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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

12 API Suppliers, 2 USDMF, 4 CEP/COS, 1 JDMF, 2 EU WC, 2 NDC API, 6 Listed Suppliers, $ API Reference Price

12 API Suppliers
2 USDMF
4 CEP/COS
1 JDMF
2 EU WC
2 NDC API
6 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

22 FDF Dossiers, 8 Europe, 1 South Africa, 13 Listed Dossiers

22 FDF Dossiers
8 Europe
1 South Africa
13 Listed Dossiers

DIGITAL CONTENT

1 NEWS #PharmaBuzz

media
1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 Finished Drug Prices

globalSalesInformation
4 Finished Drug Prices

MARKET PLACE

6 APIs, 2 FDF Dossiers

marketPlace
6 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 1 Others

otherSolutions
2 EDQM
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

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

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Chemistry

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Also known as: Quinine hcl, 130-89-2, Quinine muriate, Chinimetten, Quinine monohydrochloride, Fema no. 2976

Molecular Formula

C₂₀H₂₅ClN₂O₂

Molecular Weight

360.9 g/mol

InChI Key

LBSFSRMTJJPTCW-DSXUQNDKSA-N

FDA UNII

7CS0WNO31M

An alkaloid derived from the bark of the cinchona tree. It is used as an antimalarial drug, and is the active ingredient in extracts of the cinchona that have been used for that purpose since before 1633. Quinine is also a mild antipyretic and analgesic and has been used in common cold preparations for that purpose. It was used commonly and as a bitter and flavoring agent, and is still useful for the treatment of babesiosis. Quinine is also useful in some muscular disorders, especially nocturnal leg cramps and myotonia congenita, because of its direct effects on muscle membrane and sodium channels. The mechanisms of its antimalarial effects are not well understood.

1 2D Structure

Quinine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(R)-[(2S,4S,5R)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-(6-methoxyquinolin-4-yl)methanol;hydrochloride

2.1.2 InChI

InChI=1S/C20H24N2O2.ClH/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;1H/t13-,14-,19-,20+;/m0./s1

2.1.3 InChI Key

LBSFSRMTJJPTCW-DSXUQNDKSA-N

2.1.4 Canonical SMILES

COC1=CC2=C(C=CN=C2C=C1)C(C3CC4CCN3CC4C=C)O.Cl

2.1.5 Isomeric SMILES

COC1=CC2=C(C=CN=C2C=C1)[C@H]([C@@H]3C[C@@H]4CCN3C[C@@H]4C=C)O.Cl

2.2 Other Identifiers

2.2.1 UNII

7CS0WNO31M

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Biquinate

2. Bisulfate, Quinine

3. Hydrochloride, Quinine

4. Legatrim

5. Myoquin

6. Quinamm

7. Quinbisan

8. Quinbisul

9. Quindan

10. Quinimax

11. Quinine

12. Quinine Bisulfate

13. Quinine Lafran

14. Quinine Sulfate

15. Quinine Sulphate

16. Quinine-odan

17. Quinoctal

18. Quinson

19. Quinsul

20. Strema

21. Sulfate, Quinine

22. Sulphate, Quinine

23. Surquina

2.3.2 Depositor-Supplied Synonyms

1. Quinine Hcl

2. 130-89-2

3. Quinine Muriate

4. Chinimetten

5. Quinine Monohydrochloride

6. Fema No. 2976

7. Ccris 2002

8. Einecs 205-001-1

9. 7549-43-1

10. 7cs0wno31m

11. Anhydrous Quinine Hydrochloride

12. Quinine Hydrochloride Anhydrous

13. Ai3-62121

14. Quinine, Hydrochloride (2:1)

15. Quinine Hydrochloride Dihydrate

16. (r)-[(2s,4s,5r)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl]-(6-methoxyquinolin-4-yl)methanol;hydrochloride

