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