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