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    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
    Hydroxychloroquine Sulphate
    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 Weight 434.0 g/mol
    Molecular Formula C18H28ClN3O5S
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count9
    Exact Mass433.1438199 g/mol
    Monoisotopic Mass433.1438199 g/mol
    Topological Polar Surface Area131 Ų
    Heavy Atom Count28
    Formal Charge0
    Complexity413
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameHydroxychloroquine sulfate
    Drug LabelHydroxychloroquine 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 IngredientHydroxychloroquine sulfate
    Dosage FormTablet
    RouteOral
    Strength200mg
    Market StatusPrescription
    CompanySandoz; Hikma Pharms; Teva Pharms; Ipca Labs; Zydus Pharms Usa; Mylan

    2 of 2  
    Drug NameHydroxychloroquine sulfate
    Drug LabelHydroxychloroquine 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 IngredientHydroxychloroquine sulfate
    Dosage FormTablet
    RouteOral
    Strength200mg
    Market StatusPrescription
    CompanySandoz; 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 Reference Price

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HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1650306600,"product":"HYDROXYCHLOROQUINE SULFATE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"HELSINKI (HELSINGFORS)","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2682.00","actualQuantity":"2682","unit":"KGS","unitRateFc":"240","totalValueFC":"655230.9","currency":"USD","unitRateINR":"18432.7","date":"19-Apr-2022","totalValueINR":"49436467","totalValueInUsd":"655230.9","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29334900","bill_no":"1001561","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI (HELSINGFORS)","supplierAddress":"KOIVU-MANKKAAN TIE 6 A P.O BOX 28 FI-02101 ESPOO FINLAND","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1650652200,"product":"CHEMICAL : HYDROXYCHLOROQUINE SULFATE USP","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"918.00","actualQuantity":"918","unit":"KGS","unitRateFc":"230","totalValueFC":"215900.4","currency":"USD","unitRateINR":"17744.5","date":"23-Apr-2022","totalValueINR":"16289451","totalValueInUsd":"215900.4","indian_port":"AHMEDABAD AIR","hs_no":"29334900","bill_no":"8388928","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659292200,"product":"CHEMICAL : HYDROXYCHLOROQUINE SULFATE PH.EUR","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"612.00","actualQuantity":"612","unit":"KGS","unitRateFc":"210","totalValueFC":"130753.6","currency":"USD","unitRateINR":"16999.5","date":"01-Aug-2022","totalValueINR":"10403694","totalValueInUsd":"130753.6","indian_port":"AHMEDABAD AIR","hs_no":"29334900","bill_no":"9808009","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659292200,"product":"CHEMICAL : HYDROXYCHLOROQUINE SULFATE PH.EUR","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1008.00","actualQuantity":"1008","unit":"KGS","unitRateFc":"210","totalValueFC":"215358.9","currency":"USD","unitRateINR":"16999.5","date":"01-Aug-2022","totalValueINR":"17135496","totalValueInUsd":"215358.9","indian_port":"AHMEDABAD AIR","hs_no":"29334900","bill_no":"9808009","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676658600,"product":"HYDROXYCHLOROQUINE SULFATE EP\/BP\/IP\/USP\/PH. EUR.","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1043.00","actualQuantity":"1043","unit":"KGS","unitRateFc":"180","totalValueFC":"190149.5","currency":"USD","unitRateINR":"15057","date":"18-Feb-2023","totalValueINR":"15704451","totalValueInUsd":"190149.5","indian_port":"AHMEDABAD AIR","hs_no":"29334900","bill_no":"4701375","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713378600,"product":"HYDROXYCHLOROQUINE SULFATE","address":"IRIS- 1004, KESAR GARDEN, PLOT NO.","city":"NAVI MUMBAI.","supplier":"SCI PHARMTECH","supplierCountry":"TAIWAN","foreign_port":"TAOYUAN","customer":"V-ENSURE PHARMA TECHNOLOGIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"120.00","actualQuantity":"120","unit":"KGS","unitRateFc":"225","totalValueFC":"27272.5","currency":"USD","unitRateINR":"18978.8","date":"18-Apr-2024","totalValueINR":"2277450","totalValueInUsd":"27272.5","indian_port":"Bombay Air","hs_no":"29334900","bill_no":"3072125","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAOYUAN","supplierAddress":"N\/A","customerAddress":"IRIS- 1004, KESAR GARDEN, PLOT NO."},{"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,"}]
    05-Jan-2021
    27-Dec-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 200MG

    USFDA APPLICATION NUMBER - 214581

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    DOSAGE - TABLET;ORAL - 300MG

    USFDA APPLICATION NUMBER - 214581

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    DOSAGE - TABLET;ORAL - 200MG

