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Dutasteride

Hubei Gedian Humanwell Pharmaceutical Dutasteride

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 17 USDMF, 7 CEP/COS, 7 JDMF, 5 EU WC, 24 KDMF, 19 NDC API, 28 Listed Suppliers, $ API Reference Price

43 API Suppliers
17 USDMF
7 CEP/COS
7 JDMF
5 EU WC
24 KDMF
19 NDC API
28 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

150 FDF Dossiers, 25 FDA Orange Book, 66 Europe, 16 Canada, 8 Australia, 5 South Africa, 30 Listed Dossiers

150 FDF Dossiers
25 FDA Orange Book
66 Europe
16 Canada
8 Australia
5 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

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

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DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 34 NEWS #PharmaBuzz

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2 DATA COMPILATION #PharmaFlow
34 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 60 Finished Drug Prices, 10 Annual Reports

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3 US Medicaid Prescriptions
60 Finished Drug Prices
10 Annual Reports

MARKET PLACE

25 APIs, 3 FDF Dossiers

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25 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

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4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 2 USP , 3 Others

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2 USP
3 Others

ANALYTICAL

1 BioAnalytical Methods

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1 BioAnalytical Methods

Hubei Gedian Humanwell Pharmaceutical Dutasteride

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 10,917

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

150

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

3DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

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News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

49,494,222

Annual Reports (USD Million)

6,135

Finished Drug Prices

220 RELATED EXCIPIENT COMPANIES

392EXCIPIENTS BY APPLICATIONS

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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USDMF

01

Hubei Gedian Humanwell Pharmaceutica...

China

CPHI Middle east

Not Confirmed

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

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China

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Digital Content

Dutasteride

GDUFA

DMF Review : Complete

Rev. Date : 2021-06-24

Pay. Date : 2021-04-02

DMF Number : 26803

Submission : 2013-01-09

Status : Active

Type : II

02

Hubei Gedian Humanwell Pharmaceutica...

China

CPHI Middle east

Not Confirmed

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

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China

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Dutasteride Acid

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27763

Submission : 2013-12-16

Status : Active

Type : II

03

Dr Reddys Laboratories Ltd

India

CPHI Middle east

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

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Digital Content

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

04

Catalent Pharma Solutions Llc

U.S.A

CPHI Middle east

Not Confirmed

05

Catalent France Beinheim Sa

U.S.A

CPHI Middle east

Not Confirmed

06

Cipla Ltd

India

Switzerland

CPHI Middle east

Not Confirmed

10

Sterling Spa

Italy

CPHI Middle east

Not Confirmed

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CEP/COS

01

Hubei Gedian Humanwell Pharmaceutic...

China

Antibody Engineering

Not Confirmed

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

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China

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Dutasteride, Non-micronised and micronised

Certificate Number : R0-CEP 2020-298 - Rev 01

Status : Valid

Issue Date : 2021-07-05

Type : Chemical

Substance Number : 2641

02

APITORIA PHARMA PRIVATE LIMITED Hyd...

India

Antibody Engineering

Not Confirmed

03

CIPLA LIMITED Mumbai IN

India

Italy

Antibody Engineering

Not Confirmed

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JDMF

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EU WC

01

Dr. Reddy's Laboratories

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

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Digital Content

Dutasteride (IH)

Date of Issue : 2022-06-15

Valid Till : 2025-06-16

Written Confirmation Number : WC-0034

Address of the Firm : Chemical Technical Operations-Unit II, Plot Nos. 1, 75A, 75B, 105, 110, 111 & 1...

02

Aurobindo Pharma Limited

India

Antibody Engineering

Not Confirmed

03

Hetero Drugs

India

Antibody Engineering

Not Confirmed

04

MSN Laboratories

India

Antibody Engineering

Not Confirmed

05

Swati Spentose

India

Antibody Engineering

Not Confirmed

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KDMF

01

Hubei Gedian Humanwell Pharmaceutic...

China

Antibody Engineering

Not Confirmed

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

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China

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Digital Content

Dutasteride

Registrant Name : Ace Biopharm Co., Ltd.

Registration Date : 2023-12-13

Registration Number : Su289-17-ND

Manufacturer Name : Hubei Gedian Humanwell Pharm...

Manufacturer Address : No. 25, Juxian Road, Gedian Economic Development District, E-Zhou City, Hubei Provinc...

02

Dr. Reddy's Laboratories

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

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Dutasteride

Registrant Name : Sangjin Corporation

Registration Date : 2010-12-30

Registration Number : No. 4692-3-ND

Manufacturer Name : Dr. Reddy's Laboratories Lim...

Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri V...

03

Dr. Reddy's Laboratories

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

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Dutasteride

Registrant Name : YuYu Pharmaceutical Co., Ltd.

Registration Date : 2011-09-02

Registration Number : No. 4692-3-ND(1)

Manufacturer Name : Dr. Reddy's Laboratories Lim...

Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri V...

04

Dr. Reddy's Laboratories

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

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Digital Content

Dutasteride

Registrant Name : JDW Pharmaceutical Co., Ltd.

Registration Date : 2018-08-14

Registration Number : No. 4692-3-ND(2)

Manufacturer Name : Dr. Reddy's Laboratories Lim...

Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri V...

