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