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| Molecular Weight | 373.4 g/mol |
|---|---|
| Molecular Formula | C21H15N3O4 |
| XLogP3 | 3.8 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 2 |
| Exact Mass | 373.10625597 g/mol |
| Monoisotopic Mass | 373.10625597 g/mol |
| Topological Polar Surface Area | 98.7 A^2 |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 912 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 2 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Exjade |
| PubMed Health | Deferasirox (By mouth) |
| Drug Classes | Heavy Metal Chelator |
| Drug Label | Exjade(deferasirox) is an iron chelating agent. Exjade tablets for oral suspension contain 125mg, 250mg, or 500mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its st... |
| Active Ingredient | Deferasirox |
| Dosage Form | Tablet, for suspension |
| Route | Oral |
| Strength | 250mg; 125mg; 500mg |
| Market Status | Prescription |
| Company | Novartis |
| 2 of 2 | |
|---|---|
| Drug Name | Exjade |
| PubMed Health | Deferasirox (By mouth) |
| Drug Classes | Heavy Metal Chelator |
| Drug Label | Exjade(deferasirox) is an iron chelating agent. Exjade tablets for oral suspension contain 125mg, 250mg, or 500mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its st... |
| Active Ingredient | Deferasirox |
| Dosage Form | Tablet, for suspension |
| Route | Oral |
| Strength | 250mg; 125mg; 500mg |
| Market Status | Prescription |
| Company | Novartis |
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DOSAGE - GRANULE;ORAL - 180MG
USFDA APPLICATION NUMBER - 207968
DOSAGE - GRANULE;ORAL - 360MG
USFDA APPLICATION NUMBER - 207968
DOSAGE - GRANULE;ORAL - 90MG
USFDA APPLICATION NUMBER - 207968
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PharmaCompass offers a list of Deferasirox 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 Deferasirox manufacturer or Deferasirox supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Deferasirox manufacturer or Deferasirox supplier.
PharmaCompass also assists you with knowing the Deferasirox API Price utilized in the formulation of products. Deferasirox API Price is not always fixed or binding as the Deferasirox Price is obtained through a variety of data sources. The Deferasirox Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Deferasiroxum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deferasiroxum, including repackagers and relabelers. The FDA regulates Deferasiroxum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deferasiroxum 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 Deferasiroxum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Deferasiroxum supplier is an individual or a company that provides Deferasiroxum active pharmaceutical ingredient (API) or Deferasiroxum finished formulations upon request. The Deferasiroxum suppliers may include Deferasiroxum API manufacturers, exporters, distributors and traders.
click here to find a list of Deferasiroxum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Deferasiroxum DMF (Drug Master File) is a document detailing the whole manufacturing process of Deferasiroxum active pharmaceutical ingredient (API) in detail. Different forms of Deferasiroxum DMFs exist exist since differing nations have different regulations, such as Deferasiroxum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Deferasiroxum DMF submitted to regulatory agencies in the US is known as a USDMF. Deferasiroxum USDMF includes data on Deferasiroxum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deferasiroxum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Deferasiroxum 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 Deferasiroxum Drug Master File in Japan (Deferasiroxum JDMF) empowers Deferasiroxum 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 Deferasiroxum JDMF during the approval evaluation for pharmaceutical products. At the time of Deferasiroxum 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 Deferasiroxum suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Deferasiroxum Drug Master File in Korea (Deferasiroxum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Deferasiroxum. The MFDS reviews the Deferasiroxum KDMF as part of the drug registration process and uses the information provided in the Deferasiroxum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Deferasiroxum 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 Deferasiroxum API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Deferasiroxum suppliers with KDMF on PharmaCompass.
A Deferasiroxum CEP of the European Pharmacopoeia monograph is often referred to as a Deferasiroxum Certificate of Suitability (COS). The purpose of a Deferasiroxum CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Deferasiroxum EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Deferasiroxum to their clients by showing that a Deferasiroxum CEP has been issued for it. The manufacturer submits a Deferasiroxum CEP (COS) as part of the market authorization procedure, and it takes on the role of a Deferasiroxum CEP holder for the record. Additionally, the data presented in the Deferasiroxum CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Deferasiroxum DMF.
A Deferasiroxum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Deferasiroxum CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Deferasiroxum suppliers with CEP (COS) on PharmaCompass.
A Deferasiroxum written confirmation (Deferasiroxum WC) is an official document issued by a regulatory agency to a Deferasiroxum manufacturer, verifying that the manufacturing facility of a Deferasiroxum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Deferasiroxum APIs or Deferasiroxum finished pharmaceutical products to another nation, regulatory agencies frequently require a Deferasiroxum WC (written confirmation) as part of the regulatory process.
click here to find a list of Deferasiroxum 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 Deferasiroxum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Deferasiroxum 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 Deferasiroxum 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 Deferasiroxum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Deferasiroxum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Deferasiroxum suppliers with NDC on PharmaCompass.
Deferasiroxum 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 Deferasiroxum 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 Deferasiroxum GMP manufacturer or Deferasiroxum GMP API supplier for your needs.
A Deferasiroxum CoA (Certificate of Analysis) is a formal document that attests to Deferasiroxum's compliance with Deferasiroxum specifications and serves as a tool for batch-level quality control.
Deferasiroxum CoA mostly includes findings from lab analyses of a specific batch. For each Deferasiroxum 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.
Deferasiroxum may be tested according to a variety of international standards, such as European Pharmacopoeia (Deferasiroxum EP), Deferasiroxum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Deferasiroxum USP).