17. Chininum Muriaticum

18. Quinine Chloride

19. Quinine Hydrochloride Hydrate

20. 6119-47-7

21. Cinchonan-9-ol, 6'-methoxy-, Hydrochloride (1:1), (8alpha,9r)-

22. (r)-(6-methoxyquinolin-4-yl)((1s,2s,4s,5r)-5-vinylquinuclidin-2-yl)methanol Hydrochloride

23. 30860-23-2

24. Chinine Hydrochloride

25. Quinine, Hydrochloride

26. Fema No. 2976, Dihydrate-

27. Einecs 231-437-7

28. Unii-7cs0wno31m

29. Quinine, Monohydrochloride

30. Quininehcl

31. Quinini Hydrochloridum

32. (8alpha,9r)-6'-methoxycinchonan-9-ol Monohydrochloride

33. 6'-methoxycinchonan-9-ol Monohydrochloride, (8alpha,9r)-

34. Cinchonan-9-ol, 6'-methoxy-, Monohydrochloride, (8alpha,9r)-

35. Quinine Hydrochloride (1:1)

36. Schembl184367

37. Chembl588046

38. Dtxsid7044213

39. Tcmdc-123484

40. Tcmdc-125479

41. Cinchonan-9-ol, 6'-methoxy-, Hydrochloride, (8alpha,9r)-

42. Cinchonan-9-ol, 6'-methoxy-, Hydrochloride, (8.alpha.,9r)-

43. Cinchonan-9-ol, 6'-methoxy-, Monohydrochloride, (8-alpha,9r)-

44. Quinine Hydrochloride [fhfi]

45. Mfcd00078498

46. Akos016002029

47. Cinchonan-9-ol, 6'-methoxy-, Monohydrochloride, Dihydrate, (8alpha,9r)-

48. Quinine Hydrochloride [who-dd]

49. 6'-methoxycinchonan-9-ol Hydrochloride

50. As-70722

51. Quinine Monohydrochloride Anhydrous

52. Quinine Hydrochloride Anhydrous [mi]

53. A51181

54. Q27268091

55. (8.alpha.,9r)-6'-methoxycinchonan-9-ol Hydrochloride

56. Cinchonan-9-ol, 6'-methoxy-, Hydrochloride (1:?), (8alpha,9r)-

57. (r)-(6-methoxyquinolin-4-yl)((2s,4s,5r)-5-vinylquinuclidin-2-yl)methanol Hydrochloride

58. (r)-[(2s,4s,5r)-5-ethenyl-1-azabicyclo[2.2.2]octan-2-yl](6-methoxyquinolin-4-yl)methanol Hydrochloride

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₂₅ClN₂O₂
Molecular Weight	360.9 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	4
Exact Mass	360.1604557 g/mol
Monoisotopic Mass	360.1604557 g/mol
Topological Polar Surface Area	45.6 Å²
Heavy Atom Count	25
Formal Charge	0
Complexity	457
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Pharmacology and Biochemistry

4.1 MeSH Pharmacological Classification

Analgesics, Non-Narcotic

A subclass of analgesic agents that typically do not bind to OPIOID RECEPTORS and are not addictive. Many non-narcotic analgesics are offered as NONPRESCRIPTION DRUGS. (See all compounds classified as Analgesics, Non-Narcotic.)

Muscle Relaxants, Central

A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)

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.)

API SUPPLIERS

01

Alchem International Private Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI WW Frankfurt

Booth #11.0C48

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

Contact Supplier

India

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC

NDC KDMF VMF Others AUDIT

02

Jai Radhe Sales

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

Jai Radhe Sales is your partner for all your sourcing needs.

Contact Supplier

India

Virtual Booth

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

PT KIMIA FARMA PERSERO TBK

Indonesia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

04

AANJANEYA LIFECARE LIMITED IN

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

05

Arnold Suhr Qimpex Pte. Ltd. SG 04...

