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1. 1-(3-hydroxypropyl)-5-(2-(2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethylamino)propyl)indoline-7-carboxamide
2. Kmd 3213
3. Kmd-3213
4. Rapaflo
1. 160970-54-7
2. Rapaflo
3. Urief
4. Silodyx
5. Urorec
6. Kmd-3213
7. Kmd 3213
8. Rapilif
9. Silodal
10. Kad 3213
11. Kad-3213
12. Kso-0400
13. Cuz39luy82
14. Chembl24778
15. 1-(3-hydroxypropyl)-5-[(2r)-2-[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethylamino]propyl]-2,3-dihydroindole-7-carboxamide
16. 2,3-dihydro-1-(3-hydroxypropyl)-5-[(2r)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1h-indole-7-carboxamide
17. (-)-1-(3-hydroxypropyl)-5-[(2r)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-di-hydro-1h-indole-7-carboxamide
18. Rapflo
19. Silodosin [inn]
20. ( C)-1-(3-hydroxypropyl)-5-[(2r)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-di-hydro-1h-indole-7-carboxamide
21. (-)-1-(3-hydroxypropyl)-5-((2r)-2-((2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethyl)amino)propyl)-2,3-dihydro-1h-indole-7-carboxamide
22. 1-(3-hydroxypropyl)-5-[(2r)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1h-indole-7-carboxamide
23. 1h-indole-7-carboxamide, 2,3-dihydro-1-(3-hydroxypropyl)-5-[(2r)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-
24. Silodosin [inn:ban]
25. Unii-cuz39luy82
26. Urief, Rapaflo
27. 2,3-dihydro-1-(3-hydroxypropyl)-5-((2r)-2-((2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethyl)amino)propyl)-1h-indole-7-carboxamide
28. Rapaflo (tn)
29. Silodosin (rapaflo)
30. Urief (tn)
31. Silodosin (r-isomer)
32. Silodosin [jan]
33. Silodosin [mi]
34. Silodosin [vandf]
35. Silodosin (jp17/inn)
36. Silodosin [mart.]
37. Silodosin [who-dd]
38. Gtpl493
39. Silodosin [ema Epar]
40. Mls006010022
41. Schembl136973
42. Silodosin [orange Book]
43. Silodosin, >=98% (hplc)
44. Dtxsid40167045
45. Kmd3213
46. Chebi:135929
47. Hms3715b06
48. Hms3884o21
49. Bcp02143
50. Zinc3806063
51. Bdbm50160154
52. Mfcd00930170
53. S1613
54. Akos005145899
55. Kad 3213;kmd 3213
56. Bs-1011
57. Ccg-221202
58. Cs-0284
59. Db06207
60. Ncgc00345882-03
61. 1-(3-hydroxypropyl)-5-(2-(2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethylamino)propyl)indoline-7-carboxamide
62. Ac-22605
63. Hy-10122
64. Smr004701206
65. Am20090780
66. I1128
67. Sw219765-1
68. D01965
69. 970s649
70. A810210
71. Q411770
72. Sr-01000944157
73. Q-102517
74. Sr-01000944157-1
75. (r)-1-(3-hydroxypropyl)-5-(2-(2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethylamino)propyl)indoline-7-carboxamide
76. (r)-5-[2-[[2-[2-(2,2,2-trifluoro-ethoxy)phenoxy]ethyl]amino]propyl]-1-(3-hydroxypropyl)-2,3-dihydro-1h-indole-7-carboxamide
77. 1-(3-hydroxy-propyl)-5-((r)-2-{2-[2-(2,2,2-trifluoro-ethoxy)-phenoxy]-ethylamino}-propyl)-2,3-dihydro-1h-indole-7-carboxylic Acid Amide
78. 1-(3-hydroxypropyl)-5-[(2r)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]-ethyl}amino)propyl]-2,3-dihydro-1h-indole-7-carboxamide
79. 1-(3-hydroxypropyl)-5-[(2r)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-dihydro-1h-indole-7-carboxamide; 1-(3-hydroxypropyl)-5-[(2r)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1h-indole-7-carboxamide; (-)-1
| Molecular Weight | 495.5 g/mol |
|---|---|
| Molecular Formula | C25H32F3N3O4 |
| XLogP3 | 3.6 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 13 |
| Exact Mass | 495.23449100 g/mol |
| Monoisotopic Mass | 495.23449100 g/mol |
| Topological Polar Surface Area | 97 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 654 |
| 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 | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Rapaflo |
| PubMed Health | Silodosin (By mouth) |
| Drug Classes | Benign Prostatic Hypertrophy Agent |
