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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

Dutasteride
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 Weight 528.5 g/mol
Molecular Formula C27H30F6N2O2
XLogP35.4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count2
Exact Mass528.22114718 g/mol
Monoisotopic Mass528.22114718 g/mol
Topological Polar Surface Area58.2 Ų
Heavy Atom Count37
Formal Charge0
Complexity964
Isotope Atom Count0
Defined Atom Stereocenter Count7
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameAvodart
PubMed HealthDutasteride (By mouth)
Drug ClassesBenign Prostatic Hypertrophy Agent
Drug LabelAVODART 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 IngredientDutasteride
Dosage FormCapsule
RouteOral
Strength0.5mg
Market StatusPrescription
CompanyGlaxosmithkline

2 of 4  
Drug NameDutasteride
PubMed HealthDutasteride (By mouth)
Drug ClassesBenign Prostatic Hypertrophy Agent
Drug LabelAVODART 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 IngredientDutasteride
Dosage FormCapsule
Routeoral; Oral
Strength0.5mg
Market StatusTentative Approval; Prescription
CompanyEndo Pharms; Sandoz; Banner Pharmacaps; Roxane; Barr

3 of 4  
Drug NameAvodart
PubMed HealthDutasteride (By mouth)
Drug ClassesBenign Prostatic Hypertrophy Agent
Drug LabelAVODART 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 IngredientDutasteride
Dosage FormCapsule
RouteOral
Strength0.5mg
Market StatusPrescription
CompanyGlaxosmithkline

