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ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 11 USDMF, 5 CEP/COS, 4 JDMF, 6 EU WC, 5 KDMF, 10 NDC API, 11 Listed Suppliers, $ API Reference Price

19 API Suppliers
11 USDMF
5 CEP/COS
4 JDMF
6 EU WC
5 KDMF
10 NDC API
11 Listed Suppliers
$ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

222 FDF Dossiers, 138 FDA Orange Book, 60 Europe, 12 Canada, 5 South Africa, 7 Listed Dossiers

222 FDF Dossiers
138 FDA Orange Book
60 Europe
12 Canada
5 South Africa
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET;ORAL - EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

relatedExcipients
3 Rochem International Inc
17 SPI Pharma
2 Seqens
5 DKSH
2 Jai Radhe Sales
4 Boai NKY Pharmaceuticals Ltd
12 Gangwal Healthcare
8 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 ACG Worldwide
6 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
23 BASF
1 Clariant
12 Corel Pharma Chem
6 DFE Pharma
2 Finar
11 Gangwal Chemicals
7 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
39 Kerry
5 Kima Chemical
6 Lonza Capsugel
17 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
3 Novo Excipients
2 Pharmatrans-Sanaq
7 Pluviaendo
3 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
23 Roquette
13 Seppic
7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
4 The Dow Chemical Company
2 Ulanqab Kema New Material
1 Valens Pharmachem
3 Vasa Pharmachem
1 Vertellus

EXCIPIENTS BY APPLICATIONS

96 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 43 Direct Compression, 36 Controlled & Modified Release, 31 Solubilizers, 30 Thickeners and Stabilizers, 27 Granulation, 23 Disintegrants & Superdisintegrants, 21 Film Formers & Plasticizers, 21 Co-Processed Excipients, 21 Taste Masking, 19 Parenteral, 18 Lubricants & Glidants, 16 Topical, 16 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 8 Rheology Modifiers, 8 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 1 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 53 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
53 Finished Drug Prices

MARKET PLACE

3 APIs

marketPlace
3 APIs

PATENTS & EXCLUSIVITIES

18 Health Canada Patents

patents
18 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP , 2 Others

otherSolutions
1 USP
2 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 4,462

MARKET PLACE

API

FDF

3INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

222

FDF Dossiers

138

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS 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

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

64,735,063

Annual Reports (USD Million)

Finished Drug Prices

291 RELATED EXCIPIENT COMPANIES

518EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 91374-20-8, Ropinirole hcl, Requip, 4-(2-(dipropylamino)ethyl)indolin-2-one hydrochloride, Skf 101468 hydrochloride, Requip xl

Molecular Formula

C₁₆H₂₅ClN₂O

Molecular Weight

296.83 g/mol

InChI Key

XDXHAEQXIBQUEZ-UHFFFAOYSA-N

FDA UNII

D7ZD41RZI9

Ropinirole Hydrochloride is the hydrochloride salt form of ropinirole, a non-ergot dopamine agonist with antiparkinsonian property. Acting as a substitute for dopamine, ropinirole hydrochloride binds to and activates dopamine D2 and D3 receptors within the caudate putamen in the brain, thereby improving motor function.

1 2D Structure

Ropinirole Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-[2-(dipropylamino)ethyl]-1,3-dihydroindol-2-one;hydrochloride

2.1.2 InChI

InChI=1S/C16H24N2O.ClH/c1-3-9-18(10-4-2)11-8-13-6-5-7-15-14(13)12-16(19)17-15;/h5-7H,3-4,8-12H2,1-2H3,(H,17,19);1H

2.1.3 InChI Key

XDXHAEQXIBQUEZ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCCN(CCC)CCC1=C2CC(=O)NC2=CC=C1.Cl

2.2 Other Identifiers

2.2.1 UNII

D7ZD41RZI9

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 4-(2-(di-n-propylamino)ethyl)-2(3h)-indolone

2. Requip

3. Ropinirol

4. Ropinirole

5. Sk And F 101468

6. Sk And F-101,468

7. Skf 101468

2.3.2 Depositor-Supplied Synonyms

1. 91374-20-8

2. Ropinirole Hcl

3. Requip

4. 4-(2-(dipropylamino)ethyl)indolin-2-one Hydrochloride

5. Skf 101468 Hydrochloride

6. Requip Xl

7. Sk&f 101468-a

8. Ropinirole (hydrochloride)

9. 4-[2-(dipropylamino)ethyl]-1,3-dihydroindol-2-one;hydrochloride

10. D7zd41rzi9

11. Ropinirole (as Hydrochloride)

12. 4-(2-(dipropylamino)ethyl)-2-indolinone Monohydrochloride

13. 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2h-indol-2-one Hydrochloride

