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Quinine Sulfate

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 7 USDMF, 4 CEP/COS, 3 EU WC, 6 NDC API, 7 Listed Suppliers, $ API Reference Price

17 API Suppliers
7 USDMF
4 CEP/COS
3 EU WC
6 NDC API
7 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

32 FDF Dossiers, 6 FDA Orange Book, 3 Europe, 5 Canada, 1 Australia, 3 South Africa, 14 Listed Dossiers

32 FDF Dossiers
6 FDA Orange Book
3 Europe
5 Canada
1 Australia
3 South Africa
14 Listed Dossiers

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EXCIPIENTS BY APPLICATIONS

49 Fillers, Diluents & Binders, 26 Direct Compression, 21 Thickeners and Stabilizers, 19 Disintegrants & Superdisintegrants, 18 Lubricants & Glidants, 18 Coating Systems & Additives, 17 Granulation, 13 Co-Processed Excipients, 12 Controlled & Modified Release, 12 Taste Masking, 10 Film Formers & Plasticizers, 8 Parenteral, 8 Empty Capsules, 8 Solubilizers, 6 Topical, 5 Chewable & Orodispersible Aids, 4 Emulsifying Agents, 3 Coloring Agents, 2 Rheology Modifiers, 2 API Stability Enhancers, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

4 NEWS #PharmaBuzz

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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 5 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
5 Finished Drug Prices

MARKET PLACE

8 APIs, 3 FDF Dossiers

marketPlace
8 APIs
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 USP , 1 Others

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1 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 98

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

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

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News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

542,800

Annual Reports (USD Million)

Finished Drug Prices

159 RELATED EXCIPIENT COMPANIES

262EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₂₀H₂₄N₂O₂
Molecular Weight	324.4 g/mol
XLogP3	2.9
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	4
Exact Mass	324.183778013 g/mol
Monoisotopic Mass	324.183778013 g/mol
Topological Polar Surface Area	45.6 Å²
Heavy Atom Count	24
Formal Charge	0
Complexity	457
Isotope Atom Count	0
Defined Atom Stereocenter Count	3
Undefined Atom Stereocenter Count	1
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 2
Drug Name	Quinine sulfate
Drug Label	Quinine 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 Ingredient	Quinine sulfate
Dosage Form	Capsule
Route	Oral
Strength	324mg
Market Status	Prescription
Company	Mylan Pharms; Teva Pharms

2 of 2
Drug Name	Quinine sulfate
Drug Label	Quinine 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 Ingredient	Quinine sulfate
Dosage Form	Capsule
Route	Oral
Strength	324mg
Market Status	Prescription
Company	Mylan 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.

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.

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.

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.

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.

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

API SUPPLIERS

01

Alchem International Private Ltd

India

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Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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Jai Radhe Sales

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Supriya Lifescience

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Vital Laboratories Private Limited

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ARNOLD SUHR NETHERLANDS BV Hilversu...

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Vital Health Care Pvt Ltd Mumbai IN

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EU WC

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Alchem International Private Ltd

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Quinine Sulphate EP/USP

Date of Issue : 2022-05-27

Valid Till : 2025-05-26

Written Confirmation Number : WC-0006

Address of the Firm : 25/2, Main Mathura Road, Village Kalli, Ballabgarh, Faridabad-121 004, Haryana, ...

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Supriya Lifescience

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Quinine Sulphate BP/EP/IP

Date of Issue : 2022-06-29

Valid Till : 2025-07-02

Written Confirmation Number : WC-0218

Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...

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Prism Industries

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Buchler GmbH

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Listed Suppliers

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Alchem International Private Ltd

India

CPhI WW Frankfurt

Booth #11.0C48

Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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Quinine Sulfate

About the Company : Alchem International, established in 1935, is a pioneer in phytochemicals, providing plant-derived active pharmaceutical ingredients to the pharmaceutical, cosmetic and nutraceutic...

Alchem International, established in 1935, is a pioneer in phytochemicals, providing plant-derived active pharmaceutical ingredients to the pharmaceutical, cosmetic and nutraceutical industries. With over 75 years of experience, Alchem has established a global presence, selling its products in more than 35 countries. Alchem has three manufacturing sites spread across 62 acres in India and four international divisions with offices in India, Europe, Hong Kong and the US. Alchem has two divisions – Phytoceuticals and EpiQue – that provide healthcare and cosmetic products to the Indian market and employs over 1,000 people worldwide.

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Jai Radhe Sales

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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.

