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