14. Sk&f-101468a

15. Sk&f-101468-a

16. Ropinirolhydrochloride

17. Ropinirolehydrochloride

18. Ropinirole Hydrochloride [usan]

19. Sr-01000076215

20. Ropinirole Hydrochloride [usan:usp]

21. Unii-d7zd41rzi9

22. C16h24n2o.hcl

23. Adartrel

24. Repreve

25. Requi

26. Requip Cr

27. Requip Lp

28. Requip Pr

29. Requip Xr

30. Skf-101468a

31. Mfcd01754173

32. Requip (tn)

33. 1,3-dihydro-4-(2-(dipropylamino)ethyl)-2h-indol-2-one Monohydrochloride

34. Jzp-7

35. Schembl40760

36. Mls003899234

37. Chebi:8889

38. Chembl1200411

39. Hy-b0623a

40. Dtxsid50238533

41. Nvd-434

42. 4-[2-(dipropylamino)ethyl]-1,3-dihydroindol-2-one Hydrochloride

43. Act02690

44. Bcp02130

45. Ex-a4943

46. Ropinirole For Peak Identification 1

47. Ropinirole For Peak Identification 2

48. Ropinirole For Peak Identification 3

49. Ropinirole Hydrochloride (jan/usp)

50. Tox21_501101

51. Ac-735

52. Ac-736

53. Np-201

54. Ropinirole Hydrochloride [mi]

55. S3189

56. Ropinirole Hydrochloride [jan]

57. Akos015844988

58. Bs-1020

59. Ccg-213346

60. Hp-3000

61. Lp01101

62. 2(h)-indol-2-one, 4-(2-(dipropylamino)ethyl)-1,3-dihydro-, Monohydrochloride

63. Ropinirole Hydrochloride [mart.]

64. Ropinirole Hydrochloride [vandf]

65. Ncgc00094373-01

66. Ncgc00261786-01

67. Ropinirole Hydrochloride [usp-rs]

68. Ropinirole Hydrochloride [who-dd]

69. Smr001456484

70. Eu-0101101

71. Ft-0642200

72. Sw199044-2

73. Ropinirole Hydrochloride [orange Book]

74. D00784

75. R 4152

76. Ropinirole Hydrochloride [ep Monograph]

77. Ropinirole Hydrochloride [usp Monograph]

78. 374r208

79. A843815

80. Ropinirole Hydrochloride, Powder, >=98% (hplc)

81. Sr-01000076215-2

82. Sr-01000076215-5

83. 4-(2-dipropylamino-ethyl)-1,3-dihydro-indol-2-one

84. Q27276228

85. 4-(2-di-n-propylaminoethyl)-2(3h)indolone Hydrochloride

86. Z1695926158

87. 4-(2-di-n-propylaminoethyl)-2(3h)-indolone Hydrochloride

88. 4-[2-(dipropylamino)ethyl]-1,3-dihy Dro-2h-indol-2-one Hydrochloride

89. 4-[2-(dipropylamino)ethyl]-2,3-dihydro-1h-indol-2-one Hydrochloride

90. Ropinirole Hydrochloride, Europepharmacopoeia (ep) Reference Standard

91. 2h-indol-2-one, 4-(2-(dipropylamino)ethyl)-1,3-dihydro-, Monohydrochloride

92. 4-(2-(dipropylamino)ethyl)-1,3-dihydro-2h-indol-2-one Monohydrochloride

93. Ropinirole For Peak Identification 1, Europepharmacopoeia (ep) Reference Standard

94. Ropinirole For Peak Identification 2, Europepharmacopoeia (ep) Reference Standard

95. Ropinirole Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

96. Ropinirole Hydrochloride, United States Pharmacopeia (usp) Reference Standard

97. Skf 101468; 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2h-indol-2-one Hydrochloride

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₂₅ClN₂O
Molecular Weight	296.83 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	7
Exact Mass	296.1655411 g/mol
Monoisotopic Mass	296.1655411 g/mol
Topological Polar Surface Area	32.3 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	287
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Ropinirole hydrochloride
Drug Label	Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular w...
Active Ingredient	Ropinirole hydrochloride
Dosage Form	Tablet, extended release; Tablet
Route	Oral
Strength	eq 4mg base; eq 5mg base; eq 0.5mg base; eq 2mg base; eq 0.25mg base; eq 6mg base; eq 1mg base; eq 12mg base; eq 3mg base; eq 8mg base
Market Status	Prescription
Company	Mylan Pharms; Wockhardt; Alembic; Teva; Apotex; Sandoz; Prinston; Roxane; Watson Labs; Glenmark Generics; Actavis Elizabeth; Zydus Pharms Usa; Dr Reddys Labs; Orchid Hlthcare; Mylan

2 of 2
Drug Name	Ropinirole hydrochloride
Drug Label	Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an molecular formula of C16H24N2OHCl. The molecular w...
Active Ingredient	Ropinirole hydrochloride
Dosage Form	Tablet, extended release; Tablet
Route	Oral
Strength	eq 4mg base; eq 5mg base; eq 0.5mg base; eq 2mg base; eq 0.25mg base; eq 6mg base; eq 1mg base; eq 12mg base; eq 3mg base; eq 8mg base
Market Status	Prescription
Company	Mylan Pharms; Wockhardt; Alembic; Teva; Apotex; Sandoz; Prinston; Roxane; Watson Labs; Glenmark Generics; Actavis Elizabeth; Zydus Pharms Usa; Dr Reddys Labs; Orchid Hlthcare; Mylan

4.2 Drug Indication

Induction of vomiting in dogs.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antiparkinson Agents

Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)

Dopamine Agonists

Drugs that bind to and activate dopamine receptors. (See all compounds classified as Dopamine Agonists.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Nonergot Dopamine Agonist [EPC]; Dopamine Agonists [MoA]

5.3 ATC Code

QN04BC04

API SUPPLIERS

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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DOSAGE - TABLET;ORAL - EQ 0.25MG BASE **Feder...DOSAGE - TABLET;ORAL - EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**