Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. 17beta-n-(2,5-bis(trifluoromethyl))phenyl-carbamoyl-4-aza-5alpha-androst-1-en-3-one
2. 745, Gg
3. Avodart
4. Gg 745
5. Gg-745
6. Gg745
7. Gi198745
1. 164656-23-9
2. Avodart
3. Avolve
4. Gg-745
5. Gi 198745
6. Gi-198745
7. Gg 745
8. Duastride
9. (1s,3as,3bs,5ar,9ar,9bs,11as)-n-[2,5-bis(trifluoromethyl)phenyl]-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide
10. Nsc-740477
11. O0j6xjn02i
12. (5alpha,17beta)-n-(2,5-bis(trifluoromethyl)phenyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide
13. Alpha,alpha,alpha,alpha',alpha',alpha'-hexafluoro-3-oxo-4-aza-5alpha-androst-1-ene-17beta-carboxy-2',5'-xylidide
14. Chembl1200969
15. Chebi:521033
16. Nsc-759880
17. (1s,3as,3bs,5ar,9ar,11as)-n-[2,5-bis(trifluoromethyl)phenyl]-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide
18. (4ar,4bs,6as,7s,9as,9bs,11ar)-n-(2,5-bis(trifluoromethyl)phenyl)-4a,6a-dimethyl-2-oxo-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-1h-indeno[5,4-f]quinoline-7-carboxamide
19. (1s,2r,7r,10s,11s,14s,15s)-n-[2,5-bis(trifluoromethyl)phenyl]-2,15-dimethyl-5-oxo-6-azatetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-3-ene-14-carboxamide
20. Dutasteride [usan]
21. Duagen
22. 1h-indeno[5,4-f]quinoline-7-carboxamide, N-[2,5-bis(trifluoromethyl)phenyl]-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-4a,6a-dimethyl-2-oxo-, (4ar,4bs,6as,7s,9as,9bs,11ar)-
23. Avodart (tn)
24. Unii-o0j6xjn02i
25. Avidart
26. Gi198745
27. Dutasteride [usan:inn:ban]
28. Ncgc00164571-01
29. (5alpha,17beta)-n-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-1-ene-17-carboxamide
30. 1h-indeno(5,4-f)quinoline-7-carboxamide, N-(2,5-bis(trifluoromethyl)phenyl)-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-4a,6a-dimethyl-2-oxo-, (4ar,4bs,6as,7s,9as,9bs,11ar)-
31. Dutasteride- Bio-x
32. Gi-198745x
33. Dutasteride [mi]
34. Dutasteride [inn]
35. Dutasteride [jan]
36. Dutasteride [vandf]
37. Schembl5903
38. Dsstox_cid_26452
39. Dsstox_rid_81626
40. Dutasteride [mart.]
41. Dsstox_gsid_46452
42. Dutasteride [usp-rs]
43. Dutasteride [who-dd]
44. Dutasteride (jan/usp/inn)
45. Gtpl7457
46. Dtxsid8046452
47. Dutasteride, >=98% (hplc)
48. Dutasteride [orange Book]
49. Dutasteride For System Suitability
50. Jalyn Component Dutasteride
51. Bcpp000248
52. Dutasteride [ep Monograph]
53. Dutasteride [usp Monograph]
54. Bcp02344
55. Ex-a1952
56. Zinc3932831
57. Tox21_112199
58. Bdbm50340481
59. Mfcd00937869
60. Nsc740477
61. S1202
62. Dutasteride Component Of Jalyn
63. Akos015920136
64. Akos015924431
65. Bcp9000630
66. Ccg-269904
67. Cs-1542
68. Db01126
69. Gs-3565
70. Nsc 740477
71. Nsc 759880
72. N-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5alpha-androst-1-ene-17beta-carboxamide
73. Bd164398
74. Hy-13613
75. Cas-164656-23-9
76. D5973
77. D03820
78. Ab01274774-01
79. Ab01274774_02
80. 656d239
81. A810580
82. Q424760
83. Q-201052
84. Brd-k30373883-001-02-8
85. Z1563146168
86. Dutasteride, European Pharmacopoeia (ep) Reference Standard
87. Dutasteride, United States Pharmacopeia (usp) Reference Standard
88. 4-azaandrost-1-ene-17-carboxamide, N-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-, (5a,17b)-
89. Dutasteride For System Suitability, European Pharmacopoeia (ep) Reference Standard
90. (4ar,4bs,6as,7s,9as,9bs,11ar)-n-[2,5-bis(trifluoromethyl)phenyl]-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-4a,6a-dimethyl-2-oxo-1h-indeno[5,4-f]quinoline-7-carboxamide
91. (5.alpha.,17.beta.)-n-(2,5-bis(trifluoromethyl)phenyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide
92. (5.alpha.,5 Bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide;dutasteride;avodart;