| Drug Label | RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide... |
| Active Ingredient | Silodosin |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | 8mg; 4mg |
| Market Status | Prescription |
| Company | Watson Labs |
| 2 of 2 | |
|---|---|
| Drug Name | Rapaflo |
| PubMed Health | Silodosin (By mouth) |
| Drug Classes | Benign Prostatic Hypertrophy Agent |
| Drug Label | RAPAFLO is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide... |
| Active Ingredient | Silodosin |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | 8mg; 4mg |
| Market Status | Prescription |
| Company | Watson Labs |
Silodosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). It is not indicated for the treatment of hypertension.
FDA Label
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
Silodosin is an antagonist of 1-adrenoceptors. It has the highest selectivity for the 1A-adrenoceptor subtype, with a 162-fold greater affinity than 1B-adrenoceptor and about a 50-fold greater affinity than for 1D-adrenoceptor. In clinical trials, silodosin improved maximum urinary flow rate, voiding symptoms, and storage symptoms of benign prostatic hyperplasia. Following oral administration, silodosin had a rapid onset of effect in men, with early effects of relieving lower urinary tract symptoms occurring within two to six hours post-dose. Silodosin inhibited the human ether-a-go-go-related gene (HERG) tail current; however, it has weak cardiovascular effects. As with all 1-adrenoceptor antagonists blocking 1-adrenoceptors in the iris dilator muscle, silodosin may cause intraoperative floppy iris syndrome (IFIS), which is characterized by small pupils and iris billowing during cataract surgery in patients taking 1-AR antagonists.
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.)
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.)
G04CA04
G04CA04
G04CA04
G04CA04
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
G - Genito urinary system and sex hormones
G04 - Urologicals
G04C - Drugs used in benign prostatic hypertrophy
G04CA - Alpha-adrenoreceptor antagonists
G04CA04 - Silodosin
Absorption
The absolute bioavailability is approximately 32%. Following oral administration of silodosin 8 mg once daily in healthy male subjects, Cmax was 61.6 27.54 ng/mL and AUC was 373.4 164.94 ng x hr/mL. The Tmax was 2.6 0.90 hours. Silodosin glucuronide or KMD-3213G, the main metabolite of silodosin, has an AUC three- or four fold higher than for the parent compound. A moderate fat or calorie meal reduces Cmax by 18% to 43% and AUC by 4% to 49%, as well as Tmax by about one hour. However, the US prescribing information recommends drug intake with meals to avoid the potential adverse effects associated with high plasma drug concentrations.
Route of Elimination
At 10 days following oral administration of radiolabelled silodosin, about 33.5% of the dose was recovered in urine and 54.9% was recovered in feces.
Volume of Distribution
Silodosin has an apparent volume of distribution of 49.5 L.
Clearance
After intravenous administration, the plasma clearance of silodosin was approximately 10 L/hour.
The main metabolite of silodosin is silodosin glucuronide (KMD-3213G), which is a pharmacologically active metabolite formed by direct glucuronide conjugation mediated by UDP-glucuronosyltransferase 2B7 (UGT2B7). Silodosin glucuronide reaches plasma exposure (AUC) approximately four times greater than that of silodosin. The second major metabolite, KMD-3293, is formed from dehydrogenation catalyzed by alcohol and aldehyde dehydrogenases. KMD-3293 has negligible pharmacological activity and reaches plasma exposures similar to that of silodosin. Silodosin is also metabolized by CYP3A4, which catalyzes the oxidation reaction. Other than glucuronidation, dehydrogenation, and oxidation as its main metabolic pathways, silodosin can also undergo dealkylation (KMD-3289), N-dealkylation, hydroxylation, glucosylation, and sulfate conjugation. Metabolites of silodosin can undergo a series of further metabolic pathways.
