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