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