4 of 4  
Drug NameDutasteride
PubMed HealthDutasteride (By mouth)
Drug ClassesBenign Prostatic Hypertrophy Agent
Drug LabelAVODART 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 IngredientDutasteride
Dosage FormCapsule
Routeoral; Oral
Strength0.5mg
Market StatusTentative Approval; Prescription
CompanyEndo 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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C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"COMEXPORT TRADING COMERCIO","customerCountry":"BRAZIL","quantity":"1.16","actualQuantity":"1.16","unit":"KGS","unitRateFc":"20000","totalValueFC":"23104.3","currency":"USD","unitRateINR":1654000,"date":"12-Jul-2024","totalValueINR":"1918640","totalValueInUsd":"23104.3","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"2374576","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721673000,"product":"TAMSULOSIN HCL SR 0.4 MG & DUTASTERIDE IR 0.5 MG BLENDED PELLETS.","address":"102,TITAN HOUSE,60 FEET RD,","city":"MUMBAI, MAHARASHTRA","supplier":"TITAN LABORATORIES","supplierCountry":"INDIA","foreign_port":"GUATEMALA CITY","customer":"N.P.S.A.","customerCountry":"GUATEMALA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"397","totalValueFC":"5757.1","currency":"USD","unitRateINR":31872.48,"date":"23-Jul-2024","totalValueINR":"478087.2","totalValueInUsd":"5757.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"2619808","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"GUATEMALA","selfForZScoreResived":"Pellets","supplierPort":"Bombay Air","supplierAddress":"102,TITAN HOUSE,60 FEET RD,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721759400,"product":"DUTASTERIDE PH EUR","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"EMS","customerCountry":"BRAZIL","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"30000","totalValueFC":"59824.7","currency":"USD","unitRateINR":2484000,"date":"24-Jul-2024","totalValueINR":"4968000","totalValueInUsd":"59824.7","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"2655818","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721932200,"product":"DUTASTERIDE","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\\\\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"COSMAX PHARMA CO LTD","customerCountry":"REPUBLIC OF KOREA","quantity":"1.10","actualQuantity":"1.1","unit":"KGS","unitRateFc":"38000","totalValueFC":"41609.8","currency":"USD","unitRateINR":3141263.3909090906,"date":"26-Jul-2024","totalValueINR":"3455389.73","totalValueInUsd":"41609.8","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"2724288","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE, HYDERABAD ANDHRA PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"TAMSULOSIN HYDROCHLORIDE 0.4 MG AND DUTASTERIDE 0.5 MG BLENDED PELLETS","address":"102,TITAN HOUSE,60 FEET RD,","city":"MUMBAI, MAHARASHTRA","supplier":"TITAN LABORATORIES","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"C. B. L.","customerCountry":"BANGLADESH","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"179","totalValueFC":"26400.4","currency":"USD","unitRateINR":14615.76,"date":"30-Jul-2024","totalValueINR":"2192364","totalValueInUsd":"26400.4","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"2828334","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pellets","supplierPort":"Bombay Air","supplierAddress":"102,TITAN HOUSE,60 FEET RD,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722364200,"product":"DUTASTERIDE PH.EUR","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"PEILI PHARMACEUTICAL INDUSTRIAL","customerCountry":"TAIWAN","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"45000","totalValueFC":"22367.6","currency":"USD","unitRateINR":3714935.1400000001,"date":"31-Jul-2024","totalValueINR":"1857467.57","totalValueInUsd":"22367.6","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"2856658","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722537000,"product":"BLENDED PELLETS OF TAMSULOSIN HCL & DUTASTERIDE. (EACH 300MG OF BLENDED PELLETSCONTAINS 0.4MG OF TAMSULOSIN HCL & 0.5MG","address":"5-7-53, SANGEETHNAGAR","city":"HYDERABAD-A,P,","supplier":"PELLETS PHARMA LIMITED","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES, BA","customer":"PANALAB S.A. ARGENTINA","customerCountry":"ARGENTINA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"373","totalValueFC":"54692.6","currency":"USD","unitRateINR":30278.824933333333,"date":"02-Aug-2024","totalValueINR":"4541823.74","totalValueInUsd":"54692.6","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"2918130","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pellets","supplierPort":"Hyderabad Air","supplierAddress":"5-7-53, SANGEETHNAGAR, HYDERABAD-A,P,","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722882600,"product":"DUTASTERIDE PELLETS 0.5% W\/W (PHARMACEUTICAL RAW MATERIAL)","address":"FLAT NO.302, BHANU ENCLAVE","city":"HYDERABAD.AP","supplier":"METROCHEM API PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"GUAYAQUIL","customer":"LABORATORIOS ROCNARF S.A","customerCountry":"ECUADOR","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"265","totalValueFC":"10029.2","currency":"USD","unitRateINR":20821.325000000001,"date":"06-Aug-2024","totalValueINR":"832853","totalValueInUsd":"10029.2","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"2995895","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ECUADOR","selfForZScoreResived":"Pellets","supplierPort":"Hyderabad Air","supplierAddress":"FLAT NO.302, BHANU ENCLAVE, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724092200,"product":"DUTASTERIDE","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"APITORIA PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"TOKYO - NARITA","customer":"TOWA PHARMACEUTICAL","customerCountry":"JAPAN","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"85000","totalValueFC":"595201.6","currency":"USD","unitRateINR":7061019.345714286,"date":"20-Aug-2024","totalValueINR":"49427135.42","totalValueInUsd":"595201.6","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"3339268","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower, Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724351400,"product":"DUTASTERIDE PH EUR","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"KUKJEON PHARMACEUTICAL CO.,LTD,","customerCountry":"REPUBLIC OF KOREA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"20000","totalValueFC":"119982.2","currency":"USD","unitRateINR":1660607.6666666667,"date":"23-Aug-2024","totalValueINR":"9963646","totalValueInUsd":"119982.2","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"3432035","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724697000,"product":"DUTASTERIDE PH EUR","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"SAO PAULO - CONGONHA","customer":"COMEXPORT TRADING COMERCIO ","customerCountry":"BRAZIL","quantity":"1.16","actualQuantity":"1.16","unit":"KGS","unitRateFc":"20000","totalValueFC":"23216","currency":"USD","unitRateINR":1662000,"date":"27-Aug-2024","totalValueINR":"1927920","totalValueInUsd":"23216","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"3525939","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724783400,"product":"DUTASTERIDE PH.EUR","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"BUCHAREST, OTOPENI","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"HUNGARY","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"13000","totalValueFC":"78053.8","currency":"USD","unitRateINR":1080300,"date":"28-Aug-2024","totalValueINR":"6481800","totalValueInUsd":"78053.8","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"3558658","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"DUTASTERIDE USP","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"AMNEAL PHARMACEUTICALS,LLC,","customerCountry":"UNITED STATES","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"16000","totalValueFC":"23848.2","currency":"USD","unitRateINR":1320277.3333333333,"date":"31-Aug-2024","totalValueINR":"1980416","totalValueInUsd":"23848.2","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"3654357","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1638729000,"product":"DUTASTERIDE USP","address":"201, DEVAVRATA, SECTOR 17,,VASHI, NAVI MUMBAI,","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"STRIDES PHARMA SCIENCE","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"1.20","actualQuantity":"1.2","unit":"KGS","unitRateFc":"15750","totalValueFC":"19371.8","currency":"USD","unitRateINR":"1217618.5","date":"06-Dec-2021","totalValueINR":"1461142.15","totalValueInUsd":"19371.8","indian_port":"MADRAS SEA","hs_no":"29372900","bill_no":"6549085","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK","supplierAddress":"","customerAddress":"201, DEVAVRATA, SECTOR 17,,VASHI, NAVI MUMBAI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706121000,"product":"DUTASTERIDE HYDRATE BATCH NO.DT-005\/20","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"STERLING SPA","supplierCountry":"UNITED STATES","foreign_port":"MIAMI, FL","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"0.80","actualQuantity":"0.8","unit":"KGS","unitRateFc":"20000","totalValueFC":"16203.7","currency":"USD","unitRateINR":"1682000","date":"25-Jan-2024","totalValueINR":"1345600","totalValueInUsd":"16203.7","indian_port":"Madras Air","hs_no":"29349990","bill_no":"9825072","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"MIAMI, FL","supplierAddress":"RIEDSTRASSE 1CHAM ZUG 6330SDNF SWITZERLAND","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"}]
06-Jan-2021
31-Aug-2024
KGS
overview
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Average Price (USD/KGS)

