
A Tamsulosin HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tamsulosin 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 Tamsulosin HCl suppliers with CEP (COS) on PharmaCompass.
A Tamsulosin HCl written confirmation (Tamsulosin HCl WC) is an official document issued by a regulatory agency to a Tamsulosin HCl manufacturer, verifying that the manufacturing facility of a Tamsulosin HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tamsulosin HCl APIs or Tamsulosin HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Tamsulosin HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Tamsulosin 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 Tamsulosin HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tamsulosin 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 Tamsulosin 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 Tamsulosin HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tamsulosin HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tamsulosin HCl suppliers with NDC on PharmaCompass.
Tamsulosin 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 Tamsulosin 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 Tamsulosin HCl GMP manufacturer or Tamsulosin HCl GMP API supplier for your needs.
A Tamsulosin HCl CoA (Certificate of Analysis) is a formal document that attests to Tamsulosin HCl's compliance with Tamsulosin HCl specifications and serves as a tool for batch-level quality control.
Tamsulosin HCl CoA mostly includes findings from lab analyses of a specific batch. For each Tamsulosin 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.
Tamsulosin HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Tamsulosin HCl EP), Tamsulosin HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tamsulosin HCl USP).
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