    USFDA APPLICATION NUMBER - 9768

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    USP

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    ABOUT THIS PAGE

    Hydroxychloroquine Sulphate Manufacturers

    A Hydroxychloroquine Sulphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxychloroquine Sulphate, including repackagers and relabelers. The FDA regulates Hydroxychloroquine Sulphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxychloroquine Sulphate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Hydroxychloroquine Sulphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Hydroxychloroquine Sulphate Suppliers

    A Hydroxychloroquine Sulphate supplier is an individual or a company that provides Hydroxychloroquine Sulphate active pharmaceutical ingredient (API) or Hydroxychloroquine Sulphate finished formulations upon request. The Hydroxychloroquine Sulphate suppliers may include Hydroxychloroquine Sulphate API manufacturers, exporters, distributors and traders.

    click here to find a list of Hydroxychloroquine Sulphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Hydroxychloroquine Sulphate USDMF

    A Hydroxychloroquine Sulphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxychloroquine Sulphate active pharmaceutical ingredient (API) in detail. Different forms of Hydroxychloroquine Sulphate DMFs exist exist since differing nations have different regulations, such as Hydroxychloroquine Sulphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Hydroxychloroquine Sulphate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxychloroquine Sulphate USDMF includes data on Hydroxychloroquine Sulphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxychloroquine Sulphate USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Hydroxychloroquine Sulphate suppliers with USDMF on PharmaCompass.

    Hydroxychloroquine Sulphate JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Hydroxychloroquine Sulphate Drug Master File in Japan (Hydroxychloroquine Sulphate JDMF) empowers Hydroxychloroquine Sulphate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Hydroxychloroquine Sulphate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydroxychloroquine Sulphate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Hydroxychloroquine Sulphate suppliers with JDMF on PharmaCompass.

    Hydroxychloroquine Sulphate KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Hydroxychloroquine Sulphate Drug Master File in Korea (Hydroxychloroquine Sulphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydroxychloroquine Sulphate. The MFDS reviews the Hydroxychloroquine Sulphate KDMF as part of the drug registration process and uses the information provided in the Hydroxychloroquine Sulphate KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Hydroxychloroquine Sulphate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Hydroxychloroquine Sulphate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Hydroxychloroquine Sulphate suppliers with KDMF on PharmaCompass.

    Hydroxychloroquine Sulphate CEP

    A Hydroxychloroquine Sulphate CEP of the European Pharmacopoeia monograph is often referred to as a Hydroxychloroquine Sulphate Certificate of Suitability (COS). The purpose of a Hydroxychloroquine Sulphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydroxychloroquine Sulphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydroxychloroquine Sulphate to their clients by showing that a Hydroxychloroquine Sulphate CEP has been issued for it. The manufacturer submits a Hydroxychloroquine Sulphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydroxychloroquine Sulphate CEP holder for the record. Additionally, the data presented in the Hydroxychloroquine Sulphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydroxychloroquine Sulphate DMF.

    A Hydroxychloroquine Sulphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydroxychloroquine Sulphate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Hydroxychloroquine Sulphate suppliers with CEP (COS) on PharmaCompass.

    Hydroxychloroquine Sulphate WC

    A Hydroxychloroquine Sulphate written confirmation (Hydroxychloroquine Sulphate WC) is an official document issued by a regulatory agency to a Hydroxychloroquine Sulphate manufacturer, verifying that the manufacturing facility of a Hydroxychloroquine Sulphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hydroxychloroquine Sulphate APIs or Hydroxychloroquine Sulphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Hydroxychloroquine Sulphate WC (written confirmation) as part of the regulatory process.

    click here to find a list of Hydroxychloroquine Sulphate suppliers with Written Confirmation (WC) on PharmaCompass.

    Hydroxychloroquine Sulphate NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Hydroxychloroquine Sulphate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Hydroxychloroquine Sulphate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Hydroxychloroquine Sulphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydroxychloroquine Sulphate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Hydroxychloroquine Sulphate suppliers with NDC on PharmaCompass.

    Hydroxychloroquine Sulphate GMP

    Hydroxychloroquine Sulphate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Hydroxychloroquine Sulphate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Hydroxychloroquine Sulphate GMP manufacturer or Hydroxychloroquine Sulphate GMP API supplier for your needs.

    Hydroxychloroquine Sulphate CoA

    A Hydroxychloroquine Sulphate CoA (Certificate of Analysis) is a formal document that attests to Hydroxychloroquine Sulphate's compliance with Hydroxychloroquine Sulphate specifications and serves as a tool for batch-level quality control.

    Hydroxychloroquine Sulphate CoA mostly includes findings from lab analyses of a specific batch. For each Hydroxychloroquine Sulphate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Hydroxychloroquine Sulphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydroxychloroquine Sulphate EP), Hydroxychloroquine Sulphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydroxychloroquine Sulphate USP).

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