The elimination half-life of silodosin is 13.3 8.07 hours. KMD-3213G, the main metabolite of silodosin, has an extended half-life of approximately 24 hours.
The pathogenesis of benign prostatic hyperplasia is not fully understood: it is believed to involve several pathways, including inflammation, apoptosis, and cellular proliferation. Most drug therapies aim to alleviate symptoms of benign prostatic hyperplasia, silodosin included. Lower urinary tract symptoms of benign prostatic hyperplasia are categorized into three main groups: voiding or obstructive (hesitancy, slow stream, intermittency, incomplete emptying), storage or irritative (frequency, urgency, nocturia, urge urinary incontinence), and postmicturition (postvoid dribbling). Prostate contraction is the main contributor to lower urinary tract symptoms of benign prostatic hyperplasia. The smooth muscle tone of the prostate is regulated by 1A-adrenoceptors, which are the most highly expressed subtype of 1adrenoceptors in the human prostate tissue. It has been reported that blockade of 1A-adrenoceptors relieves bladder outlet obstruction. Blockade of 1D-adrenoceptors, another subtype found in prostate tissue, is believed to alleviate storage symptoms due to detrusor overactivity. 1-adrenoceptors are G protein-coupled receptors: upon binding of its natural ligand, norepinephrine and epinephrine, leads to the activation of phospholipase C and downstream signalling molecules, including inositol triphosphate and diacylglycerol. Ultimately, there is an increase in intracellular calcium levels and, consequently, smooth muscle contraction. Silodosin is an antagonist of 1-adrenoceptors, with the highest selectivity for the 1A-adrenoceptor subtype. By blocking the 1A-adrenoceptor signalling pathway, silodosin promotes prostatic and urethral smooth muscle relaxation, thereby improving lower urinary tract symptoms such as voiding. Silodosin also targets afferent nerves in the bladder, relieving bladder overactivity and storage symptoms.
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About the Company : Lewens Labs was established with a vision to transform the pharmaceutical industry, inspired by an award-winning engineering project that reduced the cost of Aceclofenac and receiv...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
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...
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Inabata France, established in 1990 and part of the Inabata Group, acquired Pharmasynthèse in 2006. Today, Inabata-Pharmasynthèse offers sourcing, manufacturing, and development ...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
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...
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical is a wholly owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Located in the Qihe Economic Development Zone, Sh...
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
About the Company : Capital Farma provides integrated pharmaceutical solutions with a focus on high-quality Active Pharmaceutical Ingredients (APIs) sourced from leading European manufacturers. The co...
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Details:
Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Prostatic Hyperplasia.
Lead Product(s): Silodosin,Inapplicable
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 21, 2025

