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