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