US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Furosemide 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 Furosemide manufacturer or Furosemide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Furosemide manufacturer or Furosemide supplier.
PharmaCompass also assists you with knowing the Furosemide API Price utilized in the formulation of products. Furosemide API Price is not always fixed or binding as the Furosemide Price is obtained through a variety of data sources. The Furosemide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Furosemide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Furosemide, including repackagers and relabelers. The FDA regulates Furosemide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Furosemide 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 Furosemide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Furosemide supplier is an individual or a company that provides Furosemide active pharmaceutical ingredient (API) or Furosemide finished formulations upon request. The Furosemide suppliers may include Furosemide API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Furosemide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Furosemide DMF (Drug Master File) is a document detailing the whole manufacturing process of Furosemide active pharmaceutical ingredient (API) in detail. Different forms of Furosemide DMFs exist exist since differing nations have different regulations, such as Furosemide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Furosemide DMF submitted to regulatory agencies in the US is known as a USDMF. Furosemide USDMF includes data on Furosemide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Furosemide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Furosemide Drug Master File in Japan (Furosemide JDMF) empowers Furosemide 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 Furosemide JDMF during the approval evaluation for pharmaceutical products. At the time of Furosemide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A Furosemide CEP of the European Pharmacopoeia monograph is often referred to as a Furosemide Certificate of Suitability (COS). The purpose of a Furosemide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Furosemide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Furosemide to their clients by showing that a Furosemide CEP has been issued for it. The manufacturer submits a Furosemide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Furosemide CEP holder for the record. Additionally, the data presented in the Furosemide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Furosemide DMF.
A Furosemide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Furosemide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Furosemide written confirmation (Furosemide WC) is an official document issued by a regulatory agency to a Furosemide manufacturer, verifying that the manufacturing facility of a Furosemide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Furosemide APIs or Furosemide finished pharmaceutical products to another nation, regulatory agencies frequently require a Furosemide WC (written confirmation) as part of the regulatory process.
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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 Furosemide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Furosemide 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 Furosemide 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 Furosemide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Furosemide NDC to their finished compounded human drug products, they may choose to do so.
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Furosemide 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 Furosemide 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 Furosemide GMP manufacturer or Furosemide GMP API supplier for your needs.
A Furosemide CoA (Certificate of Analysis) is a formal document that attests to Furosemide's compliance with Furosemide specifications and serves as a tool for batch-level quality control.
Furosemide CoA mostly includes findings from lab analyses of a specific batch. For each Furosemide 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.
Furosemide may be tested according to a variety of international standards, such as European Pharmacopoeia (Furosemide EP), Furosemide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Furosemide USP).