Qianweitai (Silodosin) vs Tamsulosin for Benign Prostatic Hyperplasia
Details : Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Prostatic Hyperplasia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 21, 2025

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Details:
CDSCO has approved Silodosin (selective alpha1A-adrenergic receptor antagonist) + Tadalafil (PDE5 inhibitor), a fixed dose combination for the treatment of benign prostatic hyperplasia.
Lead Product(s): Silodosin,Tadalafil
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 07, 2023

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Lead Product(s) : Silodosin,Tadalafil
Therapeutic Area : Urology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
SUN Pharma Gets CDSCO Nod to Manufacture, Market FDC Silodosin JP Plus Tadalafil
Details : CDSCO has approved Silodosin (selective alpha1A-adrenergic receptor antagonist) + Tadalafil (PDE5 inhibitor), a fixed dose combination for the treatment of benign prostatic hyperplasia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 07, 2023

Details:
Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Hyperplasia-associated with Lower Urinary Tract Symptoms.
Lead Product(s): Silodosin,Inapplicable
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 22, 2022

Details : Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Hyperplasia-associated with Lower Urinary Tract Symptoms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 22, 2022

Details:
Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Ureteral Calculi.
Lead Product(s): Silodosin,Tamsulosin
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 24, 2015

Lead Product(s) : Silodosin,Tamsulosin
Therapeutic Area : Urology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Silodosin Versus Tamsulosin for Treatment of Ureteral Stones
Details : Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Ureteral Calculi.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 24, 2015

Details:
Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Nocturia.
Lead Product(s): Silodosin,Inapplicable
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 08, 2014

Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia
Details : Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Nocturia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 08, 2014

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Details:
Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Hyperplasia.
Lead Product(s): Silodosin,Inapplicable
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 31, 2012

Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia
Details : Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Hyperplasia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 31, 2012

Details:
Tamsulosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Kidney Calculi.
Lead Product(s): Tamsulosin,Silodosin
Therapeutic Area: Nephrology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 22, 2012

Lead Product(s) : Tamsulosin,Silodosin
Therapeutic Area : Nephrology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Tamsulosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Kidney Calculi.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 22, 2012

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Details:
Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Urinary Calculi.
Lead Product(s): Silodosin,Inapplicable
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 27, 2012

A Dose-finding Study of Silodosin in Patients With Urinary Calculi
Details : Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Urinary Calculi.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 27, 2012

Details:
Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Ureteral Calculi.
Lead Product(s): Silodosin,Inapplicable
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 15, 2012

Details : Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Ureteral Calculi.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 15, 2012

Details:
Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Hyperplasia.
Lead Product(s): Silodosin,Inapplicable
Therapeutic Area: Urology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 15, 2010

Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH
Details : Silodosin is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Hyperplasia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 15, 2010

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl methanes...
CAS Number : 160969-03-9
End Use API : Silodosin
About The Company : Lewens Labs was established with a vision to transform the pharmaceutical industry, inspired by an award-winning engineering project that reduced the cost of Ac...
(R)-3-[5-(2-Aminopropyl)-7-cyano-2,3-dihydro-1Hind...
CAS Number : 239463-85-5
End Use API : Silodosin
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical is a wholly owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Located in the Qihe Economic ...
2-[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl methanes...
CAS Number : 160969-03-9
End Use API : Silodosin
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical is a wholly owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Located in the Qihe Economic ...
5-[(2R)-2-Aminopropyl]-1-[3-(benzoyloxy)propyl]-2,...
CAS Number : 239463-85-5
End Use API : Silodosin
About The Company : Sichuan Qingmu Pharmaceutical is an innovation-driven company specializing in generic APIs, advanced intermediates, and CDMO/CMO services for small-molecule dru...
1-[3-(Benzoyloxy)propyl]-2,3-dihydro-5-(2-nitropro...
CAS Number : 350797-56-7
End Use API : Silodosin
About The Company : Indian Drugs And Chemicals supplies quality products using modern technologies, supported by strong industry expertise. The company serves global markets with a...
5-[(2R)-2-Aminopropyl]-1-[3-(benzoyloxy)propyl]- 2...
CAS Number : 239463-85-5
End Use API : Silodosin
About The Company : Indian Drugs And Chemicals supplies quality products using modern technologies, supported by strong industry expertise. The company serves global markets with a...
2-(2-(2,2,2- Trifluoroethoxy)phenoxy)ethyl Methane...
CAS Number : 160969-03-9
End Use API : Silodosin
About The Company : Indian Drugs And Chemicals supplies quality products using modern technologies, supported by strong industry expertise. The company serves global markets with a...
1-(3-Benzoyloxypropyl)-7-cyano-5- (2-nitropropyl) ...
CAS Number : 350797-56-7
End Use API : Silodosin
About The Company : Established in 1975, Acharya Group is a trusted and well-established chemical manufacturing company renowned for its commitment to technological excellence. Ach...

