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    Chemistry

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    Also known as: Welchol, Colesevelam hcl, 2-(chloromethyl)oxirane;prop-2-en-1-amine;n-prop-2-enyldecan-1-amine;trimethyl-[6-(prop-2-enylamino)hexyl]azanium;chloride;hydrochloride, Gt 31-104hb, Unii-p4sg24wi5q, Gt-31104
    Molecular Formula
    C31H67Cl3N4O
    Molecular Weight
    618.2  g/mol
    InChI Key
    VTAKZNRDSPNOAU-UHFFFAOYSA-M
    Colesevelam Hydrochloride
    An allylamine derivative that binds BILE ACIDS in the intestine and is used as an ANTICHOLESTEREMIC AGENT in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.
    1 2D Structure

    Colesevelam Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-(chloromethyl)oxirane;prop-2-en-1-amine;N-prop-2-enyldecan-1-amine;trimethyl-[6-(prop-2-enylamino)hexyl]azanium;chloride;hydrochloride
    2.1.2 InChI
    InChI=1S/C13H27N.C12H27N2.C3H5ClO.C3H7N.2ClH/c1-3-5-6-7-8-9-10-11-13-14-12-4-2;1-5-10-13-11-8-6-7-9-12-14(2,3)4;4-1-3-2-5-3;1-2-3-4;;/h4,14H,2-3,5-13H2,1H3;5,13H,1,6-12H2,2-4H3;3H,1-2H2;2H,1,3-4H2;2*1H/q;+1;;;;/p-1
    2.1.3 InChI Key
    VTAKZNRDSPNOAU-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    CCCCCCCCCCNCC=C.C[N+](C)(C)CCCCCCNCC=C.C=CCN.C1C(O1)CCl.Cl.[Cl-]
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. 31104, Gt

    2. Cholestagel

    3. Colesevelam Hcl

    4. Colesevelam Hydrochloride

    5. Gt 31104

    6. Gt-31104

    7. Gt31 104

    8. Gt31-104

    9. Gt31104

    10. Hcl, Colesevelam

    11. Hydrochloride, Colesevelam

    12. Welchol

    2.2.2 Depositor-Supplied Synonyms

    1. Welchol

    2. Colesevelam Hcl

    3. 2-(chloromethyl)oxirane;prop-2-en-1-amine;n-prop-2-enyldecan-1-amine;trimethyl-[6-(prop-2-enylamino)hexyl]azanium;chloride;hydrochloride

    4. Gt 31-104hb

    5. Unii-p4sg24wi5q

    6. Gt-31104

    7. Gt 31-104

    8. Colesevelam Hydrochloride [usan]

    9. P4sg24wi5q

    10. Gt31-104hb

    11. Cholestagel, Colesevelam Hydrochloride

    12. Akos037653488

    13. Hs-0084

    14. Nsc 760126

    15. 1-hexaminium, N,n,n-trimethyl-6-(2-propenylamino)-, Chloride, Polymer With (chloromethyl)oxirane, 2-propen-4-amine And N-2-propenyl-1-decanamine, Hydrochloride

    16. 2-propen-1-amine Polymer With (chloromethyl)oxirane, N,n,n-trimethyl-6-(2-propenylamino)-1-hexanaminium Chloride, And N-2-propenyl-1-decanamine, Hydrochloride

    17. Allylamine Polymer With 1-chloro-2,3-epoxypropane, (6-(allylamino)hexyl)trimethylammonium Chloride And N-allyldecylamine, Hydrochloride

    18. Ft-0697863

    19. Ab01563397_01

    20. Q899036

    2.3 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 618.2 g/mol
    Molecular Formula C31H67Cl3N4O
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count22
    Exact Mass616.438046 g/mol
    Monoisotopic Mass616.438046 g/mol
    Topological Polar Surface Area62.6 Ų
    Heavy Atom Count39
    Formal Charge0
    Complexity301
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count6
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameWelchol
    PubMed HealthColesevelam (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelWELCHOL (colesevelam hydrochloride) is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent intended for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(a...
    Active IngredientColesevelam hydrochloride
    Dosage FormTablet; For suspension
    RouteOral
    Strength625mg; 1.875gm/packet; 3.75gm/packet
    Market StatusPrescription
    CompanyDaiichi Sankyo

