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Plaquenil

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ACTIVE PHARMA INGREDIENTS

48 API Suppliers, 23 USDMF, 8 CEP/COS, 2 JDMF, 14 EU WC, 7 KDMF, 19 NDC API, 31 Listed Suppliers, $ API Reference Price

48 API Suppliers
23 USDMF
8 CEP/COS
2 JDMF
14 EU WC
7 KDMF
19 NDC API
31 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

42 Drugs in Development

42 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

67 FDF Dossiers, 24 FDA Orange Book, 7 Europe, 6 Canada, 4 Australia, 26 Listed Dossiers

67 FDF Dossiers
24 FDA Orange Book
7 Europe
6 Canada
4 Australia
26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG, TABLET;ORAL - 300MG, TABLET;ORAL - 200MG

drugProductComposition
TABLET;ORAL - 200MG
TABLET;ORAL - 300MG
TABLET;ORAL - 200MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 4 DKSH, 2 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 25 BASF, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

75 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 37 Direct Compression, 32 Controlled & Modified Release, 31 Disintegrants & Superdisintegrants, 25 Granulation, 24 Thickeners and Stabilizers, 24 Solubilizers, 17 Lubricants & Glidants, 16 Co-Processed Excipients, 14 Topical, 13 Parenteral, 13 Film Formers & Plasticizers, 12 Taste Masking, 7 Emulsifying Agents, 7 Chewable & Orodispersible Aids, 7 API Stability Enhancers, 5 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

9 DATA COMPILATION #PharmaFlow, 394 NEWS #PharmaBuzz

media
9 DATA COMPILATION #PharmaFlow
394 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 10 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
10 Finished Drug Prices

MARKET PLACE

63 APIs, 17 FDF Dossiers

marketPlace
63 APIs
17 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM , 1 USP , 7 Others

otherSolutions
1 EDQM
1 USP
7 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 141

MARKET PLACE

API

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

42DRUGS 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

394

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

173,687,529

Annual Reports (USD Million)

Finished Drug Prices

258 RELATED EXCIPIENT COMPANIES

431EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 747-36-4, Hydroxychloroquine sulphate, Ercoquin, Plaquenil, 2-((4-((7-chloroquinolin-4-yl)amino)pentyl)(ethyl)amino)ethanol sulfate, Quensyl

Molecular Formula

C₁₈H₂₈ClN₃O₅S

Molecular Weight

434.0 g/mol

InChI Key

JCBIVZZPXRZKTI-UHFFFAOYSA-N

FDA UNII

8Q2869CNVH

A chemotherapeutic agent that acts against erythrocytic forms of malarial parasites. Hydroxychloroquine appears to concentrate in food vacuoles of affected protozoa. It inhibits plasmodial heme polymerase. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p970)

1 2D Structure

Hydroxychloroquine Sulphate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[4-[(7-chloroquinolin-4-yl)amino]pentyl-ethylamino]ethanol;sulfuric acid

2.1.2 InChI

InChI=1S/C18H26ClN3O.H2O4S/c1-3-22(11-12-23)10-4-5-14(2)21-17-8-9-20-18-13-15(19)6-7-16(17)18;1-5(2,3)4/h6-9,13-14,23H,3-5,10-12H2,1-2H3,(H,20,21);(H2,1,2,3,4)

2.1.3 InChI Key

JCBIVZZPXRZKTI-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCN(CCCC(C)NC1=C2C=CC(=CC2=NC=C1)Cl)CCO.OS(=O)(=O)O

2.2 Other Identifiers

2.2.1 UNII

8Q2869CNVH

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Hydroxychlorochin

2. Hydroxychloroquine

3. Hydroxychloroquine Sulfate (1:1) Salt

4. Oxychlorochin

5. Oxychloroquine

6. Plaquenil

2.3.2 Depositor-Supplied Synonyms

1. 747-36-4

2. Hydroxychloroquine Sulphate

3. Ercoquin

4. Plaquenil

5. 2-((4-((7-chloroquinolin-4-yl)amino)pentyl)(ethyl)amino)ethanol Sulfate

6. Quensyl

7. Oxiklorin

8. Tcmdc-123987

9. Hcq Sulfate

10. Plaquenil Sulfate

11. Nsc 4375

12. Hydroxychloroquine (sulfate)

13. Oxichlorochine Sulfate

14. Nsc-4375

15. 8q2869cnvh

16. 2-[4-[(7-chloroquinolin-4-yl)amino]pentyl-ethylamino]ethanol;sulfuric Acid

17. 2-({4-[(7-chloroquinolin-4-yl)amino]pentyl}(ethyl)amino)ethan-1-ol; Sulfuric Acid