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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FDA Orange Book

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01

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

DUTASTERIDE

Brand Name : DUTASTERIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG

Approval Date : 2015-11-20

Application Number : 204262

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

02

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content 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 :

Strides Pharma Science

03

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

DUTASTERIDE

Brand Name : DUTASTERIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG

Approval Date : 2015-11-20

Application Number : 202808

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Brand Name : DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG;0.4MG

Approval Date : 2015-11-20

Application Number : 202975

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

DUTASTERIDE

Brand Name : DUTASTERIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG

Approval Date : 2016-10-21

Application Number : 206574

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

DUTASTERIDE

Brand Name : DUTASTERIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG

Approval Date : 2015-11-20

Application Number : 203118

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

DUTASTERIDE

Brand Name : DUTASTERIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG

Approval Date : 2015-11-20

Application Number : 202660

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

DUTASTERIDE

Brand Name : AVODART

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG

Approval Date : 2001-11-20

Application Number : 21319

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Brand Name : JALYN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG;0.4MG

Approval Date : 2010-06-14

Application Number : 22460

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

ZYDUS PHARMS

U.S.A
26th North American ISSX
Not Confirmed
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ZYDUS PHARMS

U.S.A
arrow
26th North American ISSX
Not Confirmed

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Brand Name : DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG;0.4MG

Approval Date : 2018-05-24

Application Number : 207769

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Europe

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01

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

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

Flag France
Digital Content 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

Sanofi Company Banner

02

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

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

Flag France
Digital Content 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

Sanofi Company Banner

03

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

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

Flag France
Digital Content 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

Sanofi Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

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

Flag Japan
Digital Content 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

Towa Pharmaceutical

05

ACCORD HEALTHCARE SLU

United Kingdom
26th North American ISSX
Not Confirmed
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ACCORD HEALTHCARE SLU

United Kingdom
arrow
26th North American ISSX
Not Confirmed

Dutasteride

Brand Name : DUTASTERIDE ACCORD

Dosage Form : Soft Capsules

Dosage Strength : 0.5 mg

Packaging : 30 UNITS 0.5 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

Glaxo Group Ltd,

United Kingdom
26th North American ISSX
Not Confirmed
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Glaxo Group Ltd,

United Kingdom
arrow
26th North American ISSX
Not Confirmed

dutasteride

Brand Name : Avolve

Dosage Form : SOFT CAPSULE

Dosage Strength : 0.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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07

Glaxo Group Ltd,

United Kingdom
26th North American ISSX
Not Confirmed
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Glaxo Group Ltd,

United Kingdom
arrow
26th North American ISSX
Not Confirmed

dutasteride

Brand Name : Duagen

Dosage Form : SOFT CAPSULE

Dosage Strength : 0.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

GLAXOSMITHKLINE SpA

United Kingdom
26th North American ISSX
Not Confirmed
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GLAXOSMITHKLINE SpA

United Kingdom
arrow
26th North American ISSX
Not Confirmed

Dutasteride

Brand Name : Duagen

Dosage Form : Dutasteride 0.5Mg 30 Joined' Oral Use

Dosage Strength : 30 cps 0.5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

GlaxoSmithKline AG

United Kingdom
26th North American ISSX
Not Confirmed
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GlaxoSmithKline AG

United Kingdom
arrow
26th North American ISSX
Not Confirmed

Dutasteridum

Brand Name : Avodart

Dosage Form : Caps

Dosage Strength : 0.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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10

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride; Tamsulosin hydrochloride

Brand Name : Dutasteride Tamsulosin Sandoz eco

Dosage Form : Caps

Dosage Strength : 0.5/0.4mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Canada

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01

APOTEX INC

Canada
26th North American ISSX
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APOTEX INC