93. (5alpha,17beta)-n-{2,5-bis(trifluoromethyl)-phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide
94. .alpha.,.alpha.,.alpha.,.alpha.',.alpha.',.alpha.'-hexafluoro-3-oxo-4-aza-5.alpha.-androst-1-ene-17.beta.-carboxy-2',5'-xylidide
| Molecular Weight | 528.5 g/mol |
|---|---|
| Molecular Formula | C27H30F6N2O2 |
| XLogP3 | 5.4 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 2 |
| Exact Mass | 528.22114718 g/mol |
| Monoisotopic Mass | 528.22114718 g/mol |
| Topological Polar Surface Area | 58.2 Ų |
| Heavy Atom Count | 37 |
| Formal Charge | 0 |
| Complexity | 964 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 7 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 4 | |
|---|---|
| Drug Name | Avodart |
| PubMed Health | Dutasteride (By mouth) |
| Drug Classes | Benign Prostatic Hypertrophy Agent |
| Drug Label | AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5,17... |
| Active Ingredient | Dutasteride |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | 0.5mg |
| Market Status | Prescription |
| Company | Glaxosmithkline |
| 2 of 4 | |
|---|---|
| Drug Name | Dutasteride |
| PubMed Health | Dutasteride (By mouth) |
| Drug Classes | Benign Prostatic Hypertrophy Agent |
| Drug Label | AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5,17... |
| Active Ingredient | Dutasteride |
| Dosage Form | Capsule |
| Route | oral; Oral |
| Strength | 0.5mg |
| Market Status | Tentative Approval; Prescription |
| Company | Endo Pharms; Sandoz; Banner Pharmacaps; Roxane; Barr |
| 3 of 4 | |
|---|---|
| Drug Name | Avodart |
| PubMed Health | Dutasteride (By mouth) |
| Drug Classes | Benign Prostatic Hypertrophy Agent |
| Drug Label | AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5,17... |
| Active Ingredient | Dutasteride |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | 0.5mg |
| Market Status | Prescription |
| Company | Glaxosmithkline |
| 4 of 4 | |
|---|---|
| Drug Name | Dutasteride |
| PubMed Health | Dutasteride (By mouth) |
| Drug Classes | Benign Prostatic Hypertrophy Agent |
| Drug Label | AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5,17... |
| Active Ingredient | Dutasteride |
| Dosage Form | Capsule |
| Route | oral; Oral |
| Strength | 0.5mg |
| Market Status | Tentative Approval; Prescription |
| Company | Endo Pharms; Sandoz; Banner Pharmacaps; Roxane; Barr |
Indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland to improve symptoms, and reduce the risk of acute urinary retention and the need for BPH-related surgery alone or in combination with [tamsulosin].
Dutasteride is a synthetic 4-azasteroid compound that selectively inhibits both the type I and type II isoforms of steroid 5-reductase, an intracellular enzyme that converts testosterone to 5-dihydrotestosterone (DHT). Dutasteride works by reducing the levels of circulating DHT. It was also shown to reduce the size of the prostate gland, improve urinary flow, and symptoms of benign prostatic hyperplasia alone or in combination with tamsulosin. The effect of the reduction of DHT by dutasteride is dose-dependent, with the maximum effect observed within 1-2 weeks following initial administration. After 1 and 2 weeks of daily dosing with dutasteride 0.5 mg, median serum DHT concentrations were reduced by 85% and 90%, respectively. The serum concentrations of DHT were maintained to be decreased by more than 90% in 85% of patients following 1 years' administration of oral dutasteride 0.5 mg/day. As evident from the clinical studies, dutasteride may also cause decreases in serum PSA in the presence of prostate cancer.