18. Plaquinol

19. Toremonil

20. 2-((4-((7-chloroquinolin-4-yl)amino)pentyl)(ethyl)amino)ethan-1-ol Sulfate

21. Dsstox_cid_27788

22. Dsstox_rid_82563

23. N4-(7-chloro-4-quinolyl)-n1-ethyl-n1-(2-hydroxyethyl)-1,4-pentanediamine Sulfate

24. Dsstox_gsid_47811

25. 2-((4-(7-chloroquinolin-4-ylamino)pentyl)(ethyl)amino)ethanol Sulfate

26. 2-((4-((7-chloroquinolin-4-yl)amino)-pentyl)(ethyl)amino)ethanol Sulfate

27. Cas-747-36-4

28. Hydroxychloroquine Sulfate [usp]

29. Ethanol, 2-((4-((7-chloro-4-quinolinyl)amino)pentyl)ethylamino)-, Sulfate (1:1)

30. Sr-05000001881

31. Ncgc00159483-02

32. Einecs 212-019-3

33. Unii-8q2869cnvh

34. Quinoric

35. Ai3-52706

36. Plaquenil (tn)

37. Ethanol, Monosulfate

38. Mfcd00078203

39. Ethanol, 2-[[4-[(7-chloro-4-quinolinyl)amino]pentyl]ethylamino]-, Sulfate (1:1)

40. Hydroxychlorquine Sulfate

41. 2-((4-((7-chloro-4-quinolinyl)amino)pentyl)ethylamino)ethanol Sulfate (1:1) (salt)

42. 2-((4-((7-chloro-4-quinolyl)amino)pentyl)ethylamino)ethanol Sulfate (1:1) (salt)

43. Chembl1690

44. Ethanol, 2-((4-((7-chloro-4-quinolyl)amino)pentyl)ethylamino)-, Sulfate (1:1) (salt)

45. Schembl41114

46. Spectrum1503978

47. 747-36-4 (sulfate)

48. Dtxsid1047811

49. Hydroxychloroquine Sulfate ,(s)

50. Hydroxychloroquine Sulfate- Bio-x

51. Ethanol, Sulfate (1:1) (salt)

52. Hms1922o12

53. Hms2093o05

54. Hms3713j22

55. Pharmakon1600-01503978

56. Bcp12823

57. Hy-b1370

58. Tox21_111707

59. Bdbm50247975

60. Ccg-39154

61. Nsc758663

62. S4430

63. Hydroxychloroquine Sulfate (jan/usp)

64. Akos015897337

65. Tox21_111707_1

66. Cs-8017

67. Hydroxychloroquine Sulfate [mi]

68. Ks-5311

69. Nsc-758663

70. Sb19140

71. (+-)-2-((4-((7-chloro-4-quinolyl)amino)pentyl)ethylamino)ethanol Sulfate (1:1) (salt)

72. 7-chloro-4-[4-[n-ethyl-n-(2-hydroxyethyl)amino]-1-methylbutylamino]quinoline Sulfate