Canada
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26th North American ISSX
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DUTASTERIDE

Brand Name : APO-DUTASTERIDE

Dosage Form : CAPSULE

Dosage Strength : 0.5MG

Packaging : 30/100

Approval Date :

Application Number : 2404206

Regulatory Info : Prescription

Registration Country : Canada

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02

26th North American ISSX
Not Confirmed
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26th North American ISSX
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DUTASTERIDE

Brand Name : MED-DUTASTERIDE

Dosage Form : CAPSULE

Dosage Strength : 0.5MG

Packaging : 30/90

Approval Date :

Application Number : 2416298

Regulatory Info : Prescription

Registration Country : Canada

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GLAXOSMITHKLINE INC

United Kingdom
26th North American ISSX
Not Confirmed
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GLAXOSMITHKLINE INC

United Kingdom
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26th North American ISSX
Not Confirmed

DUTASTERIDE

Brand Name : AVODART

Dosage Form : CAPSULE

Dosage Strength : 0.5MG

Packaging : 30

Approval Date :

Application Number : 2247813

Regulatory Info : Prescription

Registration Country : Canada

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GLAXOSMITHKLINE INC

United Kingdom
26th North American ISSX
Not Confirmed
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GLAXOSMITHKLINE INC

United Kingdom
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26th North American ISSX
Not Confirmed

DUTASTERIDE

Brand Name : JALYN

Dosage Form : CAPSULE (IMMEDIATE AND EXTENDED RELEASE)

Dosage Strength : 0.5MG

Packaging : Jul-30

Approval Date :

Application Number : 2372010

Regulatory Info : Prescription

Registration Country : Canada

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05

26th North American ISSX
Not Confirmed
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26th North American ISSX
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DUTASTERIDE

Brand Name : JAMP DUTASTERIDE

Dosage Form : CAPSULE

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number : 2484870

Regulatory Info : Prescription

Registration Country : Canada

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06

26th North American ISSX
Not Confirmed
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26th North American ISSX
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DUTASTERIDE

Brand Name : MINT-DUTASTERIDE

Dosage Form : CAPSULE

Dosage Strength : 0.5MG

Packaging : 10/30/90

Approval Date :

Application Number : 2428873

Regulatory Info : Prescription

Registration Country : Canada

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07

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

DUTASTERIDE

Brand Name : DUTASTERIDE

Dosage Form : CAPSULE

Dosage Strength : 0.5MG

Packaging : 30/100

Approval Date :

Application Number : 2421712

Regulatory Info : Prescription

Registration Country : Canada

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08

26th North American ISSX
Not Confirmed
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26th North American ISSX
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DUTASTERIDE

Brand Name : SANDOZ DUTASTERIDE

Dosage Form : CAPSULE

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number : 2424444

Regulatory Info : Prescription

Registration Country : Canada

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09

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

DUTASTERIDE

Brand Name : DUTASTERIDE

Dosage Form : CAPSULE

Dosage Strength : 0.5MG

Packaging : 30/100

Approval Date :

Application Number : 2443058

Regulatory Info : Prescription

Registration Country : Canada

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10

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

DUTASTERIDE

Brand Name : ACT DUTASTERIDE

Dosage Form : CAPSULE

Dosage Strength : 0.5MG

Packaging : 30/100/500

Approval Date :

Application Number : 2412691

Regulatory Info : Prescription

Registration Country : Canada

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Australia

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01

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

dutasteride

Brand Name : APO-Dutasteride

Dosage Form : capsule

Dosage Strength : 500 microgram

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

dutasteride

Brand Name : APO-Dutasteride

Dosage Form : capsule

Dosage Strength : 500 microgram

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

dutasteride

Brand Name : APO-Dutasteride

Dosage Form : capsule

Dosage Strength : 500 microgram

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

dutasteride

Brand Name : APO-Dutasteride

Dosage Form : capsule

Dosage Strength : 500 microgram

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

26th North American ISSX
Not Confirmed
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26th North American ISSX
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dutasteride

Brand Name : Avodart

Dosage Form : capsule

Dosage Strength : 500 microgram

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

dutasteride

Brand Name : Avodart

Dosage Form : capsule

Dosage Strength : 500 microgram

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

dutasteride

Brand Name : Avodart

Dosage Form : capsule

Dosage Strength : 500 microgram

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

dutasteride

Brand Name : Avodart

Dosage Form : capsule

Dosage Strength : 500 microgram

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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South Africa

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01

Cipla Medpro (Pty) Ltd

South Africa
26th North American ISSX
Not Confirmed
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Cipla Medpro (Pty) Ltd

