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PharmaCompass offers a list of Mifepristone 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 Mifepristone manufacturer or Mifepristone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mifepristone manufacturer or Mifepristone supplier.
PharmaCompass also assists you with knowing the Mifepristone API Price utilized in the formulation of products. Mifepristone API Price is not always fixed or binding as the Mifepristone Price is obtained through a variety of data sources. The Mifepristone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mifepristone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mifepristone, including repackagers and relabelers. The FDA regulates Mifepristone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mifepristone 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 Mifepristone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mifepristone supplier is an individual or a company that provides Mifepristone active pharmaceutical ingredient (API) or Mifepristone finished formulations upon request. The Mifepristone suppliers may include Mifepristone API manufacturers, exporters, distributors and traders.
click here to find a list of Mifepristone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mifepristone DMF (Drug Master File) is a document detailing the whole manufacturing process of Mifepristone active pharmaceutical ingredient (API) in detail. Different forms of Mifepristone DMFs exist exist since differing nations have different regulations, such as Mifepristone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mifepristone DMF submitted to regulatory agencies in the US is known as a USDMF. Mifepristone USDMF includes data on Mifepristone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mifepristone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mifepristone suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Mifepristone Drug Master File in Japan (Mifepristone JDMF) empowers Mifepristone API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Mifepristone JDMF during the approval evaluation for pharmaceutical products. At the time of Mifepristone JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Mifepristone suppliers with JDMF on PharmaCompass.
A Mifepristone written confirmation (Mifepristone WC) is an official document issued by a regulatory agency to a Mifepristone manufacturer, verifying that the manufacturing facility of a Mifepristone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mifepristone APIs or Mifepristone finished pharmaceutical products to another nation, regulatory agencies frequently require a Mifepristone WC (written confirmation) as part of the regulatory process.
click here to find a list of Mifepristone 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 Mifepristone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mifepristone 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 Mifepristone 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 Mifepristone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mifepristone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mifepristone suppliers with NDC on PharmaCompass.
Mifepristone 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 Mifepristone 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 Mifepristone GMP manufacturer or Mifepristone GMP API supplier for your needs.
A Mifepristone CoA (Certificate of Analysis) is a formal document that attests to Mifepristone's compliance with Mifepristone specifications and serves as a tool for batch-level quality control.
Mifepristone CoA mostly includes findings from lab analyses of a specific batch. For each Mifepristone 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.
Mifepristone may be tested according to a variety of international standards, such as European Pharmacopoeia (Mifepristone EP), Mifepristone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mifepristone USP).