US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Methadone 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 Methadone manufacturer or Methadone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methadone manufacturer or Methadone supplier.
PharmaCompass also assists you with knowing the Methadone API Price utilized in the formulation of products. Methadone API Price is not always fixed or binding as the Methadone Price is obtained through a variety of data sources. The Methadone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Methadone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methadone, including repackagers and relabelers. The FDA regulates Methadone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methadone 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 Methadone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methadone supplier is an individual or a company that provides Methadone active pharmaceutical ingredient (API) or Methadone finished formulations upon request. The Methadone suppliers may include Methadone API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Methadone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methadone DMF (Drug Master File) is a document detailing the whole manufacturing process of Methadone active pharmaceutical ingredient (API) in detail. Different forms of Methadone DMFs exist exist since differing nations have different regulations, such as Methadone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methadone DMF submitted to regulatory agencies in the US is known as a USDMF. Methadone USDMF includes data on Methadone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methadone USDMF is kept confidential to protect the manufacturer’s intellectual property.
CLICK HERE to find a list of Methadone suppliers with USDMF 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 Methadone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methadone 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 Methadone 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 Methadone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methadone NDC to their finished compounded human drug products, they may choose to do so.
CLICK HERE to find a list of Methadone suppliers with NDC on PharmaCompass.
Methadone 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 Methadone 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 Methadone GMP manufacturer or Methadone GMP API supplier for your needs.
A Methadone CoA (Certificate of Analysis) is a formal document that attests to Methadone's compliance with Methadone specifications and serves as a tool for batch-level quality control.
Methadone CoA mostly includes findings from lab analyses of a specific batch. For each Methadone 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.
Methadone may be tested according to a variety of international standards, such as European Pharmacopoeia (Methadone EP), Methadone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methadone USP).