South Africa
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26th North American ISSX
Not Confirmed

Dutasteride

Brand Name : Uromax Co

Dosage Form : CAP

Dosage Strength : 0,5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride

Brand Name : Avodart

Dosage Form : CAP

Dosage Strength : 0.5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride

Brand Name : Duodart

Dosage Form : CAP

Dosage Strength : 0.5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride

Brand Name : Duozaq 0,5 mg/0,4 mg

Dosage Form : CAP

Dosage Strength : 0,5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

26th North American ISSX
Not Confirmed
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26th North American ISSX
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Dutasteride

Brand Name : Zedrast

Dosage Form : CAP

Dosage Strength : 0.5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Listed Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDouglas CDMO develops, manufactures, and packs various dosage forms, and provides regulatory support for international distribution.

Flag New Zealand
Digital Content Digital Content

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

Douglas CDMO

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDouglas CDMO develops, manufactures, and packs various dosage forms, and provides regulatory support for international distribution.

Flag New Zealand
Digital Content Digital Content

Packaging :

Regulatory Info : Generic

Dutasteride

Dosage : TABLET

Dosage Strength : 0.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : New Zealand

Douglas CDMO

02

Olpha

Latvia
  • fda
  • EDQM
  • WHO-GMP

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

Flag Latvia
Digital Content Digital Content

Regulatory Info :

Registration Country : Latvia

Dutasteride; Tamsulosin Hydrochloride

Brand Name : Dutasteride/Tamsulosin...

Dosage Form : Hard Capsule

Dosage Strength : 0.5MG; 0.4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

Olpha

02

Olpha

Latvia
  • fda
  • EDQM
  • WHO-GMP

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

Flag Latvia
Digital Content Digital Content

Packaging :

Regulatory Info :

Dutasteride; Tamsulosin Hydrochloride

Dosage : Hard Capsule

Dosage Strength : 0.5MG; 0.4MG

Brand Name : Dutasteride/Tamsulosin...

Approval Date :

Application Number :

Registration Country : Latvia

Olpha

03

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

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

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Dutasteride

Dosage : Soft Gel Capsule

Dosage Strength : 0.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Strides Pharma Science

04

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride

Brand Name :

Dosage Form : Soft Gel

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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04

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride

Dosage : Soft Gel

Dosage Strength : 0.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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05

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride

Brand Name :

Dosage Form : Pellets

Dosage Strength : 0.7%W/W

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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05

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride

Dosage : Pellets

Dosage Strength : 0.7%W/W

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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06

CHEMO

Spain
26th North American ISSX
Not Confirmed
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CHEMO

Spain
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26th North American ISSX
Not Confirmed

Dutasteride

Brand Name :

Dosage Form : Soft Gelatin Capsule

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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06

CHEMO

Spain
26th North American ISSX
Not Confirmed
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CHEMO

Spain
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26th North American ISSX
Not Confirmed

Dutasteride

Dosage : Soft Gelatin Capsule

Dosage Strength : 0.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Spain

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07

26th North American ISSX
Not Confirmed
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26th North American ISSX
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Dutasteride

Brand Name :

Dosage Form : Soft Gelatin Capsule

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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07

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride

Dosage : Soft Gelatin Capsule

Dosage Strength : 30MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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08

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Tamsulosin Hydrochloride; Dutasteride

Brand Name :

Dosage Form : SR Capsule

Dosage Strength : 0.4MG; 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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08

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Tamsulosin Hydrochloride; Dutasteride

Dosage : SR Capsule

Dosage Strength : 0.4MG; 0.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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09

26th North American ISSX
Not Confirmed
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26th North American ISSX
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Dutasteride

Brand Name : RESTAD

Dosage Form : SOFT CAPSULE

Dosage Strength : 0.5MG

Packaging : 30 CAPSULES

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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09

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride

Dosage : SOFT CAPSULE

Dosage Strength : 0.5MG

Brand Name : RESTAD

Approval Date :

Application Number :

Registration Country : Turkey

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10

26th North American ISSX
Not Confirmed
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26th North American ISSX
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Dutasteride

Brand Name : XEPROST

Dosage Form : CAPSULE

Dosage Strength : 500MCG

Packaging :

Approval Date :

Application Number : 21319

Regulatory Info : Generic

Registration Country : India

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26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

Dutasteride

Dosage : CAPSULE

Dosage Strength : 500MCG

Brand Name : XEPROST

Approval Date :

Application Number : 21319

Registration Country : India

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 0.5MG

USFDA APPLICATION NUMBER - 21319

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DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG

USFDA APPLICATION NUMBER - 22460

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