Portfolio PDF

Product Web Link

Virtual Booth

India

Antibody Engineering

Not Confirmed

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

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NDC API

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Listed Suppliers

01

Hubei Gedian Humanwell Pharmaceutic...

China

Antibody Engineering

Not Confirmed

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

Contact Supplier

China

Virtual Booth

Digital Content

Dutasteride

About the Company : Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is a modern high-tech pharmaceutical company with a focus on the research and development, production, and sales of fertility regula...

Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is a modern high-tech pharmaceutical company with a focus on the research and development, production, and sales of fertility regulation drugs and steroidal APIs. It operates as a wholly-owned subsidiary of Humanwell Healthcare Group (Stock Code: 600079), one of the leading pharmaceutical conglomerates in China. The company operates two APIs manufacturing sites, one formulation factory, and one excipients factory, showcasing its commitment to integrating the reproductive health industry chain from raw materials and active pharmaceutical ingredients (APIs) to finished dosage forms.

02

LGM Pharma

U.S.A

Antibody Engineering

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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U.S.A

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Digital Content

Dutasteride

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

03

Metrochem API Private Limited

India

Antibody Engineering

Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Contact Supplier

India

Virtual Booth

Digital Content

Dutasteride

About the Company :

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer

04

Dr. Reddy's Laboratories

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

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Digital Content

Dutasteride

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale

05

Gonane Pharma

India

Antibody Engineering

Not Confirmed

Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

Contact Supplier

India

Virtual Booth

Digital Content

Dutasteride

About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.

06

Jai Radhe Sales

India

Antibody Engineering

Not Confirmed

Jai Radhe Sales is your partner for all your sourcing needs.

Contact Supplier

India

Virtual Booth

Digital Content

Dutasteride

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.

07

HRV Global Life Sciences

India

Antibody Engineering

Not Confirmed

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

Virtual Booth

Digital Content

Dutasteride

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

08

Aspen Biopharma Labs

India

Antibody Engineering

Not Confirmed

09

Aspire Lifesciences Pvt Ltd

India

Antibody Engineering

Not Confirmed

10

Hetero Drugs

India

Antibody Engineering

Not Confirmed

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

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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

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

FDF Dossiers

01

Sanofi

France

CPHI Middle east

Not Confirmed

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

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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

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02

Sanofi

France

CPHI Middle east

Not Confirmed

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

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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

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Product Web Link

03

Sanofi

France

CPHI Middle east

Not Confirmed

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

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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

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04

Douglas CDMO

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

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Regulatory Info : Generic

Registration Country : New Zealand

Dutasteride

Brand Name :

Dosage Form : TABLET

Dosage Strength : 0.5MG

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Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : New Zealand

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Corporate PDF

05

Olpha

Latvia

CPHI Middle east

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

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Digital Content

Regulatory Info :

Registration Country : Latvia

Dutasteride; Tamsulosin Hydrochloride

Brand Name : Dutasteride/Tamsulosin Olainfarm

Dosage Form : Hard Capsule

Dosage Strength : 0.5MG; 0.4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

06

Strides Pharma Science

India

CPHI Middle east

Not Confirmed

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

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India

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Digital Content

Regulatory Info : RX

Registration Country : USA

DUTASTERIDE

Brand Name : DUTASTERIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG

Packaging :

Approval Date : 2015-11-20

Application Number : 204262

Regulatory Info : RX

Registration Country : USA

07

Strides Pharma Science

India

CPHI Middle east

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 : DISCN

Registration Country : USA

DUTASTERIDE

Brand Name : DUTASTERIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.5MG

Packaging :

Approval Date : 2018-06-22

Application Number : 208227

Regulatory Info : DISCN

Registration Country : USA

08

Strides Pharma Science

India

CPHI Middle east

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

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Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

09

Towa Pharmaceutical

Japan

CPHI Middle east

Not Confirmed

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

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Japan

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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

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Application Number :

Regulatory Info :

Registration Country : Italy

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10

Spirig Healthcare

Switzerland

CPHI Middle east

Not Confirmed

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FDA Orange Book

01

STRIDES PHARMA

India

CPHI Middle east

Not Confirmed

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

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India

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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

02

STRIDES PHARMA

India

CPHI Middle east

Not Confirmed

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

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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 :

03

ACTAVIS LABS FL INC

Ireland

CPHI Middle east

Not Confirmed

04

ACTAVIS LABS FL INC

Ireland

CPHI Middle east

Not Confirmed

05

ASCENT PHARMS INC

India

CPHI Middle east

Not Confirmed

06

AMNEAL PHARMS

U.S.A

U.S.A

CPHI Middle east

Not Confirmed

10

WAYLIS THERAP

U.S.A

CPHI Middle east

Not Confirmed

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Europe

01

Helvepharm AG

France

CPHI Middle east

Not Confirmed

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

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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

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Product Web Link

02

Helvepharm AG

France

CPHI Middle east

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

CPHI Middle east

Not Confirmed

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

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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

CPHI Middle east

Not Confirmed

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

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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

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Product Web Link

05

Glaxo Group Ltd,

United Kingdom

Czech Republic

CPHI Middle east

Not Confirmed

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Canada

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Australia

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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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DATA COMPILATION #PharmaFlow

Top drugs and pharmaceutical companies of 2019 by revenues

Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues. Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively. Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention. GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion). US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic. Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)