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1. Carbonate, Sevelamer
2. Gt335 012
3. Gt335-012
4. Gt335012
5. Hydrochloride, Sevelamer
6. Renagel
7. Sevelamer
8. Sevelamer Carbonate
1. Sevelamer Hcl
2. 152751-57-0
3. 2-(chloromethyl)oxirane;prop-2-en-1-amine;hydrochloride
4. 182683-00-7
5. Chebi:32127
6. Bcp21176
7. Cga75157
8. Sevelamer Hydrochloride (jan/usan)
9. S4129
10. Akos025149504
11. Ac-2089
12. Hs-0082
13. Db-063954
14. Ft-0653684
15. D01983
16. Ab01568265_01
17. 2-propen-1-amine Hydrochloride Polymer With (chloromethyl)oxirane
| Molecular Weight | 186.08 g/mol |
|---|---|
| Molecular Formula | C6H13Cl2NO |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 2 |
| Exact Mass | 185.0374194 g/mol |
| Monoisotopic Mass | 185.0374194 g/mol |
| Topological Polar Surface Area | 38.6 Ų |
| Heavy Atom Count | 10 |
| Formal Charge | 0 |
| Complexity | 55.1 |
| 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 |
Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 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
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GDUFA
DMF Review : Reviewed
Rev. Date : 2023-12-20
Pay. Date : 2023-09-18
DMF Number : 38198
Submission : 2023-06-27
Status : Active
Type : II
Registration Number : 218MF10733
Registrant's Address : 37 Hollands Road, Haverhill, Suffolk CB9 8PU, U.S. K.
Initial Date of Registration : 2006-09-06
Latest Date of Registration :
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38016
Submission : 2023-03-01
Status : Active
Type : II
Date of Issue : 2022-08-18
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
Together we can improve the quality of life
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-05
Pay. Date : 2013-09-25
DMF Number : 21104
Submission : 2007-11-29
Status : Active
Type : II
Date of Issue : 2022-08-31
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25434
Submission : 2011-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14695
Submission : 2000-02-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25579
Submission : 2011-11-30
Status : Inactive
Type : II
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DOSAGE - TABLET;ORAL - 400MG
USFDA APPLICATION NUMBER - 21179
DOSAGE - TABLET;ORAL - 800MG
USFDA APPLICATION NUMBER - 21179
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PharmaCompass offers a list of Sevelamer 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 Sevelamer Hydrochloride manufacturer or Sevelamer Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sevelamer Hydrochloride manufacturer or Sevelamer Hydrochloride supplier.
PharmaCompass also assists you with knowing the Sevelamer Hydrochloride API Price utilized in the formulation of products. Sevelamer Hydrochloride API Price is not always fixed or binding as the Sevelamer Hydrochloride Price is obtained through a variety of data sources. The Sevelamer Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sevelamer Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sevelamer Hydrochloride, including repackagers and relabelers. The FDA regulates Sevelamer Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sevelamer 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 Sevelamer Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sevelamer Hydrochloride supplier is an individual or a company that provides Sevelamer Hydrochloride active pharmaceutical ingredient (API) or Sevelamer Hydrochloride finished formulations upon request. The Sevelamer Hydrochloride suppliers may include Sevelamer Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sevelamer Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sevelamer Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sevelamer Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sevelamer Hydrochloride DMFs exist exist since differing nations have different regulations, such as Sevelamer Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sevelamer Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sevelamer Hydrochloride USDMF includes data on Sevelamer Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sevelamer Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sevelamer Hydrochloride suppliers with USDMF on PharmaCompass.
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 Sevelamer Hydrochloride Drug Master File in Japan (Sevelamer Hydrochloride JDMF) empowers Sevelamer 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 Sevelamer Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Sevelamer 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 Sevelamer Hydrochloride suppliers with JDMF on PharmaCompass.
A Sevelamer Hydrochloride written confirmation (Sevelamer Hydrochloride WC) is an official document issued by a regulatory agency to a Sevelamer Hydrochloride manufacturer, verifying that the manufacturing facility of a Sevelamer Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sevelamer Hydrochloride APIs or Sevelamer Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Sevelamer Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Sevelamer Hydrochloride 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 Sevelamer Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sevelamer Hydrochloride 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 Sevelamer 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.
The NDC directory also contains data on finished compounded human drug products that contain Sevelamer Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sevelamer Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sevelamer Hydrochloride suppliers with NDC on PharmaCompass.
Sevelamer 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 Sevelamer 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 Sevelamer Hydrochloride GMP manufacturer or Sevelamer Hydrochloride GMP API supplier for your needs.
A Sevelamer Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Sevelamer Hydrochloride's compliance with Sevelamer Hydrochloride specifications and serves as a tool for batch-level quality control.
Sevelamer Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sevelamer 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.
Sevelamer Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sevelamer Hydrochloride EP), Sevelamer Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sevelamer Hydrochloride USP).