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API Reference Price

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TCG LIFESCIENCES P.LTD .,BL-BN,PL-7,SEC-V,SALT LAKE ELECTR","city":"NORTH 24 PARGANAS","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"HAMBURG FUHLSBUETT","customer":"CLININVENT RESEARCH PRIVATE LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"352","totalValueFC":"19453.6","currency":"EUR","unitRateINR":"32014.4","date":"29-May-2023","totalValueINR":"1600720","totalValueInUsd":"19453.6","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"Germany","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG FUHLSBUETT","supplierAddress":"","customerAddress":"HOLDING CO. TCG LIFESCIENCES P.LTD .,BL-BN,PL-7,SEC-V,SALT LAKE ELECTR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686249000,"product":"QUININE SULFATE","address":"201, DEVAVRATA, SECTOR 17,,VASHI, NAVI MUMBAI,","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"NA","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"114","totalValueFC":"124615.1","currency":"EUR","unitRateINR":"10242.6","date":"09-Jun-2023","totalValueINR":"10242900.37","totalValueInUsd":"124615.1","indian_port":"BANGALORE AIR","hs_no":"29392090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"201, DEVAVRATA, SECTOR 17,,VASHI, NAVI MUMBAI,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700245800,"product":"QUININE SULFATE (QUININE SULPHATE BP)","address":"A-5, MEGH MALHAR, GAVAND PATH,","city":"THANE ,MAHARASHTRA","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"MILAN LABORATORIES INDIA PVT. LTD.","customerCountry":"INDIA","quantity":"850.00","actualQuantity":"850","unit":"KGS","unitRateFc":"130","totalValueFC":"121751.7","currency":"EUR","unitRateINR":"11927.5","date":"18-Nov-2023","totalValueINR":"10138375","totalValueInUsd":"121751.7","indian_port":"Bombay Air","hs_no":"29392030","bill_no":"8826136","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"HARXBUTTELER STR.3 38110 BRAUNSCHWEIG GERMANYSDNF Germany","customerAddress":"A-5, MEGH MALHAR, GAVAND PATH,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709317800,"product":"14120 QUININE SULFATE 1000308 (30 DRUM)","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"116","totalValueFC":"189955.4","currency":"EUR","unitRateINR":"10515.4","date":"02-Mar-2024","totalValueINR":"15773100","totalValueInUsd":"189955.4","indian_port":"Bangalore Air","hs_no":"29392090","bill_no":"2400439","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"HARXBUETTELER STR. 338110 BRUNSWICK, GERMANY","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711564200,"product":"14120 QUININE SULFATE 1000308 (46 DRUM)","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"2300.00","actualQuantity":"2300","unit":"KGS","unitRateFc":"116","totalValueFC":"297209.2","currency":"EUR","unitRateINR":"10730","date":"28-Mar-2024","totalValueINR":"24679000","totalValueInUsd":"297209.2","indian_port":"Bangalore Air","hs_no":"29392090","bill_no":"2788613","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"HARXBUETTELER STR. 338110 BRUNSWICK, GERMANY","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712601000,"product":"14120 QUININE SULFATE 1000308 (20 DRUM)","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"116","totalValueFC":"127866.7","currency":"EUR","unitRateINR":"10677.8","date":"09-Apr-2024","totalValueINR":"10677800","totalValueInUsd":"127866.7","indian_port":"Bangalore Air","hs_no":"29392090","bill_no":"2943549","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"HARXBUETTELER STR. 338110 BRUNSWICK, GERMANY","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713897000,"product":"QUININE SULFATE, - A\/N: 14070 (CASNO: 6119-70-6 \/ 207671-44-1) (AS PER INVOICE)","address":"802, BLOCK-A, ALPINE HEIGHTS","city":"HYDERABAD, A.P.","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"TIEFENBACHER API + INGREDIENTS GMBH","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"130","totalValueFC":"56510","currency":"EUR","unitRateINR":"11797.5","date":"24-Apr-2024","totalValueINR":"4719000","totalValueInUsd":"56510","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"3179901","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"HARXBUTTELER STRABE 338110 BRAUNSCHWEIGSDNF DE","customerAddress":"802, BLOCK-A, ALPINE HEIGHTS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717698600,"product":"QUININE HYDROCHLORIDE DIHYDRATE NAT","address":"140, OLD MAHABALIPURAM ROAD,","city":"CHENNAI, TAMIL NADU.","supplier":"SYMRISE","supplierCountry":"MADAGASCAR","foreign_port":"MUNICH","customer":"SYMRISE","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"164.7","totalValueFC":"599.2","currency":"USD","unitRateINR":"16674","date":"07-Jun-2024","totalValueINR":"50022.02","totalValueInUsd":"599.2","indian_port":"Madras Air","hs_no":"29392090","bill_no":"3874894","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MADAGASCAR","selfForZScoreResived":"Pharma Grade","supplierPort":"MUNICH","supplierAddress":"A-JAUMANN-INDUSTRIEPARK 986720 NOERDLINGENGERMANY GERMANY","customerAddress":"140, OLD MAHABALIPURAM ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718303400,"product":"14120 QUININE SULFATE 1000308 (3 DRUM)","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"116","totalValueFC":"19269.8","currency":"EUR","unitRateINR":"10724.2","date":"14-Jun-2024","totalValueINR":"1608630","totalValueInUsd":"19269.8","indian_port":"Bangalore Air","hs_no":"29392090","bill_no":"3986445","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"HARXBUETTELER STR. 338110 BRUNSWICK, GERMANY","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721932200,"product":"QUININE SULFATE (QUININE SULPHATE BP)","address":"A-5, MEGH MALHAR, GAVAND PATH,","city":"THANE ,MAHARASHTRA","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"MILAN LABORATORIES INDIA PVT. LTD.","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"125","totalValueFC":"55448.5","currency":"EUR","unitRateINR":"11587.5","date":"26-Jul-2024","totalValueINR":"4635000","totalValueInUsd":"55448.5","indian_port":"Bombay Air","hs_no":"29392030","bill_no":"4712487","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"HARXBUTTELER STR.3 38110 BRAUNSCHWEIG GERMANYSDNF Germany","customerAddress":"A-5, MEGH MALHAR, GAVAND PATH,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723141800,"product":"QUININE SULFATE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"230","totalValueFC":"11756.2","currency":"USD","unitRateINR":"19721.9","date":"09-Aug-2024","totalValueINR":"986092.65","totalValueInUsd":"11756.2","indian_port":"Bombay Air","hs_no":"29392090","bill_no":"4971715","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"HARXBUTTELER STRABE 3 D-38110 BRAUNSCHWEIG Braunschweig, , GermanySDNF Germany","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726770600,"product":"QUININE SULFATE (QUININE SULPHATE BP)","address":"A-5, MEGH MALHAR, GAVAND PATH,","city":"THANE ,MAHARASHTRA","supplier":"BUCHLER GMBH","supplierCountry":"GERMANY","foreign_port":"HANNOVER","customer":"MILAN LABORATORIES INDIA PVT. LTD.","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"125","totalValueFC":"7062.8","currency":"EUR","unitRateINR":"11837.5","date":"20-Sep-2024","totalValueINR":"591875","totalValueInUsd":"7062.8","indian_port":"Bombay Air","hs_no":"29392030","bill_no":"5701077","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HANNOVER","supplierAddress":"HARXBUTTELER STR.3 38110 BRAUNSCHWE IG GERMANY SDNF Germany","customerAddress":"A-5, MEGH MALHAR, GAVAND PATH,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"TFB-BISQUININE","address":"PLOT NO. 74A D.NO. 8-2-293\/82\/A\/74A","city":"HYDERABAD, A.P","supplier":"SYNGENTA CROP PROTECTION ","supplierCountry":"SWITZERLAND","foreign_port":"ROTTERDAM","customer":"DECCAN FINE CHEMICALS ","customerCountry":"INDIA","quantity":"8000.00","actualQuantity":"8000","unit":"KGS","unitRateFc":"26887.5","totalValueFC":"2559909.7","currency":"INR","unitRateINR":"26887.5","date":"21-Oct-2024","totalValueINR":"215100389.3","totalValueInUsd":"2559909.7","indian_port":"Vizag Sea","hs_no":"29334900","bill_no":"6241860","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"ROSENTALSTRASSE 67 CH-4058 BASEL SWITZERLAND CH","customerAddress":"PLOT NO. 74A D.NO. 8-2-293\/82\/A\/74A"}]

