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ABOUT THIS PAGE
A Monomethyl Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Monomethyl Fumarate, including repackagers and relabelers. The FDA regulates Monomethyl Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Monomethyl Fumarate 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 Monomethyl Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Monomethyl Fumarate supplier is an individual or a company that provides Monomethyl Fumarate active pharmaceutical ingredient (API) or Monomethyl Fumarate finished formulations upon request. The Monomethyl Fumarate suppliers may include Monomethyl Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Monomethyl Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Monomethyl Fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Monomethyl Fumarate active pharmaceutical ingredient (API) in detail. Different forms of Monomethyl Fumarate DMFs exist exist since differing nations have different regulations, such as Monomethyl Fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Monomethyl Fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Monomethyl Fumarate USDMF includes data on Monomethyl Fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Monomethyl Fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Monomethyl Fumarate suppliers with USDMF on PharmaCompass.
A Monomethyl Fumarate written confirmation (Monomethyl Fumarate WC) is an official document issued by a regulatory agency to a Monomethyl Fumarate manufacturer, verifying that the manufacturing facility of a Monomethyl Fumarate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Monomethyl Fumarate APIs or Monomethyl Fumarate finished pharmaceutical products to another nation, regulatory agencies frequently require a Monomethyl Fumarate WC (written confirmation) as part of the regulatory process.
click here to find a list of Monomethyl Fumarate 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 Monomethyl Fumarate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Monomethyl Fumarate 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 Monomethyl Fumarate 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 Monomethyl Fumarate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Monomethyl Fumarate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Monomethyl Fumarate suppliers with NDC on PharmaCompass.
Monomethyl Fumarate 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 Monomethyl Fumarate 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 Monomethyl Fumarate GMP manufacturer or Monomethyl Fumarate GMP API supplier for your needs.
A Monomethyl Fumarate CoA (Certificate of Analysis) is a formal document that attests to Monomethyl Fumarate's compliance with Monomethyl Fumarate specifications and serves as a tool for batch-level quality control.
Monomethyl Fumarate CoA mostly includes findings from lab analyses of a specific batch. For each Monomethyl Fumarate 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.
Monomethyl Fumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Monomethyl Fumarate EP), Monomethyl Fumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Monomethyl Fumarate USP).
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