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    Synopsis

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    Chemistry

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    Also known as: Varenicline tartrate, 375815-87-5, (2s,3s)-2,3-dihydroxybutanedioic acid; 5,8,14-triazatetracyclo[10.3.1.0^{2,11}.0^{4,9}]hexadeca-2(11),3,5,7,9-pentaene, (2s,3s)-2,3-dihydroxybutanedioic acid;5,8,14-triazatetracyclo[10.3.1.02,11.04,9]hexadeca-2,4,6,8,10-pentaene, Akos026750167, As-35136
    Molecular Formula
    C17H19N3O6
    Molecular Weight
    361.3  g/mol
    InChI Key
    TWYFGYXQSYOKLK-WUUYCOTASA-N
    Varenicline Tartrate
    A benzazepine derivative that functions as an ALPHA4-BETA2 NICOTINIC RECEPTOR partial agonist. It is used for SMOKING CESSATION.
    1 2D Structure

    Varenicline Tartrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S,3S)-2,3-dihydroxybutanedioic acid;5,8,14-triazatetracyclo[10.3.1.02,11.04,9]hexadeca-2,4,6,8,10-pentaene
    2.1.2 InChI
    InChI=1S/C13H13N3.C4H6O6/c1-2-16-13-5-11-9-3-8(6-14-7-9)10(11)4-12(13)15-1;5-1(3(7)8)2(6)4(9)10/h1-2,4-5,8-9,14H,3,6-7H2;1-2,5-6H,(H,7,8)(H,9,10)/t;1-,2-/m.0/s1
    2.1.3 InChI Key
    TWYFGYXQSYOKLK-WUUYCOTASA-N
    2.1.4 Canonical SMILES
    C1C2CNCC1C3=CC4=NC=CN=C4C=C23.C(C(C(=O)O)O)(C(=O)O)O
    2.1.5 Isomeric SMILES
    C1C2CNCC1C3=CC4=NC=CN=C4C=C23.[C@H]([C@@H](C(=O)O)O)(C(=O)O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. 6,7,8,9-tetrahydro-6,10-methano-6h-pyrazino(2,3-h)benzazepine

    2. Champix

    3. Varenicline

    4. Varenicline Tartrate

    2.2.2 Depositor-Supplied Synonyms

    1. Varenicline Tartrate

    2. 375815-87-5

    3. (2s,3s)-2,3-dihydroxybutanedioic Acid; 5,8,14-triazatetracyclo[10.3.1.0^{2,11}.0^{4,9}]hexadeca-2(11),3,5,7,9-pentaene

    4. (2s,3s)-2,3-dihydroxybutanedioic Acid;5,8,14-triazatetracyclo[10.3.1.02,11.04,9]hexadeca-2,4,6,8,10-pentaene

    5. Akos026750167

    6. As-35136

    7. A21286

    8. Z1642292115

    2.3 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 361.3 g/mol
    Molecular Formula C17H19N3O6
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count3
    Exact Mass361.12738533 g/mol
    Monoisotopic Mass361.12738533 g/mol
    Topological Polar Surface Area153 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity388
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameChantix
    PubMed HealthVarenicline (By mouth)
    Drug ClassesSmoking Ceation Agent
    Drug LabelCHANTIX tablets contain varenicline (as the tartrate salt), which is a partial agonist selective for 42 nicotinic acetylcholine receptor subtypes.Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow soli...
    Active IngredientVarenicline tartrate
    Dosage FormTablet
    RouteOral
    Strengtheq 0.5mg base; eq 1mg base
    Market StatusPrescription
    CompanyPfizer

    2 of 2  
    Drug NameChantix
    PubMed HealthVarenicline (By mouth)
    Drug ClassesSmoking Ceation Agent
    Drug LabelCHANTIX tablets contain varenicline (as the tartrate salt), which is a partial agonist selective for 42 nicotinic acetylcholine receptor subtypes.Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow soli...
    Active IngredientVarenicline tartrate
    Dosage FormTablet
    RouteOral
    Strengtheq 0.5mg base; eq 1mg base
    Market StatusPrescription
    CompanyPfizer

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Nicotinic Agonists

    Drugs that bind to and activate nicotinic cholinergic receptors (RECEPTORS, NICOTINIC). Nicotinic agonists act at postganglionic nicotinic receptors, at neuroeffector junctions in the peripheral nervous system, and at nicotinic receptors in the central nervous system. Agents that function as neuromuscular depolarizing blocking agents are included here because they activate nicotinic receptors, although they are used clinically to block nicotinic transmission. (See all compounds classified as Nicotinic Agonists.)