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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FDF Dossiers

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FDA Orange Book

01

AMNEAL PHARMS

U.S.A

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02

AUROBINDO PHARMA USA

India

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03

LUPIN LTD

India

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04

NOVAST LABS

China

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05

SUN PHARM INDUSTRIES

India

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06

TEVA PHARMS

Israel

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Europe

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ZETA FARMACEUTICI SPA

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02

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ABOUT THIS PAGE

Quinine Sulfate Manufacturers

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

Quinine Sulfate Suppliers

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

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

Quinine Sulfate USDMF

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

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

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

Quinine Sulfate CEP

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

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

Quinine Sulfate WC

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

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

Quinine Sulfate 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 Quinine Sulfate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Quinine Sulfate GMP

Quinine Sulfate 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 Quinine Sulfate 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 Quinine Sulfate GMP manufacturer or Quinine Sulfate GMP API supplier for your needs.

Quinine Sulfate CoA

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

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

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

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers

7 USDMF

4 CEP/COS

3 EU WC

6 NDC API

7 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

32 FDF Dossiers

6 FDA Orange Book

3 Europe

5 Canada

1 Australia

3 South Africa

14 Listed Dossiers

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EXCIPIENTS BY APPLICATIONS

49 Fillers, Diluents & Binders

26 Direct Compression

21 Thickeners and Stabilizers

19 Disintegrants & Superdisintegrants

18 Lubricants & Glidants

18 Coating Systems & Additives

17 Granulation

13 Co-Processed Excipients

12 Controlled & Modified Release

12 Taste Masking

10 Film Formers & Plasticizers

8 Parenteral

8 Empty Capsules

8 Solubilizers

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