5-[(2R)-2-Aminopropyl]-1-[3-(benzoyloxy)propyl]-2,...
CAS Number : 239463-85-5
End Use API : Silodosin
About The Company : Anhui Haikang Pharmaceutical Co., Ltd. was established in 2009 and located in a High-tech industry park, Anqing City, Anhui Province---a famous historical and c...

2-[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl methanes...
CAS Number : 160969-03-9
End Use API : Silodosin
About The Company : Anhui Haikang Pharmaceutical Co., Ltd. was established in 2009 and located in a High-tech industry park, Anqing City, Anhui Province---a famous historical and c...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Regulatory Info : DISCN
Registration Country : USA
Brand Name : RAPAFLO
Dosage Form : CAPSULE;ORAL
Dosage Strength : 4MG
Packaging :
Approval Date : 2008-10-08
Application Number : 22206
Regulatory Info : DISCN
Registration Country : USA
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Regulatory Info : DISCN
Registration Country : USA
Brand Name : RAPAFLO
Dosage Form : CAPSULE;ORAL
Dosage Strength : 8MG
Packaging :
Approval Date : 2008-10-08
Application Number : 22206
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info :
Registration Country : China
Brand Name : Silodosin
Dosage Form : Capsule
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Silodosina Pensa
Dosage Form : Hard Capsule
Dosage Strength : 4MG
Packaging :
Approval Date : 01-08-2019
Application Number : 84228
Regulatory Info : Authorized
Registration Country : Spain
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Silodosina Pensa
Dosage Form : Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date : 01-08-2019
Application Number : 84227
Regulatory Info : Authorized
Registration Country : Spain
Indian Drugs & Chemicals – delivering trusted APIs, intermediates & fine chemicals worldwide with 40+ years of quality expertise.
Regulatory Info :
Registration Country : India
Brand Name : Silodosin
Dosage Form : Immediate-Release Pellets
Dosage Strength : 1.8%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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RLD : Yes
TE Code :
Brand Name : RAPAFLO
Dosage Form : CAPSULE;ORAL
Dosage Strength : 4MG
Approval Date : 2008-10-08
Application Number : 22206
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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RLD : Yes
TE Code :
Brand Name : RAPAFLO
Dosage Form : CAPSULE;ORAL
Dosage Strength : 8MG
Approval Date : 2008-10-08
Application Number : 22206
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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RLD : No
TE Code : AB
Brand Name : SILODOSIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 4MG
Approval Date : 2018-12-03
Application Number : 211060
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : SILODOSIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 8MG
Approval Date : 2018-12-03
Application Number : 211060
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : SILODOSIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 8MG
Approval Date : 2018-12-10
Application Number : 210626
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : SILODOSIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 4MG
Approval Date : 2018-12-03
Application Number : 206541
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : SILODOSIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 8MG
Approval Date : 2018-12-03
Application Number : 206541
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : SILODOSIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 4MG
Approval Date : 2018-12-03
Application Number : 210687
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : SILODOSIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 8MG
Approval Date : 2018-12-03
Application Number : 210687
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Brand Name : SILODOSIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 4MG
Approval Date : 2022-01-04
Application Number : 209029
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]Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Silodosina Pensa
Dosage Form : Hard Capsule
Dosage Strength : 4MG
Packaging :
Approval Date : 01-08-2019
Application Number : 84228
Regulatory Info : Authorized
Registration Country : Spain
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Silodosina Pensa
Dosage Form : Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date : 01-08-2019
Application Number : 84227
Regulatory Info : Authorized
Registration Country : Spain
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Regulatory Info :
Registration Country : Italy
Brand Name : SILODOSINA KRKA
Dosage Form : Capsule
Dosage Strength :
Packaging : 30 UNITS 4 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info :
Registration Country : Turkey
Brand Name : Silodopin
Dosage Form : Capsule
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey

