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    Chemistry

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    Also known as: Ncgc00166281-01, Dsstox_cid_24280, Dsstox_rid_80140, Dsstox_gsid_44280, 130-95-0, Cas-130-95-0
    Molecular Formula
    C20H24N2O2
    Molecular Weight
    324.4  g/mol
    InChI Key
    LOUPRKONTZGTKE-VOMFEXJBSA-N
    Quinine Sulfate
    1 2D Structure

    Quinine Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (R)-[(2S,5R)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-(6-methoxyquinolin-4-yl)methanol
    2.1.2 InChI
    InChI=1S/C20H24N2O2/c1-3-13-12-22-9-7-14(13)10-19(22)20(23)16-6-8-21-18-5-4-15(24-2)11-17(16)18/h3-6,8,11,13-14,19-20,23H,1,7,9-10,12H2,2H3/t13-,14?,19-,20+/m0/s1
    2.1.3 InChI Key
    LOUPRKONTZGTKE-VOMFEXJBSA-N
    2.1.4 Canonical SMILES
    COC1=CC2=C(C=CN=C2C=C1)C(C3CC4CCN3CC4C=C)O
    2.1.5 Isomeric SMILES
    COC1=CC2=C(C=CN=C2C=C1)[C@H]([C@@H]3CC4CCN3C[C@@H]4C=C)O
    2.2 Synonyms
    2.2.1 Depositor-Supplied Synonyms

    1. Ncgc00166281-01

    2. Dsstox_cid_24280

    3. Dsstox_rid_80140

    4. Dsstox_gsid_44280

    5. 130-95-0

    6. Cas-130-95-0

    7. Sr-01000075160

    8. Quinine (ban)

    9. Kinder Quinina (tn)

    10. Lopac0_001029

    11. Mls001304041

    12. Chembl387326

    13. Schembl12310700

    14. Hms2233l08

    15. Tox21_112389

    16. Bdbm50411276

    17. Akos015955637

    18. Tox21_112389_1

    19. Ncgc00274071-01

    20. Smr000718748

    21. C06526

    22. D08460

    23. Sr-01000075160-1

    24. Sr-01000075160-12

    25. (alphar,2s)-alpha-(6-methoxy-4-quinolyl)-5beta-vinyl-2alpha-quinuclidinemethanol

    2.3 Create Date
    2005-07-19
    3 Chemical and Physical Properties
    Molecular Weight 324.4 g/mol
    Molecular Formula C20H24N2O2
    XLogP32.9
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count4
    Exact Mass324.183778013 g/mol
    Monoisotopic Mass324.183778013 g/mol
    Topological Polar Surface Area45.6 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity457
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameQuinine sulfate
    Drug LabelQuinine sulfate is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96.The structural formula o...
    Active IngredientQuinine sulfate
    Dosage FormCapsule
    RouteOral
    Strength324mg
    Market StatusPrescription
    CompanyMylan Pharms; Teva Pharms

    2 of 2  
    Drug NameQuinine sulfate
    Drug LabelQuinine sulfate is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96.The structural formula o...
    Active IngredientQuinine sulfate
    Dosage FormCapsule
    RouteOral
    Strength324mg
    Market StatusPrescription
    CompanyMylan Pharms; Teva Pharms

    4.2 Therapeutic Uses

    Analgesics, Non-Narcotic; Antimalarials; Muscle Relaxants, Central

    National Library of Medicine's Medical Subject Headings. Quinine. Online file (MeSH, 2014). Available from, as of August 28, 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Qualaquin (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Qualaquin (Quinine Sulfate) Capsule (Revised: April 2013). Available from, as of November 20, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1f66fba7-4026-4504-918d-4c88f2835cc0

    Oral quinine sulfate is used in conjunction with IV or oral clindamycin for the treatment of babesiosis caused by Babesia microti. /NOT included in US product label/

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    Although quinine sulfate is not approved by the FDA for the treatment of severe or complicated malaria, the CDC states that oral quinine sulfate can be used in conjunction with doxycycline, tetracycline, or clindamycin for follow-up treatment after an appropriate initial parenteral regimen.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    For more Therapeutic Uses (Complete) data for QUININE (8 total), please visit the HSDB record page.

    4.3 Drug Warning

    /BOXED WARNING/ WARNING: Qualaquin use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. The risk associated with Qualaquin use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit.

