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PharmaCompass offers a list of Dofetilide 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 Dofetilide manufacturer or Dofetilide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dofetilide manufacturer or Dofetilide supplier.
PharmaCompass also assists you with knowing the Dofetilide API Price utilized in the formulation of products. Dofetilide API Price is not always fixed or binding as the Dofetilide Price is obtained through a variety of data sources. The Dofetilide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dofetilide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dofetilide, including repackagers and relabelers. The FDA regulates Dofetilide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dofetilide 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 Dofetilide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dofetilide supplier is an individual or a company that provides Dofetilide active pharmaceutical ingredient (API) or Dofetilide finished formulations upon request. The Dofetilide suppliers may include Dofetilide API manufacturers, exporters, distributors and traders.
click here to find a list of Dofetilide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dofetilide DMF (Drug Master File) is a document detailing the whole manufacturing process of Dofetilide active pharmaceutical ingredient (API) in detail. Different forms of Dofetilide DMFs exist exist since differing nations have different regulations, such as Dofetilide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dofetilide DMF submitted to regulatory agencies in the US is known as a USDMF. Dofetilide USDMF includes data on Dofetilide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dofetilide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dofetilide suppliers with USDMF on PharmaCompass.
A Dofetilide written confirmation (Dofetilide WC) is an official document issued by a regulatory agency to a Dofetilide manufacturer, verifying that the manufacturing facility of a Dofetilide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dofetilide APIs or Dofetilide finished pharmaceutical products to another nation, regulatory agencies frequently require a Dofetilide WC (written confirmation) as part of the regulatory process.
click here to find a list of Dofetilide 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 Dofetilide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dofetilide 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 Dofetilide 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 Dofetilide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dofetilide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dofetilide suppliers with NDC on PharmaCompass.
Dofetilide 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 Dofetilide 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 Dofetilide GMP manufacturer or Dofetilide GMP API supplier for your needs.
A Dofetilide CoA (Certificate of Analysis) is a formal document that attests to Dofetilide's compliance with Dofetilide specifications and serves as a tool for batch-level quality control.
Dofetilide CoA mostly includes findings from lab analyses of a specific batch. For each Dofetilide 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.
Dofetilide may be tested according to a variety of international standards, such as European Pharmacopoeia (Dofetilide EP), Dofetilide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dofetilide USP).
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