    Smoking Cessation Agents

    Substances that facilitate the cessation of tobacco smoking. (See all compounds classified as Smoking Cessation Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Partial Cholinergic Nicotinic Agonists [MoA]; Partial Cholinergic Nicotinic Agonist [EPC]

    API Reference Price

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MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"12.94","actualQuantity":"12.94","unit":"KGS","unitRateFc":"25000","totalValueFC":"326829.9","currency":"USD","unitRateINR":"2102500","date":"01-Dec-2023","totalValueINR":"27206350","totalValueInUsd":"326829.9","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"9021398","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT 6-8 08970 SANT JOAN DESPI BARCELONA , , SPAINSDNF SPAIN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703615400,"product":"VARENICLINE TARTRATE (R00241)","address":"MEDLEY HOUSE,D-2,MIDC AREA","city":"MUMBAI","supplier":"VIWIT PHARMACEUTICALS LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"MEDLEY PHARMACEUTICALS","customerCountry":"INDIA","quantity":"8.38","actualQuantity":"8.38","unit":"KGS","unitRateFc":"26000","totalValueFC":"219337.5","currency":"USD","unitRateINR":"2178800","date":"27-Dec-2023","totalValueINR":"18258344","totalValueInUsd":"219337.5","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9425490","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"88 WEIZHI ROAD, TENGZHOU BIOPHARMAPARK SHANGDONG CHINASDNF China","customerAddress":"MEDLEY HOUSE,D-2,MIDC AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703788200,"product":"VARENICLINE TARTRATE","address":"98, GOVT.INDUSTRIAL AREA,","city":"MUMBAI.","supplier":"VIWIT PHARMACEUTICALS LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"AJANTA PHARMA LIMITED","customerCountry":"INDIA","quantity":"9.91","actualQuantity":"9.91","unit":"KGS","unitRateFc":"30000","totalValueFC":"299288.8","currency":"USD","unitRateINR":"2514000","date":"29-Dec-2023","totalValueINR":"24913740","totalValueInUsd":"299288.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"9464241","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"88 WEIZHI ROAD, TENGZHOU BIOPHARMAPARK SHANGDONG CHINASDNF China","customerAddress":"98, GOVT.INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715193000,"product":"VARENICLINE TARTRATE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"13.00","actualQuantity":"13","unit":"KGS","unitRateFc":"35612.3","totalValueFC":"468491","currency":"USD","unitRateINR":"3003898.2","date":"09-May-2024","totalValueINR":"39050676","totalValueInUsd":"468491","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29333990","bill_no":"1001675","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"08970 SANT JOAN DESPI BARCELONA SPAIN","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718735400,"product":"VARENICLINE TARTRATE (R000241) - QTY 8.174 KGS","address":"MEDLEY HOUSE,D-2,MIDC AREA","city":"MUMBAI","supplier":"VIWIT PHARMACEUTICALS LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"MEDLEY PHARMACEUTICALS","customerCountry":"INDIA","quantity":"8.17","actualQuantity":"8.174","unit":"KGS","unitRateFc":"20000","totalValueFC":"165087","currency":"USD","unitRateINR":"1686000","date":"19-Jun-2024","totalValueINR":"13781364","totalValueInUsd":"165087","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4077792","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"88 WEIZHI ROAD, TENGZHOU BIOPHARMAPARK SHANGDONG CHINASDNF China","customerAddress":"MEDLEY HOUSE,D-2,MIDC AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721327400,"product":"VARENICLINE TARTRATE","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"20.04","actualQuantity":"20.04","unit":"KGS","unitRateFc":"25000","totalValueFC":"506148","currency":"USD","unitRateINR":"2111250","date":"19-Jul-2024","totalValueINR":"42309450","totalValueInUsd":"506148","indian_port":"Delhi Air","hs_no":"29333990","bill_no":"4587369","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"FRUCTUOS GELABERT 6-8 08970 SANT JOAN DESPI BARCELONA , , SPAINSDNF SPAIN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725647400,"product":"VARENICLINE CITRATE API, BATCH NO: TBD-0297-21 (AS PER INVOICE)","address":"802, BLOCK-A, ALPINE HEIGHTS","city":"HYDERABAD, A.P.","supplier":"TBD PHARMATECH LTD","supplierCountry":"ESTONIA","foreign_port":"TALLINN","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"3.59","actualQuantity":"3.589","unit":"KGS","unitRateFc":"7200","totalValueFC":"29216.9","currency":"EUR","unitRateINR":"682200","date":"07-Sep-2024","totalValueINR":"2448415.8","totalValueInUsd":"29216.9","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"5484674","productDescription":"API","marketType":"REGULATED MARKET","country":"ESTONIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TALLINN","supplierAddress":"REG. 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    15-Jan-2021
    18-Dec-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 0.5MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21928

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    DOSAGE - TABLET;ORAL - EQ 1MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21928

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    ABOUT THIS PAGE

    Varenicline Manufacturers

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

    Varenicline Suppliers

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

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

    Varenicline USDMF

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

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

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

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

    Varenicline KDMF

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

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

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

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

    Varenicline WC

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

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

    Varenicline 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 Varenicline as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Varenicline GMP

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

    Varenicline CoA

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

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

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