    2 of 2  
    Drug NameWelchol
    PubMed HealthColesevelam (By mouth)
    Drug ClassesAntihyperlipidemic
    Drug LabelWELCHOL (colesevelam hydrochloride) is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent intended for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(a...
    Active IngredientColesevelam hydrochloride
    Dosage FormTablet; For suspension
    RouteOral
    Strength625mg; 1.875gm/packet; 3.75gm/packet
    Market StatusPrescription
    CompanyDaiichi Sankyo

    4.2 Drug Indication

    For use, alone or in combination with an HMG-CoA reductase inhibitor, as adjunctive therapy to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa).

    FDA Label

    Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.

    Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.

    Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5. 1).

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Colesevelam is a high capacity bile-acid binding molecule. Colesevelam binds to bile acids in the intestine which reduces the amount of bile acids that are returned to the liver via enterohepatic circulation. Clinical studies have demonstrated that elevated levels of total cholesterol (total-C), LDL-C, and apolipoprotein B (Apo B, a protein associated with LDL-C) are associated with an increased risk of atherosclerosis in humans. Similarly, decreased levels of high-density lipoprotein cholesterol (HDL-C) are associated with the development of atherosclerosis. Epidemiological investigations have established that cardiovascular morbidity and mortality vary directly with the levels of total-C and LDL-C, and inversely with the level of HDL-C. The combination of colesevelam and an HMG-CoA reductase inhibitor is effective in further lowering serum total-C and LDL-C levels beyond that achieved by either agent alone.

    5.2 MeSH Pharmacological Classification

    Anticholesteremic Agents

    Substances used to lower plasma cholesterol levels. (See all compounds classified as Anticholesteremic Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Bile-acid Binding Activity [MoA]; Bile Acid Sequestrant [EPC]
    5.4 ATC Code

    C10AC04

    C - Cardiovascular system

    C10 - Lipid modifying agents

    C10A - Lipid modifying agents, plain

    C10AC - Bile acid sequestrants

    C10AC04 - Colesevelam

    5.5 Absorption, Distribution and Excretion

    Absorption

    Not hydrolyzed by digestive enzymes and is not absorbed.

    Route of Elimination

    Excretion: In 16 healthy volunteers, an average of 0.05% of administered radioactivity from a single 14C-labeled colesevelam hydrochloride dose was excreted in the urine.

    5.6 Metabolism/Metabolites

    Not applicable (not hydrolyzed by digestive enzymes and not absorbed).

    5.7 Mechanism of Action

    Colesevelam binds bile acids in the intestine and prevents their reabsorption. Colesevelam is not absorbed itself. The depletion of bile acid causes the upregulation of cholesterol 7-alpha-hydroxylase and conversion of cholesterol to bile acid. this increases the production and activity of hydroxymethyl-glutaryl-coenzyme A (HMG-CoA) reductase in the liver as well as an increase in the number of low density lipoprotein (LDL) receptors. This process clears LDL cholesterol from the blood. Serum triglyceride levels may increase or remain unchanged. The end result is increased clearance of LDL-cholesterol from the blood with decreased serum LDL-cholesterol.