73. Hydroxychloroquine Sulfate [jan]

74. Ncgc00095090-01

75. Ncgc00095090-02

76. Ncgc00159483-04

77. Bh164525

78. Ethanol, 2-((4-((7-chloro-4-quinolinyl)amino)pentyl)ethyl)amino-, (+-)-, Sulfate (1:1) Salt

79. Hydroxychloroquine Sulfate [mart.]

80. Hydroxychloroquine Sulfate [vandf]

81. Hydroxychloroquine Sulfate [usp-rs]

82. Hydroxychloroquine Sulfate [who-dd]

83. Db-055904

84. Ft-0603511

85. Ft-0669460

86. H1306

87. Hydroxycloroquine Sulfate, Analytical Standard

88. D02114

89. H10433

90. Hydroxychloroquine Sulfate [orange Book]

91. Hydroxychloroquine Sulfate [ep Monograph]

92. 747h364

93. A838213

94. Hydroxychloroquine Sulfate [usp Monograph]

95. Hydroxychloroquine Sulfate, >=98% (hplc), Powder

96. Sr-05000001881-1

97. Sr-05000001881-2

98. W-104413

99. Q27270879

100. Z1551900864

101. Hydroxychloroquine Sulphate 1.0 Mg/ml In Methanol (as Free Base)

102. 2-[[4-[(7-chloro-4-quinolinyl)amino]pentyl]ethylamino]ethanol Sulfate

103. Hydroxychloroquine Sulfate, Pharmaceutical Secondary Standard; Certified Reference Material

104. Hydroxychloroquine Sulfate, United States Pharmacopeia (usp) Reference Standard

105. (+/-)-2-((4-((7-chloro-4-quinolyl)amino)pentyl)ethylamino)ethanol Sulfate (1:1) (salt)

106. (+/-)-2-((4-((7-chloro-4-quinolyl)amino)pentyl)ethylamino)ethanol Sulphate (1:1) (salt)

107. 14480-75-2

108. Ethanol, 2-((4-((7-chloro-4-quinolinyl)amino)pentyl)ethyl)amino-, (+/-)-, Sulfate (1:1) Salt

109. Ethanol, 2-((4-((7-chloro-4-quinolinyl)amino)pentyl)ethyl)amino-, (+/-)-, Sulphate (1:1) Salt

2.4 Create Date

2005-03-26

3 Chemical and Physical Properties

Molecular Formula	C₁₈H₂₈ClN₃O₅S
Molecular Weight	434.0 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	9
Exact Mass	433.1438199 g/mol
Monoisotopic Mass	433.1438199 g/mol
Topological Polar Surface Area	131 Å²
Heavy Atom Count	28
Formal Charge	0
Complexity	413
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
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	Hydroxychloroquine sulfate
Drug Label	Hydroxychloroquine sulfate, USP is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1). Hydroxychloroquine sulfate, USP has the fo...
Active Ingredient	Hydroxychloroquine sulfate
Dosage Form	Tablet
Route	Oral
Strength	200mg
Market Status	Prescription
Company	Sandoz; Hikma Pharms; Teva Pharms; Ipca Labs; Zydus Pharms Usa; Mylan

2 of 2
Drug Name	Hydroxychloroquine sulfate
Drug Label	Hydroxychloroquine sulfate, USP is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1). Hydroxychloroquine sulfate, USP has the fo...
Active Ingredient	Hydroxychloroquine sulfate
Dosage Form	Tablet
Route	Oral
Strength	200mg
Market Status	Prescription
Company	Sandoz; Hikma Pharms; Teva Pharms; Ipca Labs; Zydus Pharms Usa; Mylan

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antimalarials

Agents used in the treatment of malaria. They are usually classified on the basis of their action against plasmodia at different stages in their life cycle in the human. (From AMA, Drug Evaluations Annual, 1992, p1585) (See all compounds classified as Antimalarials.)

Enzyme Inhibitors

Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)

Antirheumatic Agents

Drugs that are used to treat RHEUMATOID ARTHRITIS. (See all compounds classified as Antirheumatic Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Antirheumatic Agent [EPC]; Antimalarial [EPC]

API SUPPLIERS

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USDMF

01

Euroapi Hungary Ltd

France

CPhI Worldwide, Milan

Booth #5A113

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

Contact Supplier

France

Virtual Booth

Digital Content

Hydroxychloroquine Sulfate

GDUFA

DMF Review : Complete

Rev. Date : 2022-02-16

Pay. Date : 2022-02-11

DMF Number : 20692

Submission : 2007-07-17

Status : Active

Type : II

02

Fermion Oy

Finland

CPhI Worldwide, Milan

Booth #2B26

With Fermion, start the journey of your innovative API.

