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    Chemistry

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    Also known as: 845273-93-0, 2-propen-1-amine polymer with (chloromethyl)oxirane carbonate, Carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine, Sevelamercarbonate, Gt-335-012, Chembl1201799
    Molecular Formula
    C7H14ClNO4
    Molecular Weight
    211.64  g/mol
    InChI Key
    PADGNZFOVSZIKZ-UHFFFAOYSA-N
    Sevelamer Carbonate
    A polymeric amine that binds phosphate and is used to treat HYPERPHOSPHATEMIA in patients with kidney disease.
    1 2D Structure

    Sevelamer Carbonate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine
    2.1.2 InChI
    InChI=1S/C3H5ClO.C3H7N.CH2O3/c4-1-3-2-5-3;1-2-3-4;2-1(3)4/h3H,1-2H2;2H,1,3-4H2;(H2,2,3,4)
    2.1.3 InChI Key
    PADGNZFOVSZIKZ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C=CCN.C1C(O1)CCl.C(=O)(O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Carbonate, Sevelamer

    2. Gt335 012

    3. Gt335-012

    4. Gt335012

    5. Hydrochloride, Sevelamer

    6. Renagel

    7. Sevelamer

    8. Sevelamer Hydrochloride

    2.2.2 Depositor-Supplied Synonyms

    1. 845273-93-0

    2. 2-propen-1-amine Polymer With (chloromethyl)oxirane Carbonate

    3. Carbonic Acid;2-(chloromethyl)oxirane;prop-2-en-1-amine

    4. Sevelamercarbonate

    5. Gt-335-012

    6. Chembl1201799

    7. Bcp13411

    8. Ex-a4743

    9. Akos037515475

    10. Hs-0081

    11. Gt335-012

    12. Gt335 012;gt335-012;gt335012;carbonate, Sevelamer

    2.3 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 211.64 g/mol
    Molecular Formula C7H14ClNO4
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count2
    Exact Mass211.0611356 g/mol
    Monoisotopic Mass211.0611356 g/mol
    Topological Polar Surface Area96.1 Ų
    Heavy Atom Count13
    Formal Charge0
    Complexity81.4
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Indication

    Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.

    Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus 1. 78 mmol/l.

    Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.

    Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.

    Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1. 78 mmol/L.

    Sevelamer carbonate Winthrop should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Chelating Agents

    Chemicals that bind to and remove ions from solutions. Many chelating agents function through the formation of COORDINATION COMPLEXES with METALS. (See all compounds classified as Chelating Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Phosphate Chelating Activity [MoA]; Phosphate Binder [EPC]
    5.3 ATC Code

    V03AE02

    V03AE02

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    31-Jan-2022
    23-May-2025
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    ABOUT THIS PAGE

    Looking for 845273-93-0 / Sevelamer Carbonate API manufacturers, exporters & distributors?

    Sevelamer Carbonate manufacturers, exporters & distributors 1

    64

    PharmaCompass offers a list of Sevelamer Carbonate 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 Sevelamer Carbonate manufacturer or Sevelamer Carbonate supplier for your needs.

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

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

    API | Excipient name

    Sevelamer Carbonate

    Synonyms

    845273-93-0, 2-propen-1-amine polymer with (chloromethyl)oxirane carbonate, Carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine, Sevelamercarbonate, Gt-335-012, Chembl1201799

    Cas Number

    845273-93-0

    About Sevelamer Carbonate

    A polymeric amine that binds phosphate and is used to treat HYPERPHOSPHATEMIA in patients with kidney disease.

    Sevelamer Carbonate Manufacturers

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

    Sevelamer Carbonate Suppliers

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

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

    Sevelamer Carbonate USDMF

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

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

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

    Sevelamer Carbonate KDMF

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

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

    After submitting a Sevelamer Carbonate 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 Sevelamer Carbonate API can apply through the Korea Drug Master File (KDMF).

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

    Sevelamer Carbonate WC

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

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

    Sevelamer Carbonate 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 Sevelamer Carbonate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Sevelamer Carbonate GMP

    Sevelamer Carbonate 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 Sevelamer Carbonate 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 Sevelamer Carbonate GMP manufacturer or Sevelamer Carbonate GMP API supplier for your needs.

    Sevelamer Carbonate CoA

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

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

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