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