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MAHARASHTRA","supplier":"XXRMOXX LAXXRATXXIES","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"GLENMARK PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"3810.00","actualQuantity":"3810","unit":"KGS","unitRateFc":"100","totalValueFC":"384666.2","currency":"USD","unitRateINR":"8520","date":"12-Nov-2024","totalValueINR":"32461285","totalValueInUsd":"384666.2","indian_port":"Indore-EPZ\/SEZ","hs_no":"29212990","bill_no":"1007884","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737052200,"product":"COLESEVELAM HYDROCHLORIDE","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"FORMOSA LABORATORIES INC","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"4276.54","actualQuantity":"4276.54","unit":"KGS","unitRateFc":"100","totalValueFC":"431972.7","currency":"USD","unitRateINR":"8710","date":"17-Jan-2025","totalValueINR":"37248663.4","totalValueInUsd":"431972.7","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29420090","bill_no":"7844105","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"No 36 Hoping St Louchu County Taoyuan SDNF Taiwan","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742754600,"product":"COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"FORMOSA LABORATORIES INC","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"ALKEM LABORATORIES LTD","customerCountry":"INDIA","quantity":"3120.16","actualQuantity":"3120.16","unit":"KGS","unitRateFc":"90","totalValueFC":"283026.8","currency":"USD","unitRateINR":"7857","date":"24-Mar-2025","totalValueINR":"24515097.12","totalValueInUsd":"283026.8","indian_port":"JNPT","hs_no":"29212990","bill_no":"9068351","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"NO. 36 HOPING STREET,LOUCHU COUNTY TAOYUAN, TAIWAN 33842 SDNF TAIWAN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742754600,"product":"COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE","address":"ALKEM HOUSE, DEVASHISH ADJACENT T","city":"MUMBAI,MAHARASHTRA","supplier":"FORMOSA LABORATORIES INC","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"ALKEM LABORATORIES LTD","customerCountry":"INDIA","quantity":"2547.17","actualQuantity":"2547.17","unit":"KGS","unitRateFc":"90","totalValueFC":"231051.4","currency":"USD","unitRateINR":"7857","date":"24-Mar-2025","totalValueINR":"20013114.69","totalValueInUsd":"231051.4","indian_port":"JNPT","hs_no":"29212990","bill_no":"9068351","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"NO. 36 HOPING STREET,LOUCHU COUNTY TAOYUAN, TAIWAN 33842 SDNF TAIWAN","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT T"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745778600,"product":"COLESEVELAM HYDROCHLORIDE","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"FORMOSA LABORATORIES INC","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"4031.95","actualQuantity":"4031.95","unit":"KGS","unitRateFc":"100","totalValueFC":"406954.7","currency":"USD","unitRateINR":"8640","date":"28-Apr-2025","totalValueINR":"34836048","totalValueInUsd":"406954.7","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29420090","bill_no":"9758440","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"No.36, Hoping St, Louchu County Taoyuan SDNF Taiwan","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747765800,"product":"COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE","address":"ALKEM HOUSE, DEVASHISH ADJACENT T","city":"MUMBAI,MAHARASHTRA","supplier":"FORMOSA LABORATORIES 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    28-Feb-2022
    20-Aug-2025
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    ABOUT THIS PAGE

    Looking for 182815-43-6 / Colesevelam Hydrochloride API manufacturers, exporters & distributors?

    Colesevelam Hydrochloride manufacturers, exporters & distributors 1

    24

    PharmaCompass offers a list of Colesevelam Hydrochloride 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 Colesevelam Hydrochloride manufacturer or Colesevelam Hydrochloride supplier for your needs.

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

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

    API | Excipient name

    Colesevelam Hydrochloride

    Synonyms

    Welchol, Colesevelam hcl, 2-(chloromethyl)oxirane;prop-2-en-1-amine;n-prop-2-enyldecan-1-amine;trimethyl-[6-(prop-2-enylamino)hexyl]azanium;chloride;hydrochloride, Gt 31-104hb, Unii-p4sg24wi5q, Gt-31104

    Cas Number

    182815-43-6

    About Colesevelam Hydrochloride

    An allylamine derivative that binds BILE ACIDS in the intestine and is used as an ANTICHOLESTEREMIC AGENT in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.

    Colesevelam Hydrochloride Manufacturers

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

    Colesevelam Hydrochloride Suppliers

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

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

    Colesevelam Hydrochloride USDMF

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

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

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

    Colesevelam Hydrochloride WC

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

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

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

    Finished drug products

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

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

    Colesevelam Hydrochloride GMP

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

    Colesevelam Hydrochloride CoA

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

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

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