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PharmaCompass offers a list of Methylene Blue 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 Methylene Blue manufacturer or Methylene Blue supplier for your needs.
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A 3,7-Bis(dimethylamino)phenazathionium chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 3,7-Bis(dimethylamino)phenazathionium chloride, including repackagers and relabelers. The FDA regulates 3,7-Bis(dimethylamino)phenazathionium chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 3,7-Bis(dimethylamino)phenazathionium chloride 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 3,7-Bis(dimethylamino)phenazathionium chloride supplier is an individual or a company that provides 3,7-Bis(dimethylamino)phenazathionium chloride active pharmaceutical ingredient (API) or 3,7-Bis(dimethylamino)phenazathionium chloride finished formulations upon request. The 3,7-Bis(dimethylamino)phenazathionium chloride suppliers may include 3,7-Bis(dimethylamino)phenazathionium chloride API manufacturers, exporters, distributors and traders.
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A 3,7-Bis(dimethylamino)phenazathionium chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of 3,7-Bis(dimethylamino)phenazathionium chloride active pharmaceutical ingredient (API) in detail. Different forms of 3,7-Bis(dimethylamino)phenazathionium chloride DMFs exist exist since differing nations have different regulations, such as 3,7-Bis(dimethylamino)phenazathionium chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 3,7-Bis(dimethylamino)phenazathionium chloride DMF submitted to regulatory agencies in the US is known as a USDMF. 3,7-Bis(dimethylamino)phenazathionium chloride USDMF includes data on 3,7-Bis(dimethylamino)phenazathionium chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 3,7-Bis(dimethylamino)phenazathionium chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A 3,7-Bis(dimethylamino)phenazathionium chloride CEP of the European Pharmacopoeia monograph is often referred to as a 3,7-Bis(dimethylamino)phenazathionium chloride Certificate of Suitability (COS). The purpose of a 3,7-Bis(dimethylamino)phenazathionium chloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 3,7-Bis(dimethylamino)phenazathionium chloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 3,7-Bis(dimethylamino)phenazathionium chloride to their clients by showing that a 3,7-Bis(dimethylamino)phenazathionium chloride CEP has been issued for it. The manufacturer submits a 3,7-Bis(dimethylamino)phenazathionium chloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a 3,7-Bis(dimethylamino)phenazathionium chloride CEP holder for the record. Additionally, the data presented in the 3,7-Bis(dimethylamino)phenazathionium chloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 3,7-Bis(dimethylamino)phenazathionium chloride DMF.
A 3,7-Bis(dimethylamino)phenazathionium chloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 3,7-Bis(dimethylamino)phenazathionium chloride 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 3,7-Bis(dimethylamino)phenazathionium chloride written confirmation (3,7-Bis(dimethylamino)phenazathionium chloride WC) is an official document issued by a regulatory agency to a 3,7-Bis(dimethylamino)phenazathionium chloride manufacturer, verifying that the manufacturing facility of a 3,7-Bis(dimethylamino)phenazathionium chloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 3,7-Bis(dimethylamino)phenazathionium chloride APIs or 3,7-Bis(dimethylamino)phenazathionium chloride finished pharmaceutical products to another nation, regulatory agencies frequently require a 3,7-Bis(dimethylamino)phenazathionium chloride 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 3,7-Bis(dimethylamino)phenazathionium chloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 3,7-Bis(dimethylamino)phenazathionium chloride 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 3,7-Bis(dimethylamino)phenazathionium chloride 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 3,7-Bis(dimethylamino)phenazathionium chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 3,7-Bis(dimethylamino)phenazathionium chloride NDC to their finished compounded human drug products, they may choose to do so.
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3,7-Bis(dimethylamino)phenazathionium chloride 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 3,7-Bis(dimethylamino)phenazathionium chloride 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 3,7-Bis(dimethylamino)phenazathionium chloride GMP manufacturer or 3,7-Bis(dimethylamino)phenazathionium chloride GMP API supplier for your needs.
A 3,7-Bis(dimethylamino)phenazathionium chloride CoA (Certificate of Analysis) is a formal document that attests to 3,7-Bis(dimethylamino)phenazathionium chloride's compliance with 3,7-Bis(dimethylamino)phenazathionium chloride specifications and serves as a tool for batch-level quality control.
3,7-Bis(dimethylamino)phenazathionium chloride CoA mostly includes findings from lab analyses of a specific batch. For each 3,7-Bis(dimethylamino)phenazathionium chloride 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.
3,7-Bis(dimethylamino)phenazathionium chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (3,7-Bis(dimethylamino)phenazathionium chloride EP), 3,7-Bis(dimethylamino)phenazathionium chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (3,7-Bis(dimethylamino)phenazathionium chloride USP).
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