    NIH; DailyMed. Current Medication Information for Qualaquin (Quinine Sulfate) Capsule (Revised: April 2013). Available from, as of November 20, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1f66fba7-4026-4504-918d-4c88f2835cc0

    Serious hypersensitivity reactions, including anaphylactic shock, anaphylactoid reactions, urticaria, serious skin rashes (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), angioedema, facial edema, bronchospasm, and pruritus, have been reported with quinine. In addition, thrombocytopenia, hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP), immune thrombocytopenic purpura, blackwater fever, disseminated intravascular coagulation, leukopenia, neutropenia, granulomatous hepatitis, and acute interstitial nephritis have been reported and may also be due to hypersensitivity reactions to the drug.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    Potentially fatal cardiac arrhythmias, including torsades de pointes and ventricular fibrillation, have been reported rarely during quinine therapy. At least 1 case of fatal ventricular arrhythmia has been reported in a geriatric patient with preexisting prolonged QT interval treated with IV quinine sulfate for Plasmodium falciparum malaria.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    Serious, life-threatening, and sometimes fatal hematologic reactions, including thrombocytopenia and thrombocytopenia, hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP), have been reported in patients receiving quinine, especially patients using the drug for unlabeled indications (prevention or treatment of leg cramps or restless leg syndrome). Subsequent development of chronic renal impairment has occurred in patients with quinine-associated TTP.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    For more Drug Warnings (Complete) data for QUININE (37 total), please visit the HSDB record page.

    4.4 Minimum/Potential Fatal Human Dose

    The average fatal dose for an adult is about 8 g although deaths have been reported from as little as 1.5 g in an adult and 900 mg in a child.

    IPCS; UK Poison Information Documents (UKPID) for Quinine (Last updated March 1996). Available from, as of November 20, 2014: https://www.inchem.org/pages/ukpids.html

    A lethal dose of quinine has not been clearly defined, but fatalities have been reported after the ingestion of 2 to 8 grams in adults.

    NIH; DailyMed. Current Medication Information for Qualaquin (Quinine Sulfate) Capsule (Revised: April 2013). Available from, as of November 20, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1f66fba7-4026-4504-918d-4c88f2835cc0

    5 Pharmacology and Biochemistry
    5.1 Absorption, Distribution and Excretion

    Following oral administration of a single 600-mg dose of quinine sulfate in healthy adults, the mean plasma clearance was 0.08-0.47 L/hour per kg (median: 0.17 L/hour per kg) and the mean plasma elimination half-life was 9.7-12.5 hours. Following oral administration of 10 mg/kg of quinine sulfate in patients with uncomplicated malaria, mean total clearance of quinine was decreased (approximately 0.09 L/hour per kg) during the acute phase of the infection and increased (approximately 0.16 L/hour per kg) during the recovery or convalescent phase.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    Following oral administration of a single 600-mg dose of quinine sulfate in geriatric and younger adults, the mean clearance of the drug was decreased (0.06 versus 0.08 L/hour per kg) and the mean elimination half-life was significantly increased (18.4 versus 10.5 hours) in geriatric adults compared with younger adults. Although renal clearance of quinine was similar in geriatric and younger adults, geriatric adults excreted a larger proportion of the dose in urine as unchanged drug compared with younger adults (16.6 versus 11.2%). The steady-state pharmacokinetics after a quinine sulfate dosage of 648 mg 3 times daily for 7 days were similar in healthy geriatric adults 65-78 years of age and healthy younger adults 20-39 years of age; however, the mean elimination half-life was 24 hours in the geriatric individuals compared with 20 hours in the younger adults.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    Following oral administration of a single dose of 10 mg/kg of quinine sulfate in healthy children or pediatric patients 1.5-12 years of age with uncomplicated Plasmodium falciparum malaria, the mean total clearance (0.06 versus 0.3 L/hour per kg) is reduced and the plasma elimination half-life increased (12.1 versus 3.21 hours) in pediatric patients with malaria as compared to that observed in healthy children.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    In 15 patients with uncomplicated malaria who received a 10 mg/kg oral dose of quinine sulfate, the mean total clearance of quinine was slower (approximately 0.09 L/hr/kg) during the acute phase of the infection, and faster (approximately 0.16 L/hr/kg) during the recovery or convalescent phase.

    NIH; DailyMed. Current Medication Information for Qualaquin (Quinine Sulfate) Capsule (Revised: April 2013). Available from, as of November 20, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1f66fba7-4026-4504-918d-4c88f2835cc0

    For more Absorption, Distribution and Excretion (Complete) data for QUININE (19 total), please visit the HSDB record page.