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Regulatory Info :
Registration Country : Italy
Brand Name : UROREC
Dosage Form : Hard Capsule
Dosage Strength : 8mg
Packaging : 30 UNITS 8 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Urorec
Dosage Form : Capsule
Dosage Strength : 4mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Silodyx
Dosage Form : Hard Capsule
Dosage Strength : 4MG
Packaging :
Approval Date : 03-06-2014
Application Number : 09607004IP
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Silodyx
Dosage Form : Hard Capsule
Dosage Strength : 8MG
Packaging :
Approval Date : 07-02-2020
Application Number : 09607011IP4
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : AURO-SILODOSIN
Dosage Form : CAPSULE
Dosage Strength : 4MG
Packaging : 30/90/500
Approval Date :
Application Number : 2478501
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : AURO-SILODOSIN
Dosage Form : CAPSULE
Dosage Strength : 8MG
Packaging : 30/90/500
Approval Date :
Application Number : 2478528
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : JAMP SILODOSIN
Dosage Form : CAPSULE
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number : 2539519
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : JAMP SILODOSIN
Dosage Form : CAPSULE
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number : 2539527
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : PMS-SILODOSIN
Dosage Form : CAPSULE
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number : 2517779
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : PMS-SILODOSIN
Dosage Form : CAPSULE
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number : 2517787
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : SANDOZ SILODOSIN
Dosage Form : CAPSULE
Dosage Strength : 4MG
Packaging : 30/100
Approval Date :
Application Number : 2475421
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : SANDOZ SILODOSIN
Dosage Form : CAPSULE
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number : 2475448
Regulatory Info : PRESCRIPTION
Registration Country : Canada

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Regulatory Info :
Registration Country : Australia
Brand Name : Urorec
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Registration Country : Australia
Brand Name : Urorec
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Packaging : 30
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Regulatory Info :
Registration Country : Australia

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Registration Country : Australia
Brand Name : Urorec
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Packaging : 30
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Regulatory Info :
Registration Country : Australia

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Brand Name : Urorec
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Packaging : 30
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Regulatory Info :
Registration Country : Australia

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Silodyx 4
Dosage Form : CAP
Dosage Strength : 4mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Silodyx 8
Dosage Form : CAP
Dosage Strength : 8mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Sildos 4mg
Dosage Form : CAP
Dosage Strength : 4mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Sildos 8mg
Dosage Form : CAP
Dosage Strength : 8mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Silprosia 4
Dosage Form : CAP
Dosage Strength : 4mg
Packaging : 30X1mg
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Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Silprosia 8
Dosage Form : CAP
Dosage Strength : 8mg
Packaging : 30X1mg
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Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : MAKDOSIN 4 mg
Dosage Form : CAP
Dosage Strength : 4mg
Packaging : 30X1mg
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Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : MAKDOSIN 8 mg
Dosage Form : CAP
Dosage Strength : 8mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 4MG
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Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
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Regulatory Info : Status- Under Registration
Dosage : Hard Capsule
Dosage Strength : 4MG
Brand Name :
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Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 8MG
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Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Packaging :
Regulatory Info : Status- Under Registration
Dosage : Hard Capsule
Dosage Strength : 8MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Germany
Regulatory Info :
Registration Country : China
Brand Name : Silodosin
Dosage Form : Capsule
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 4MG
Brand Name : Silodosin
Approval Date :
Application Number :
Registration Country : China
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Regulatory Info :
Registration Country : India
Brand Name : Silodosin
Dosage Form : Immediate-Release Pell...
Dosage Strength : 1.8%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Indian Drugs & Chemicals – delivering trusted APIs, intermediates & fine chemicals worldwide with 40+ years of quality expertise.
Packaging :
Regulatory Info :
Dosage : Immediate-Release Pell...
Dosage Strength : 1.8%
Brand Name : Silodosin
Approval Date :
Application Number :
Registration Country : India
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Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : FILM COATED TABLET
Dosage Strength : 8MG
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Application Number :
Regulatory Info : Generic
Registration Country : India

