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