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    Also known as: 173553-37-2, 107220-28-0, Cevimeline hydrochloride, 2-methyl-1'-azaspiro[[1,3]oxathiolane-5,3'-bicyclo[2.2.2]octane] (hydrochloride), Cevimeline hcl, 2-methylspiro[1,3-oxathiolane-5,3'-1-azabicyclo[2.2.2]octane];hydrochloride
    Molecular Formula
    C10H18ClNOS
    Molecular Weight
    235.77  g/mol
    InChI Key
    SURWTGAXEIEOGY-UHFFFAOYSA-N
    Cevimeline Hydrochloride
    Cevimeline Hydrochloride is a cholinergic analogue with glandular secretion stimulatory activity. Cevimeline binds to and activates muscarinic receptors, thereby increasing the secretions in exocrine salivary and sweat glands. This cholinergic agonist also increases the tone of smooth muscle in the gastrointestinal and urinary tracts. Cevimeline is being studied as a treatment for dry mouth caused by radiation therapy to the head and neck.
    1 2D Structure

    Cevimeline Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-methylspiro[1,3-oxathiolane-5,3'-1-azabicyclo[2.2.2]octane];hydrochloride
    2.1.2 InChI
    InChI=1S/C10H17NOS.ClH/c1-8-12-10(7-13-8)6-11-4-2-9(10)3-5-11;/h8-9H,2-7H2,1H3;1H
    2.1.3 InChI Key
    SURWTGAXEIEOGY-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1OC2(CN3CCC2CC3)CS1.Cl
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. 2-methyspiro(1,3-oxathiolane-5,3)quinuclidine

    2. Af 102b

    3. Af 102b, (cis-(+))-isomer

    4. Af 102b, (trans)-isomer

    5. Af-102b

    6. Af102b

    7. Cevimeline

    8. Cevimeline Hydrochloride

    9. Evoxac

    10. Fks 508

    11. Fks-508

    12. Sni 2011

    13. Sni-2011

    2.2.2 Depositor-Supplied Synonyms

    1. 173553-37-2

    2. 107220-28-0

    3. Cevimeline Hydrochloride

    4. 2-methyl-1'-azaspiro[[1,3]oxathiolane-5,3'-bicyclo[2.2.2]octane] (hydrochloride)

    5. Cevimeline Hcl

    6. 2-methylspiro[1,3-oxathiolane-5,3'-1-azabicyclo[2.2.2]octane];hydrochloride

    7. 2-methyl-1'-azaspiro[[1,3]oxathiolane-5,3'-bicyclo[2.2.2]octane] Hydrochloride

    8. Spiro[1-azabicyclo[2.2.2]octane-3,5'-[1,3]oxathiolane], 2'-methyl-,hydrochloride

    9. Af-102b

    10. Schembl861315

    11. Dtxsid701338114

    12. Bcp12519

    13. Cs-b1634

    14. Yga55337

    15. Akos037650732

    16. Cs-15234

    17. Ft-0664491

    18. A925456

    19. J-001739

    20. (+/-)-cis-2-methylspiro[1,3-oxathiolane-5,3'-quinuclidine]

    21. Cis-2-methylspiro[1,3-oxathiolane-5,3'-quinuclidine]hydrochloride

    22. 2-methyl-1'-azaspiro[[1,3]oxathiolane-5,3'-bicyclo[2.2.2]octane] (hcl)

    23. 5'-methyl-4-azaspiro[bicyclo[2.2.2]octane-2,2'-[1,4]oxathiolane] Hydrochloride

    2.3 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 235.77 g/mol
    Molecular Formula C10H18ClNOS
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count0
    Exact Mass235.0797631 g/mol
    Monoisotopic Mass235.0797631 g/mol
    Topological Polar Surface Area37.8 Ų
    Heavy Atom Count14
    Formal Charge0
    Complexity215
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    Muscarinic Agonists

    Drugs that bind to and activate muscarinic cholinergic receptors (RECEPTORS, MUSCARINIC). Muscarinic agonists are most commonly used when it is desirable to increase smooth muscle tone, especially in the GI tract, urinary bladder and the eye. They may also be used to reduce heart rate. (See all compounds classified as Muscarinic Agonists.)

    Parasympathomimetics

    Drugs that mimic the effects of parasympathetic nervous system activity. Included here are drugs that directly stimulate muscarinic receptors and drugs that potentiate cholinergic activity, usually by slowing the breakdown of acetylcholine (CHOLINESTERASE INHIBITORS). Drugs that stimulate both sympathetic and parasympathetic postganglionic neurons (GANGLIONIC STIMULANTS) are not included here. (See all compounds classified as Parasympathomimetics.)

    4.2 FDA Pharmacological Classification
    4.2.1 Pharmacological Classes
    Cholinergic Receptor Agonist [EPC]; Cholinergic Muscarinic Agonists [MoA]

    API Reference Price

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    05-May-2021
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    ABOUT THIS PAGE

    Cevimeline Hydrochloride Manufacturers

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

    Cevimeline Hydrochloride Suppliers

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

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

    Cevimeline Hydrochloride USDMF

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

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

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

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

    Cevimeline Hydrochloride WC

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

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

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

    Finished drug products

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

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

    Cevimeline Hydrochloride GMP

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

    Cevimeline Hydrochloride CoA

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

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

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