    5.2 Metabolism/Metabolites

    In vitro studies using human liver microsomes and recombinant P450 enzymes have shown that quinine is metabolized mainly by CYP3A4. Depending on the in vitro experimental conditions, other enzymes, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1 were shown to have some role in the metabolism of quinine.

    NIH; DailyMed. Current Medication Information for Qualaquin (Quinine Sulfate) Capsule (Revised: April 2013). Available from, as of November 20, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1f66fba7-4026-4504-918d-4c88f2835cc0

    Quinine is metabolized almost exclusively via hepatic oxidative cytochrome P450 (CYP) pathways, resulting in four primary metabolites, 3-hydroxyquinine, 2'-quinone, O-desmethylquinine, and 10,11-dihydroxydihydroquinine. Six secondary metabolites result from further biotransformation of the primary metabolites. The major metabolite, 3-hydroxyquinine, is less active than the parent drug.

    NIH; DailyMed. Current Medication Information for Qualaquin (Quinine Sulfate) Capsule (Revised: April 2013). Available from, as of November 20, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1f66fba7-4026-4504-918d-4c88f2835cc0

    5.3 Biological Half-Life

    Compared with administration of quinine alone, administration of a single 600-mg dose of quinine sulfate in healthy individuals who were receiving ritonavir (200 mg every 12 hours) resulted in an increased quinine mean elimination half-life (11.2 hours versus 13.4 hours).

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    The plasma elimination half-life of quinine reportedly averages 8-21 hours in adults with malaria and 7-12 hours in healthy or convalescing adults.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    The steady-state pharmacokinetics after a quinine sulfate dosage of 648 mg 3 times daily for 7 days were similar in healthy geriatric adults 65-78 years of age and healthy younger adults 20-39 years of age; however, the mean elimination half-life was 24 hours in the geriatric individuals compared with 20 hours in the younger adults.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    In children 1-12 years of age, the plasma elimination half-life of quinine reportedly averages 11-12 hours in those with malaria and 6 hours in those convalescing from the disease.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    At toxic levels elimination half life is reported to be 26.5 + or - 5.8 hrs.

    IPCS; UK Poison Information Documents (UKPID) for Quinine (Last updated March 1996). Available from, as of November 20, 2014: https://www.inchem.org/pages/ukpids.html

    5.4 Mechanism of Action

    Quinine has a local anesthetic action and analgesic, antipyretic, and oxytocic effects. Quinine also has cardiovascular effects similar to those of quinidine.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

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    20-Jan-2022
    20-Jun-2025
    KGS
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    01

    ZETA FARMACEUTICI SPA

    U.S.A
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    ZETA FARMACEUTICI SPA

    U.S.A
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    • fda
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    Brand Name : Quinine Sulphate

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    Quinine

    Brand Name : Quinine Sulphate

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    Dosage Strength : 20 Cpr Riv 250 Mg  

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    Registration Country : Italy

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    Brand Name : Quinine Sulphate

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    Dosage Strength : 20 Cpr 250 Mg  

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    Approval Date :

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    Registration Country : Italy

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    Romania.png
    Various Finished Dosage Formulations needed in Romania [ENA13692]
    A Romanian company that specializes in distribution of various pharmaceutical products is looking for suppliers of Various Finished Dosage Formulations for commercial purpose. The suppliers must support this enquiry with EUGMP & CoA. 1. Miltefosine (50 mg) Capsules. The required quantity is 336 units. 2. Praziquantel (600 mg) Tablets. The required quantity is 300 units. 3. Primaquine (7.5 mg) Tablets. The required quantity is 350 units. 4. Quinine Sulfate (300 mg) Tablets. The required quantity is 300 units.
    20 May 2022