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

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API Reference Price

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THOMAS MOUNT"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1639161000,"product":"QUININE HYDROCHLORIDE 2AQ NATURAL","address":"PLOT NO. 25, 26 AND 46, IIND CROSS ANEKAL TALUK","city":"Bengaluru","supplier":"GIVAUDAN","supplierCountry":"MADAGASCAR","foreign_port":"N\/A","customer":"GIVAUDAN INDIA PRIVATE ","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"136.6","totalValueFC":"137.5","currency":"USD","unitRateINR":"10368.4","date":"11-Dec-2021","totalValueINR":"10368.35","totalValueInUsd":"137.5","indian_port":"BOMBAY AIR","hs_no":"29392090","bill_no":"6642829","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MADAGASCAR","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"","customerAddress":"PLOT NO. 25, 26 AND 46, IIND CROSS ANEKAL TALUK"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674757800,"product":"QUININE HYDROCHLORIDE (GOODS ARE FOR TESTING, ANALYSIS AND DEVELOPMENT PURPOSE ONLY AND NOT FOR COMMERCIAL USE)","address":"OFFICENO 5-6COMMERCE AVENUE PAUD R D,S NO 127 MAHAGANESH COL KOTHRUD","city":"PUNE,MAHARASHTRA","supplier":"INTERNATIONAL BUSINESS NETWORKS ","supplierCountry":"INDONESIA","foreign_port":"NA","customer":"BATAVIA PHARMA PRIVATE ","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"115","totalValueFC":"2894","currency":"USD","unitRateINR":"9464.5","date":"27-Jan-2023","totalValueINR":"236612.5","totalValueInUsd":"2894","indian_port":"BOMBAY AIR","hs_no":"29392020","bill_no":"4362447","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"OFFICENO 5-6COMMERCE AVENUE PAUD R D,S NO 127 MAHAGANESH COL KOTHRUD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676399400,"product":"QUININE HYDROCHLORIDE DIHYDRATE (SAMPLE FOR FSSAI)","address":"PLOT NO 1109 1110 VILLAGE,PIRANGU T MULSHI PUNE","city":"PUNE,MAHARASHTRA","supplier":"PT. SINKONA INDONESIA LESTARI","supplierCountry":"INDONESIA","foreign_port":"NA","customer":"COCA COLA INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"114","totalValueFC":"135.8","currency":"USD","unitRateINR":"11212.8","date":"15-Feb-2023","totalValueINR":"11212.83","totalValueInUsd":"135.8","indian_port":"BOMBAY AIR","hs_no":"29392020","bill_no":"4657648","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO 1109 1110 VILLAGE,PIRANGU T MULSHI PUNE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683484200,"product":"QUININE HYDROCHLORIDE 2AQ NATURAL","address":"D PLOT NO 262ND CROSSJIGANI INDUSTRIAL AREAJIGANIANEKAL TALUKBANGALORE","city":"BENGALURU","supplier":"GIVAUDAN AUSTRALIA PTY ","supplierCountry":"MADAGASCAR","foreign_port":"SYDNEY","customer":"GIVAUDAN INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"128.4","totalValueFC":"386.7","currency":"USD","unitRateINR":"10606.1","date":"08-May-2023","totalValueINR":"31818.36","totalValueInUsd":"386.7","indian_port":"BOMBAY AIR","hs_no":"29392020","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"Madagascar","selfForZScoreResived":"Pharma Grade","supplierPort":"SYDNEY","supplierAddress":"","customerAddress":"D PLOT NO 262ND CROSSJIGANI INDUSTRIAL AREAJIGANIANEKAL TALUKBANGALORE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725388200,"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":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"144.3","totalValueFC":"175.9","currency":"USD","unitRateINR":"14739.5","date":"04-Sep-2024","totalValueINR":"14739.46","totalValueInUsd":"175.9","indian_port":"Madras Air","hs_no":"29392090","bill_no":"5421358","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MADAGASCAR","selfForZScoreResived":"Pharma Grade","supplierPort":"MUNICH","supplierAddress":"A-JAUMANN-INDUSTRIEPARK 9 86720 NOERDLINGEN GERMANY GERMANY GERMANY","customerAddress":"140, OLD MAHABALIPURAM ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730658600,"product":"QUININE HYDROCHLORIDE (AROMATIC CHEMICAL)","address":"1-5 SEVEN WELLS STREET","city":"CHENNAI ,TAMILNADU","supplier":"QIMPEXX NETHERLANDS B.V","supplierCountry":"MADAGASCAR","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"INTERNATIONAL FLAVORS AND FRAGRANCES","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"110","totalValueFC":"2930.7","currency":"USD","unitRateINR":"9892.7","date":"04-Nov-2024","totalValueINR":"247316.83","totalValueInUsd":"2930.7","indian_port":"Madras Air","hs_no":"29392090","bill_no":"6491866","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MADAGASCAR","selfForZScoreResived":"Pharma Grade","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"STEIJNLAAN 26 1217 JS HILVERSUMP.O BOX 2225 1200 CE HILVERSUM SDNF NL","customerAddress":"1-5 SEVEN WELLS STREET"}]

