Synopsis
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CEP/COS
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JDMF
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VMF
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EDQM
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USP
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JP
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Others
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Australia
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Regulatory FDF Prices
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1. Carbonate, Sevelamer
2. Gt335 012
3. Gt335-012
4. Gt335012
5. Hydrochloride, Sevelamer
6. Renagel
7. Sevelamer
8. Sevelamer Hydrochloride
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
Molecular Weight | 211.64 g/mol |
---|---|
Molecular Formula | C7H14ClNO4 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 2 |
Exact Mass | 211.0611356 g/mol |
Monoisotopic Mass | 211.0611356 g/mol |
Topological Polar Surface Area | 96.1 Ų |
Heavy Atom Count | 13 |
Formal Charge | 0 |
Complexity | 81.4 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
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.
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.)
V03AE02
V03AE02
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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.
A carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine, including repackagers and relabelers. The FDA regulates carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine 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 carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine supplier is an individual or a company that provides carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine active pharmaceutical ingredient (API) or carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine finished formulations upon request. The carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine suppliers may include carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine API manufacturers, exporters, distributors and traders.
click here to find a list of carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine DMF (Drug Master File) is a document detailing the whole manufacturing process of carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine active pharmaceutical ingredient (API) in detail. Different forms of carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine DMFs exist exist since differing nations have different regulations, such as carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine DMF submitted to regulatory agencies in the US is known as a USDMF. carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine USDMF includes data on carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine Drug Master File in Korea (carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine. The MFDS reviews the carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine KDMF as part of the drug registration process and uses the information provided in the carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine KDMF to evaluate the safety and efficacy of the drug.
After submitting a carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine 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 carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine suppliers with KDMF on PharmaCompass.
A carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine written confirmation (carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine WC) is an official document issued by a regulatory agency to a carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine manufacturer, verifying that the manufacturing facility of a carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine APIs or carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine finished pharmaceutical products to another nation, regulatory agencies frequently require a carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine WC (written confirmation) as part of the regulatory process.
click here to find a list of carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine suppliers with Written Confirmation (WC) on PharmaCompass.
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 carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine API and other APIs are published in this directory by the FDA.
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 carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine 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.
The NDC directory also contains data on finished compounded human drug products that contain carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine suppliers with NDC on PharmaCompass.
carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine 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 carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine 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 carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine GMP manufacturer or carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine GMP API supplier for your needs.
A carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine CoA (Certificate of Analysis) is a formal document that attests to carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine's compliance with carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine specifications and serves as a tool for batch-level quality control.
carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine CoA mostly includes findings from lab analyses of a specific batch. For each carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine 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.
carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine may be tested according to a variety of international standards, such as European Pharmacopoeia (carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine EP), carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (carbonic acid;2-(chloromethyl)oxirane;prop-2-en-1-amine USP).