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