5-alpha Reductase Inhibitors
Drugs that inhibit 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE. They are commonly used to reduce the production of DIHYDROTESTOSTERONE. (See all compounds classified as 5-alpha Reductase Inhibitors.)
G04CB02
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
G04CB - Testosterone-5-alpha reductase inhibitors
G04CB02 - Dutasteride
Absorption
Following oral administration of a single dose of 0.5 mg dutasteride, the peak serum concentrations were reached within 2 to 3 hours. Following daily oral administration of 0.5 mg dutasteride, the steady-state concentration of 40 ng/mL is expected to be achieved at 6 months following initial administration. In healthy subjects, the absolute bioavailability was 60%, ranging from 40% to 94%. While food intake reduced the maximum serum concentrations by 10 to 15%, food intake is reported to have a negligible effect on the bioavailability of the drug.
Route of Elimination
Dutasteride and its metabolites mainly undergo fecal excretion. About 1-15% of the dose is excreted as the unchanged parent compound, while 2-90% of the total dose is excreted in the form of dutasteride-related metabolites in the feces. Trace amounts of unchanged dutasteride, with less than 1%, can also be detected in the urine. Therefore, on average, the dose unaccounted for approximated 55%, with a range between 5% and 97%.
Volume of Distribution
Dutasteride displays a large volume of distribution ranging from 300 to 500 L. Following daily oral administration of 0.5 mg dutasteride healthy subjects for 12 months, the semen dutasteride concentrations averaged 3.4 ng/mL (range: 0.4 to 14 ng/mL) with 11.5% of serum dutasteride concentrations being partitioned into semen.
Clearance
In a study of healthy volunteers receiving single oral doses of dutasteride ranging from 0.01 to 40 mg, dutasteride displayed a low linear clearance of 0.58 L/h. The estimated inter-individual variability for the linear clearance was high.
Dutasteride undergoes extensive hepatic metabolism mediated by CYP3A4 and CYP3A5. 4-hydroxydutasteride, 6-hydroxydutasteride, 6,4-dihydroxydutasteride, 1,2-dihydrodutasteride, and 15-hydroxydutasteride metabolites are formed. 2 minor metabolites - 6,4-dihydroxydutasteride and 15-hydroxydutasteride - can also be detected. According to _in vitro_ studies, 4-hydroxydutasteride and 1,2-dihydrodutasteride mediated inhibitory actions against both isoforms of 5-reductase but with lower potency when compared to the parent drug. The activity of 6-hydroxydutasteride is comparable to that of dutasteride.
The terminal elimination half-life of dutasteride is approximately 5 weeks at steady state. This long half-life accounts for the serum concentrations remaining detectable for up to 4 to 6 months after discontinuation of treatment.
The 5-reductase is a nuclear-bound steroid intracellular enzyme primarily located in the prostatic stromal cell that converts the androgen testosterone into the more active metabolite, 5-dihydrotestosterone (DHT). DHT is considered to be the primary androgen playing a role in the initial development and subsequent enlargement of the prostate gland. It serves as the hormonal mediator for the hyperplasia upon accumulation within the prostate gland. DHT displays a higher affinity towards androgen receptors in the prostate gland compared to testosterone and by acting on the androgen receptors, DHT modulates genes that are responsible for cell proliferation. Responsible for the synthesis of approximately one-third of circulating DHT, type I 5-reductase is predominant in the sebaceous glands of most regions of skin, including the scalp, and liver. The type II 5a-reductase isozyme is primarily found in the prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT. Due to its dual inhibition of both isoenzymes of 5-reductase, dutasteride causes a near-complete suppression of DHT. Compared to a 70% reduction of serum DHT levels caused by [finasteride], a near-complete suppression of serum DHT-more than 90% is seen with dutasteride. By forming a stable complex with both type II and type II 5-reductase, dutasteride inhibits its enzymatic action of converting testosterone to 5-dihydrotestosterone (DHT), which is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. It is proposed that DHT is the principal androgen responsible for prostatic growth in later life-normal masculinization of the external genitalia and maturation of the prostate gland during development-thus reducing the serum DHT levels results in reduced prostatic volume and increased epithelial apoptosis. Dutasteride is a competitive and specific inhibitor of both Type I and Type II 5-reductase isoenzymes and when evaluated under _in vitro_ and _in vivo_ conditions, the dissociation of the drug from the drug-enzyme complex is reported to be extremely slow. Dutasteride does not bind to the human androgen receptor.
