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Dutasteride

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149 FDF Dossiers
25 FDA Orange Book
66 Europe
17 Canada
8 Australia
3 South Africa
30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 0.5MG, CAPSULE;ORAL - 0.5MG;0.4MG

drugProductComposition
CAPSULE;ORAL - 0.5MG
CAPSULE;ORAL - 0.5MG;0.4MG

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Synopsis

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149

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Europe

Canada

Australia

South Africa

Listed Dossiers

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Chemistry

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Also known as: 164656-23-9, Avodart, Avolve, Gg-745, Gi 198745, Gi-198745

Molecular Formula

C₂₇H₃₀F₆N₂O₂

Molecular Weight

528.5 g/mol

InChI Key

JWJOTENAMICLJG-QWBYCMEYSA-N

FDA UNII

O0J6XJN02I

A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.

Dutasteride is a 5-alpha Reductase Inhibitor. The mechanism of action of dutasteride is as a 5-alpha Reductase Inhibitor.

1 2D Structure

Dutasteride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(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

2.1.2 InChI

InChI=1S/C27H30F6N2O2/c1-24-11-9-17-15(4-8-21-25(17,2)12-10-22(36)35-21)16(24)6-7-19(24)23(37)34-20-13-14(26(28,29)30)3-5-18(20)27(31,32)33/h3,5,10,12-13,15-17,19,21H,4,6-9,11H2,1-2H3,(H,34,37)(H,35,36)/t15-,16-,17-,19+,21+,24-,25+/m0/s1

2.1.3 InChI Key

JWJOTENAMICLJG-QWBYCMEYSA-N

2.1.4 Canonical SMILES

CC12CCC3C(C1CCC2C(=O)NC4=C(C=CC(=C4)C(F)(F)F)C(F)(F)F)CCC5C3(C=CC(=O)N5)C

2.1.5 Isomeric SMILES

C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2C(=O)NC4=C(C=CC(=C4)C(F)(F)F)C(F)(F)F)CC[C@@H]5[C@@]3(C=CC(=O)N5)C

2.2 Other Identifiers

2.2.1 UNII

O0J6XJN02I

2.3 Synonyms

2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date

2006-07-28

3 Chemical and Physical Properties

Molecular Formula	C₂₇H₃₀F₆N₂O₂
Molecular Weight	528.5 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Information

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

4.2 Drug Indication

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].

5 Pharmacology and Biochemistry

5.1 Pharmacology

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.

5.2 MeSH Pharmacological Classification

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.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

DUTASTERIDE

5.3.2 FDA UNII

O0J6XJN02I

5.3.3 Pharmacological Classes

5-alpha Reductase Inhibitors [MoA]; 5-alpha Reductase Inhibitor [EPC]

5.4 ATC Code

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

5.5 Absorption, Distribution and Excretion

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.

5.6 Metabolism/Metabolites

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.

5.7 Biological Half-Life

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.

5.8 Mechanism of Action

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.

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DUTASTERIDE (PROCESS-II) USP

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-12

Pay. Date : 2012-11-30

DMF Number : 26475

Submission : 2012-10-03

Status : Active

Type : II

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Duphat

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09

Reliance Life Sciences Pvt Ltd

India

Duphat

Not Confirmed

10

Sterling Spa

Italy

Duphat

Not Confirmed

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CEP/COS

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JDMF

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

01 Dongkook Pharmaceutical

South Korea

Pharmatech Expo 2025

Not Confirmed

02 Yuyu Pharma

South Korea

Pharmatech Expo 2025

Not Confirmed

03 Corpometria Institute

Country

Pharmatech Expo 2025

Not Confirmed

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

01

STRIDES PHARMA

India

PharmaVenue

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code :

DUTASTERIDE

Brand Name : DUTASTERIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG

Approval Date : 2018-06-22

Application Number : 208227

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

PharmaVenue

Not Confirmed

10

NORVIUM BIOSCIENCE

Country

PharmaVenue

Not Confirmed

Only 10 entries up to this point, click to access all

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Europe

01

Helvepharm AG

France

PharmaVenue

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

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

Portfolio PDF

Product Web Link

02

Helvepharm AG

France

PharmaVenue

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

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

Portfolio PDF

Product Web Link

03

Helvepharm AG

France

PharmaVenue

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

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

Portfolio PDF

Product Web Link

04

TOWA PHARMACEUTICAL SPA

Japan

PharmaVenue

Not Confirmed

Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

Contact Supplier

Japan

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Italy

Dutasteride

Brand Name : DUTASTERIDE PENSA

Dosage Form : Capsule

Dosage Strength : 0.5mg

Packaging : 30 UNITS 0.5 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

05

ECUPHARMA SRL

Italy

U.S.A

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Not Confirmed

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Canada

01

APOTEX INC

PharmaVenue

Not Confirmed

09

SIVEM PHARMACEUTICALS ULC

Canada

PharmaVenue

Not Confirmed

10

TEVA CANADA LIMITED

Israel

PharmaVenue

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Australia

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South Africa

01

Cipla Medpro (Pty) Ltd

South Africa

PharmaVenue

Not Confirmed

02

GlaxoSmithKline South Africa (Pty) Limit...

United Kingdom

PharmaVenue

Not Confirmed

03

GlaxoSmithKline South Africa (Pty) Limit...

United Kingdom

PharmaVenue

Not Confirmed

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Listed Dossiers

01

Douglas Pharmaceuticals Ltd.

New Zealand

DCAT Week

Attending

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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New Zealand

Virtual Booth

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Regulatory Info : Generic

Registration Country : New Zealand

Dutasteride

Brand Name :

Dosage Form : TABLET

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

Portfolio PDF

Corporate PDF

02

Olpha

Latvia

PharmaVenue

Not Confirmed

Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.

