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