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