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Latvia

Virtual Booth

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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

03

Strides Pharma Science

India

PharmaVenue

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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India

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Regulatory Info :

Registration Country : India

Dutasteride

Brand Name :

Dosage Form : Soft Gel Capsule

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Portfolio PDF

Product Web Link

Turkey

PharmaVenue

Not Confirmed

10

Zota Healthcare Ltd

India

PharmaVenue

Not Confirmed

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 0.5MG

USFDA APPLICATION NUMBER - 21319

DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG

USFDA APPLICATION NUMBER - 22460

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Coating Systems & Additives

Fillers, Diluents & Binders

Controlled & Modified Release

Thickeners and Stabilizers

Solubilizers

Direct Compression

Film Formers & Plasticizers

Topical

Parenteral

01

Seqens

France

Pharmatech Expo 2025

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Expansorb® PLA / PEG

Application : Parenteral

Excipient Details : Expansorb® PLA?/PEG? polymers are used as functional excipients in injectable formulations for controlled & slow drug release with a single injection.

Pharmacopoeia Ref : N/A

Technical Specs : Classic and ultrapure LMP

Ingredient(s) : Poly lactic acid

02

Faran Shimi Pharmaceutical

Iran

Pharmatech Expo 2025

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Potassium Chloride

Application : Parenteral

Excipient Details : Potassium chloride is used as a diuretic-osmotic in injectable and parenteral solutions.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Potassium Chloride Excipient

03

Nanjing Well Pharmaceutical

China

Pharmatech Expo 2025

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet

Grade : Parenteral, Oral, Topical

Category : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polysorbate 20

Application : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : Polysorbate 20 is used in parenteral products such as biologics. It is used as a solubilizer, surfactant, emulsifier & suspension stabilizer.

Pharmacopoeia Ref : ChP/USP/EP

Technical Specs : NA

Ingredient(s) : Polysorbate 20

04

Pfanstiehl

U.S.A

Pharmatech Expo 2025

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral, Thickeners and Stabilizers

Brand Name : Sucrose

Application : Parenteral, Thickeners and Stabilizers

Excipient Details : Sucrose is used to stabilize proteins, lipids, carbohydrates, ADCs & vaccines. It is also used as a cryopreservative in cell-based bioprocesses.

Pharmacopoeia Ref : USDMF, NF, EP, JP, ChP

Technical Specs : N/A

Ingredient(s) : Sucrose

05

Seqens

France

Pharmatech Expo 2025

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Expansorb® PLGA / PEG

Application : Parenteral

Excipient Details : Expansorb® PLGA? / PEG copolymers are used as functional excipients in single dose injections for controlled and slow drug release (weeks to months).

Pharmacopoeia Ref : N/A

Technical Specs : Classic and ultrapure LMP

Ingredient(s) : Poly-DL-Lactic-co-Glycolic Acid

06

Pluviaendo

Turkey

Pharmatech Expo 2025

Not Confirmed

07

Nanjing Well Pharmaceutical

China

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet

Grade : Parenteral, Oral, Topical

Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polysorbate 80

Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Polysorbate 80

08

Nanjing Well Pharmaceutical

China

Pharmatech Expo 2025

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Emulsion, Injectable / Parenteral

Grade : Parenteral

Category : Emulsifying Agents, Parenteral, Solubilizers

Brand Name : Soybean Lecithin

Application : Emulsifying Agents, Parenteral, Solubilizers

Excipient Details : Soya lecithin is used as solubilizer & emulsifier in parenteral dosage forms such as fat emulsion injections, mixed micelle preparations & emulsions.

Pharmacopoeia Ref : ChP/EP

Technical Specs : NA

Ingredient(s) : Soya Lecithin

09

Pluviaendo

Turkey

Pharmatech Expo 2025

Not Confirmed

10

Nanjing Well Pharmaceutical

China

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgels

Grade : Parenteral, Oral, Topical

Category : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical

Brand Name : Propylene Glycol

Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical

Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Propylene Glycol

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ABOUT THIS PAGE

Dutasteride Manufacturers

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.

Dutasteride Suppliers

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.

Dutasteride USDMF

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.

Dutasteride JDMF

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.

Dutasteride KDMF

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.

Dutasteride CEP

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.

Dutasteride WC

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.

Dutasteride NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Dutasteride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Dutasteride CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers

17 USDMF

6 CEP/COS

7 JDMF

5 EU WC

25 KDMF

20 NDC API

27 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

149 FDF Dossiers

25 FDA Orange Book

66 Europe

17 Canada

8 Australia

3 South Africa

30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 0.5MG

CAPSULE;ORAL - 0.5MG;0.4MG

RELATED EXCIPIENT COMPANIES

2 Evonik

2 Rochem International Inc

7 SPI Pharma

2 Seqens

10 DKSH

3 Faran Shimi Pharmaceutical

10 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 ACG Worldwide

8 Actylis

1 Aeon Procare

3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

12 Corel Pharma Chem

2 DFE Pharma

3 Finar

8 Gangwal Chemicals

10 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

17 Kerry

4 Kima Chemical

6 Lonza Capsugel

5 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

1 Pharmatrans-Sanaq

4 Pluviaendo

1 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

24 Roquette

16 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

9 Sigachi Industries

3 The Dow Chemical Company

1 Valens Pharmachem

1 Vasa Pharmachem

2 Vertellus

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

62 Coating Systems & Additives

43 Fillers, Diluents & Binders

36 Controlled & Modified Release

29 Thickeners and Stabilizers

24 Solubilizers

24 Direct Compression

24 Film Formers & Plasticizers

19 Topical