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    20 May 2022

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    Enquiry// Labetalol, Nicardipine and other formulations needed for Regulated/Non-Regulated markets [ENA00536]
    A European pharmaceutical laboratory dedicated to the development, manufacture and marketing of essential medicines to the hospital is searching for following formulations: FOR ASIAN TERRITORIES: 1. Labetalol 25 mg/5ml 2. Noradrenaline 1 mg/1ml base 3. Nicardipine 2 mg/2ml FOR FRANCE: 1. Neostigmine 5 mg/5ml FOR WESTERN EUROPE TERRITORIES: 1. Amiodarone 300 mg/50ml 2. Ketamine 50 mg/50ml 3. Dexamethasone 4 mg/1ml et 20 mg/5ml 4. Atracurium 25 mg/2,5ml/50 mg/5mI et 250 mg/25ml 5. Midazolam 50 mg/50ml 6. Sugammadex 100 mg/2ml et 5 ml FOR FRANCE/ROW TERRITORIES: 1. Isoprenaline 0.2 mg/1ml FOR ROW TERRITORIES: 1. Methylprednisolone 40 mg/5 ml et 20 mg/5ml 2. Quinine 400 mg/4ml 3. Phloroglucinol 40 mg/4 ml FOR WW TERRITORIES: 1. Heparin Sodium 4000 UI ou 5000 UI/1ml 2. Cholecalciferol Vit D 100 000 UI amp buvable 3. Vitamin K1 2 mg/0.2ml nrisson et 10 mg/1ml amp buvable 4. Mepivacaine 1% et 2%/20ml 5. Amiodarone 150 mg/3ml 6. Ketamine 500 mg/10ml
    31 Oct 2017

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    31 Oct 2017

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    Enquiry// Reference Standards for Artesunate, Artemether, Quinine sulfate and various other formulations needed in Laos PDR [ENA00399]
    DDP Chaleunxup Co., Ltd, a trading company providing quality healthcare systems is searching for suppliers of reference standards for following products: 1. Artesunate 50 mg (10/tube) 8 Tubes 2. Lumefantirne/Artemether 120/20 mg (20/tube) 8 Tubes 3. Artemether 50 mg (20/tube) 8 Tubes 4. Quinine sulfate 300 mg (20/tube) 8 Tubes 5. Chloroquine diphosphate 250mg (20/tube) 8 Tubes 6. Doxycycline 20/tube 8 Tubes 7. Doxycycline Hyclate 200 mg USP 3 Vials 8. Chloroquine Phosphate 500 mg USP 2 Vials 9. Amodiaquine Hydrochloride USP 500 mg 2 Vials 10. Doxycycline Hyclate Related compound A USP 200 mg 2 Vials 11. Artesunate 200 mg USP 1 Vial 12. Lumefantirne 100 mg USP 1 Vial 13. Artemether 100 mg USP 1 Vial 14. Quinine sulfate 500 mg USP 1 Vial 15. Artemether related compound A USP 15 mg 1 Vial 16. Artemether related compound B USP RS 15 mg 1 Vial Interested suppliers should contact Mana Phommalangsy via Email: laboratory@ddp.la or Tel: (856)20 55654070.
    08 Jul 2017

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    08 Jul 2017

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    ABOUT THIS PAGE

    Looking for 130-95-0 / Quinine Sulfate API manufacturers, exporters & distributors?

    Quinine Sulfate manufacturers, exporters & distributors 1

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

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Quinine Sulfate manufacturer or Quinine Sulfate supplier.

    PharmaCompass also assists you with knowing the Quinine Sulfate API Price utilized in the formulation of products. Quinine Sulfate API Price is not always fixed or binding as the Quinine Sulfate Price is obtained through a variety of data sources. The Quinine Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Quinine Sulfate

    Synonyms

    Ncgc00166281-01, Dsstox_cid_24280, Dsstox_rid_80140, Dsstox_gsid_44280, 130-95-0, Cas-130-95-0

    Cas Number

    130-95-0

    QUALAQUIN Manufacturers

    A QUALAQUIN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of QUALAQUIN, including repackagers and relabelers. The FDA regulates QUALAQUIN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. QUALAQUIN 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 QUALAQUIN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    QUALAQUIN Suppliers

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

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

    QUALAQUIN USDMF

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

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

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

    QUALAQUIN CEP

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

    A QUALAQUIN CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. QUALAQUIN 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 QUALAQUIN suppliers with CEP (COS) on PharmaCompass.

    QUALAQUIN WC

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

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

    QUALAQUIN 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 QUALAQUIN as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for QUALAQUIN 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 QUALAQUIN 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 QUALAQUIN and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a QUALAQUIN NDC to their finished compounded human drug products, they may choose to do so.

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

    QUALAQUIN GMP

    QUALAQUIN 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 QUALAQUIN 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 QUALAQUIN GMP manufacturer or QUALAQUIN GMP API supplier for your needs.

    QUALAQUIN CoA

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

    QUALAQUIN CoA mostly includes findings from lab analyses of a specific batch. For each QUALAQUIN 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.

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