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