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Finland

Virtual Booth

Digital Content

Hydroxychloroquine Sulphate

GDUFA

DMF Review : Complete

Rev. Date : 2016-02-26

Pay. Date : 2016-01-21

DMF Number : 30014

Submission : 2015-11-24

Status : Active

Type : II

03

Sci Pharmtech Inc

Taiwan

CPhI Worldwide, Milan

Booth #3A86

SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

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Taiwan

Virtual Booth

Digital Content

Hydroxychloroquine Sulfate

GDUFA

DMF Review : Complete

Rev. Date : 2015-09-11

Pay. Date : 2015-09-08

DMF Number : 8619

Submission : 1990-06-27

Status : Active

Type : II

04

Abbott Laboratories

U.S.A

ASC 2024

Not Confirmed

05

Alkaloida Chemical Co Ltd

Hungary

ASC 2024

Not Confirmed

06

Curia New York Inc

U.S.A

ASC 2024

Not Confirmed

07

Ipca Laboratories Ltd

India

ASC 2024

Not Confirmed

08

Shanghai Zhongxi Pharmaceutical Co L...

China

ASC 2024

Not Confirmed

09

Wuhan Wuyao Pharmaceutical Co Ltd

China

ASC 2024

Not Confirmed

10

Zydus Lifesciences Ltd

India

ASC 2024

Not Confirmed

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JDMF

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KDMF

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NDC API

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API Reference Price

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HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666204200,"product":"(RE-IMPORT)HYDROXYCHLOROQUINE SULFATE USP43 (BATCH NOS: HL\/HC20050014, HL\/HC20050015)","address":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta","city":"HYDERABAD","supplier":"PROFECT FOR INVESTMENTS","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"130","totalValueFC":"65131","currency":"USD","unitRateINR":"10718.5","date":"20-Oct-2022","totalValueINR":"5359250","totalValueInUsd":"65131","indian_port":"HYDERABAD AIR","hs_no":"29334900","bill_no":"2975433","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1667586600,"product":"HYDROXYCHLOROQUINE SULFATE EP\/BP\/IP\/USP\/PH.EUR","address":"CORPORATE HOUSE, NR. 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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723833000,"product":"(RE-IMPORT REJECTED GOODS) HYDROXYCHLOROQUINE SULPHATE USP","address":"48, KANDIVLI INDUSTRIAL ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"TEKRADE LTD","supplierCountry":"INDIA","foreign_port":"VANCOUVER","customer":"IPCA LABORATORIES","customerCountry":"INDIA","quantity":"3339.04","actualQuantity":"3339.04","unit":"KGS","unitRateFc":"185","totalValueFC":"636546.4","currency":"USD","unitRateINR":"15990.4","date":"17-Aug-2024","totalValueINR":"53392582.62","totalValueInUsd":"636546.4","indian_port":"JNPT","hs_no":"29334900","bill_no":"5115957","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"VANCOUVER","supplierAddress":"17-19 CHATHAM ROAD SOUTH TSIM SHA TSUI KOWLOON, HONG KONGSDNF Hong Kong","customerAddress":"48, KANDIVLI INDUSTRIAL ESTATE,"}]

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

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 200MG

USFDA APPLICATION NUMBER - 214581

DOSAGE - TABLET;ORAL - 300MG

USFDA APPLICATION NUMBER - 214581

DOSAGE - TABLET;ORAL - 200MG

USFDA APPLICATION NUMBER - 9768

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

48 API Suppliers

23 USDMF

8 CEP/COS

2 JDMF

14 EU WC

7 KDMF

19 NDC API

31 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

42 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

67 FDF Dossiers

24 FDA Orange Book

7 Europe

6 Canada

4 Australia

26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG

TABLET;ORAL - 300MG

TABLET;ORAL - 200MG

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6 Actylis

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25 BASF

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EXCIPIENTS BY APPLICATIONS

75 Fillers, Diluents & Binders

54 Coating Systems & Additives

37 Direct Compression

32 Controlled & Modified Release

31 Disintegrants & Superdisintegrants

25 Granulation

24 Thickeners and Stabilizers

24 Solubilizers

17 Lubricants & Glidants