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

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

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APIs

Quinine HCl (25 kg) API needed in Malaysia [ENA20420]

A company that focuses on various pharmaceutical products is looking for suppliers of Quinine HCl (25 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

31 Aug 2024

Quinine Dihydrochloride (5 kg/ annum) API needed in Denmark [ENA20372]

A company that focuses on marketing and distribution of various pharmaceutical products is looking for suppliers of BP Grade Quinine Dihydrochloride (5 kg/ annum) API for commercial purposes. The suppliers must support this enquiry with GMP & CoA.

27 Aug 2024

Food Grade Quinine Hydrochloride (1000 kg) API needed in France [ENA19222]

A company that focuses on distribution of various pharmaceutical, cosmetic, chemical, food & nutraceutical products is looking for suppliers of Food Grade Quinine Hydrochloride (1 MT) API for commercial purposes. The suppliers must support this enquiry with CoA.

20 Mar 2024

Quinine HCl API needed in India [ENA14461]

A company that deals in export & distribution of various pharmaceutical products is looking for suppliers of Quinine HCl API for commercial purpose. The suppliers must support this enquiry with active USDMF, GMP & CoA.

26 Jul 2022

Quinine Sulfate & Quinine Hydrochloride Dihydrate APIs needed in Poland [ENA11224]

A company that deals in research and development, production, & marketing of various pharmaceutical medications in several segments is looking for suppliers of Quinine Sulfate & Quinine Hydrochloride Dihydrate APIs for development purpose. The required quantity is 1 kg - 2 kg for each. The suppliers must support this enquiry with USDMF/ ASMF and GMP.

26 Aug 2021

Quinine Hydrochloride (100 kg) API needed in Nigeria [ENA09887]

A company that deals in pharmaceutical products is looking for suppliers of Quinine Hydrochloride (100 kg) API for commercial purposes. The suppliers must support this enquiry with GMP, DMF (open & closed part) and CoA.

06 Mar 2021

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ABOUT THIS PAGE

Quinine Hydrochloride Manufacturers

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

Quinine Hydrochloride Suppliers

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

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

Quinine Hydrochloride USDMF

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

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

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

Quinine Hydrochloride 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 Quinine Hydrochloride Drug Master File in Japan (Quinine Hydrochloride JDMF) empowers Quinine Hydrochloride 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 Quinine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Quinine Hydrochloride 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 Quinine Hydrochloride suppliers with JDMF on PharmaCompass.

Quinine Hydrochloride CEP

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

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

Quinine Hydrochloride WC

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

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

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

Finished drug products

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

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

Quinine Hydrochloride GMP

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

Quinine Hydrochloride CoA

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

Quinine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Quinine Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Quinine Hydrochloride EP), Quinine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quinine Hydrochloride 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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ACTIVE PHARMA INGREDIENTS

12 API Suppliers

2 USDMF

4 CEP/COS

1 JDMF

2 EU WC

2 NDC API

6 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

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1 South Africa

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2 EDQM

1 USP

1 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

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Average Price (USD/KGS)

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Quinine Hydrochloride Manufacturers

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