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Regulatory Info : Generic
Dosage : FILM COATED TABLET
Dosage Strength : 8MG
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Application Number :
Registration Country : India

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Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 4MG
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Application Number :
Regulatory Info :
Registration Country : India

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Dosage : Capsule
Dosage Strength : 4MG
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Application Number :
Registration Country : India

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Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 8MG
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Application Number :
Regulatory Info :
Registration Country : India

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Registration Country : India

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Registration Country : India
SILODOSIN + DUTASTERIDE TABLETS
Brand Name : SILOSAM-D4
Dosage Form : Tablet
Dosage Strength : 4MG;0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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SILODOSIN + DUTASTERIDE TABLETS
Dosage : Tablet
Dosage Strength : 4MG;0.5MG
Brand Name : SILOSAM-D4
Approval Date :
Application Number :
Registration Country : India

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Regulatory Info : Generic EU CTD
Registration Country : India
Brand Name :
Dosage Form : CAPSULE
Dosage Strength : 4MG
Packaging :
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Application Number :
Regulatory Info : Generic EU CTD
Registration Country : India

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Regulatory Info : Generic EU CTD
Dosage : CAPSULE
Dosage Strength : 4MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India

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Registration Country : India
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Dosage Form : Capsule
Dosage Strength : 4MG
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Regulatory Info :
Registration Country : India

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Dosage : Capsule
Dosage Strength : 4MG
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Registration Country : India

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Patents & EXCLUSIVITIES
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ABOUT THIS PAGE
41
PharmaCompass offers a list of Silodosin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Silodosin manufacturer or Silodosin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Silodosin manufacturer or Silodosin supplier.
A Silodyx manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Silodyx, including repackagers and relabelers. The FDA regulates Silodyx manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Silodyx 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 Silodyx manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Silodyx supplier is an individual or a company that provides Silodyx active pharmaceutical ingredient (API) or Silodyx finished formulations upon request. The Silodyx suppliers may include Silodyx API manufacturers, exporters, distributors and traders.
click here to find a list of Silodyx suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Silodyx DMF (Drug Master File) is a document detailing the whole manufacturing process of Silodyx active pharmaceutical ingredient (API) in detail. Different forms of Silodyx DMFs exist exist since differing nations have different regulations, such as Silodyx USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Silodyx DMF submitted to regulatory agencies in the US is known as a USDMF. Silodyx USDMF includes data on Silodyx's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Silodyx USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Silodyx 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 Silodyx Drug Master File in Japan (Silodyx JDMF) empowers Silodyx 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 Silodyx JDMF during the approval evaluation for pharmaceutical products. At the time of Silodyx 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 Silodyx 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 Silodyx Drug Master File in Korea (Silodyx KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Silodyx. The MFDS reviews the Silodyx KDMF as part of the drug registration process and uses the information provided in the Silodyx KDMF to evaluate the safety and efficacy of the drug.
After submitting a Silodyx 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 Silodyx API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Silodyx suppliers with KDMF on PharmaCompass.
A Silodyx written confirmation (Silodyx WC) is an official document issued by a regulatory agency to a Silodyx manufacturer, verifying that the manufacturing facility of a Silodyx active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Silodyx APIs or Silodyx finished pharmaceutical products to another nation, regulatory agencies frequently require a Silodyx WC (written confirmation) as part of the regulatory process.
click here to find a list of Silodyx 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 Silodyx as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Silodyx 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 Silodyx 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 Silodyx and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Silodyx NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Silodyx suppliers with NDC on PharmaCompass.
Silodyx 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 Silodyx GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Silodyx GMP manufacturer or Silodyx GMP API supplier for your needs.
A Silodyx CoA (Certificate of Analysis) is a formal document that attests to Silodyx's compliance with Silodyx specifications and serves as a tool for batch-level quality control.
Silodyx CoA mostly includes findings from lab analyses of a specific batch. For each Silodyx 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.
Silodyx may be tested according to a variety of international standards, such as European Pharmacopoeia (Silodyx EP), Silodyx JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Silodyx USP).