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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 20MG
USFDA APPLICATION NUMBER - 16273
DOSAGE - TABLET;ORAL - 40MG
USFDA APPLICATION NUMBER - 16273
DOSAGE - TABLET;ORAL - 80MG
USFDA APPLICATION NUMBER - 16273
DOSAGE - INJECTABLE;INJECTION - 10MG/ML **Fed...DOSAGE - INJECTABLE;INJECTION - 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18579
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
33
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 Vesix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vesix, including repackagers and relabelers. The FDA regulates Vesix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vesix 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 Vesix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vesix supplier is an individual or a company that provides Vesix active pharmaceutical ingredient (API) or Vesix finished formulations upon request. The Vesix suppliers may include Vesix API manufacturers, exporters, distributors and traders.
click here to find a list of Vesix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vesix DMF (Drug Master File) is a document detailing the whole manufacturing process of Vesix active pharmaceutical ingredient (API) in detail. Different forms of Vesix DMFs exist exist since differing nations have different regulations, such as Vesix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vesix DMF submitted to regulatory agencies in the US is known as a USDMF. Vesix USDMF includes data on Vesix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vesix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vesix 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 Vesix Drug Master File in Japan (Vesix JDMF) empowers Vesix 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 Vesix JDMF during the approval evaluation for pharmaceutical products. At the time of Vesix 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 Vesix suppliers with JDMF on PharmaCompass.
A Vesix CEP of the European Pharmacopoeia monograph is often referred to as a Vesix Certificate of Suitability (COS). The purpose of a Vesix CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vesix EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vesix to their clients by showing that a Vesix CEP has been issued for it. The manufacturer submits a Vesix CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vesix CEP holder for the record. Additionally, the data presented in the Vesix CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vesix DMF.
A Vesix CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vesix 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 Vesix suppliers with CEP (COS) on PharmaCompass.
A Vesix written confirmation (Vesix WC) is an official document issued by a regulatory agency to a Vesix manufacturer, verifying that the manufacturing facility of a Vesix active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vesix APIs or Vesix finished pharmaceutical products to another nation, regulatory agencies frequently require a Vesix WC (written confirmation) as part of the regulatory process.
click here to find a list of Vesix 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 Vesix as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vesix 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 Vesix 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 Vesix and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vesix NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vesix suppliers with NDC on PharmaCompass.
Vesix 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 Vesix 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 Vesix GMP manufacturer or Vesix GMP API supplier for your needs.
A Vesix CoA (Certificate of Analysis) is a formal document that attests to Vesix's compliance with Vesix specifications and serves as a tool for batch-level quality control.
Vesix CoA mostly includes findings from lab analyses of a specific batch. For each Vesix 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.
Vesix may be tested according to a variety of international standards, such as European Pharmacopoeia (Vesix EP), Vesix JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vesix USP).
