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PharmaCompass offers a list of Dimethyl Fumarate 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 Dimethyl Fumarate manufacturer or Dimethyl Fumarate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dimethyl Fumarate manufacturer or Dimethyl Fumarate supplier.
PharmaCompass also assists you with knowing the Dimethyl Fumarate API Price utilized in the formulation of products. Dimethyl Fumarate API Price is not always fixed or binding as the Dimethyl Fumarate Price is obtained through a variety of data sources. The Dimethyl Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dimethyl Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dimethyl Fumarate, including repackagers and relabelers. The FDA regulates Dimethyl Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dimethyl 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 Dimethyl Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dimethyl Fumarate supplier is an individual or a company that provides Dimethyl Fumarate active pharmaceutical ingredient (API) or Dimethyl Fumarate finished formulations upon request. The Dimethyl Fumarate suppliers may include Dimethyl Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Dimethyl Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dimethyl Fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dimethyl Fumarate active pharmaceutical ingredient (API) in detail. Different forms of Dimethyl Fumarate DMFs exist exist since differing nations have different regulations, such as Dimethyl Fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dimethyl Fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Dimethyl Fumarate USDMF includes data on Dimethyl Fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dimethyl Fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dimethyl Fumarate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dimethyl Fumarate Drug Master File in Korea (Dimethyl Fumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dimethyl Fumarate. The MFDS reviews the Dimethyl Fumarate KDMF as part of the drug registration process and uses the information provided in the Dimethyl Fumarate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dimethyl Fumarate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dimethyl Fumarate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dimethyl Fumarate suppliers with KDMF on PharmaCompass.
A Dimethyl Fumarate written confirmation (Dimethyl Fumarate WC) is an official document issued by a regulatory agency to a Dimethyl Fumarate manufacturer, verifying that the manufacturing facility of a Dimethyl Fumarate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dimethyl Fumarate APIs or Dimethyl Fumarate finished pharmaceutical products to another nation, regulatory agencies frequently require a Dimethyl Fumarate WC (written confirmation) as part of the regulatory process.
click here to find a list of Dimethyl 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 Dimethyl Fumarate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dimethyl 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 Dimethyl 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 Dimethyl Fumarate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dimethyl Fumarate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dimethyl Fumarate suppliers with NDC on PharmaCompass.
Dimethyl 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 Dimethyl 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 Dimethyl Fumarate GMP manufacturer or Dimethyl Fumarate GMP API supplier for your needs.
A Dimethyl Fumarate CoA (Certificate of Analysis) is a formal document that attests to Dimethyl Fumarate's compliance with Dimethyl Fumarate specifications and serves as a tool for batch-level quality control.
Dimethyl Fumarate CoA mostly includes findings from lab analyses of a specific batch. For each Dimethyl 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.
Dimethyl Fumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dimethyl Fumarate EP), Dimethyl Fumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dimethyl Fumarate USP).
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