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE;ORAL - 0.5MG
USFDA APPLICATION NUMBER - 21319
DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG
USFDA APPLICATION NUMBER - 22460
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seqens
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vertellus
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Coating Systems & Additives
Fillers, Diluents & Binders
Controlled & Modified Release
Thickeners and Stabilizers
Solubilizers
Film Formers & Plasticizers
Parenteral
Topical
Taste Masking
Direct Compression
Granulation
Co-Processed Excipients
Empty Capsules
Disintegrants & Superdisintegrants
Chewable & Orodispersible Aids
Emulsifying Agents
Surfactant & Foaming Agents
Rheology Modifiers
Lubricants & Glidants
Coloring Agents
Vegetarian Capsules
API Stability Enhancers
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
64
PharmaCompass offers a list of Dutasteride 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 Dutasteride manufacturer or Dutasteride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dutasteride manufacturer or Dutasteride supplier.
PharmaCompass also assists you with knowing the Dutasteride API Price utilized in the formulation of products. Dutasteride API Price is not always fixed or binding as the Dutasteride Price is obtained through a variety of data sources. The Dutasteride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dutasteride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dutasteride, including repackagers and relabelers. The FDA regulates Dutasteride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dutasteride 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 Dutasteride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dutasteride supplier is an individual or a company that provides Dutasteride active pharmaceutical ingredient (API) or Dutasteride finished formulations upon request. The Dutasteride suppliers may include Dutasteride API manufacturers, exporters, distributors and traders.
click here to find a list of Dutasteride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dutasteride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dutasteride active pharmaceutical ingredient (API) in detail. Different forms of Dutasteride DMFs exist exist since differing nations have different regulations, such as Dutasteride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dutasteride DMF submitted to regulatory agencies in the US is known as a USDMF. Dutasteride USDMF includes data on Dutasteride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dutasteride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dutasteride 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 Dutasteride Drug Master File in Japan (Dutasteride JDMF) empowers Dutasteride 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 Dutasteride JDMF during the approval evaluation for pharmaceutical products. At the time of Dutasteride 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 Dutasteride 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 Dutasteride Drug Master File in Korea (Dutasteride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dutasteride. The MFDS reviews the Dutasteride KDMF as part of the drug registration process and uses the information provided in the Dutasteride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dutasteride 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 Dutasteride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dutasteride suppliers with KDMF on PharmaCompass.
A Dutasteride CEP of the European Pharmacopoeia monograph is often referred to as a Dutasteride Certificate of Suitability (COS). The purpose of a Dutasteride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dutasteride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dutasteride to their clients by showing that a Dutasteride CEP has been issued for it. The manufacturer submits a Dutasteride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dutasteride CEP holder for the record. Additionally, the data presented in the Dutasteride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dutasteride DMF.
A Dutasteride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dutasteride 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 Dutasteride suppliers with CEP (COS) on PharmaCompass.
A Dutasteride written confirmation (Dutasteride WC) is an official document issued by a regulatory agency to a Dutasteride manufacturer, verifying that the manufacturing facility of a Dutasteride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dutasteride APIs or Dutasteride finished pharmaceutical products to another nation, regulatory agencies frequently require a Dutasteride WC (written confirmation) as part of the regulatory process.
click here to find a list of Dutasteride 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 Dutasteride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dutasteride 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 Dutasteride 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 Dutasteride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dutasteride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dutasteride suppliers with NDC on PharmaCompass.
Dutasteride 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 Dutasteride 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 Dutasteride GMP manufacturer or Dutasteride GMP API supplier for your needs.
A Dutasteride CoA (Certificate of Analysis) is a formal document that attests to Dutasteride's compliance with Dutasteride specifications and serves as a tool for batch-level quality control.
Dutasteride CoA mostly includes findings from lab analyses of a specific batch. For each Dutasteride 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.
Dutasteride may be tested according to a variety of international standards, such as European Pharmacopoeia (Dutasteride EP), Dutasteride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dutasteride USP).
