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