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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Trioxsalen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trioxsalen, including repackagers and relabelers. The FDA regulates Trioxsalen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trioxsalen 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 Trioxsalen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trioxsalen supplier is an individual or a company that provides Trioxsalen active pharmaceutical ingredient (API) or Trioxsalen finished formulations upon request. The Trioxsalen suppliers may include Trioxsalen API manufacturers, exporters, distributors and traders.
click here to find a list of Trioxsalen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trioxsalen DMF (Drug Master File) is a document detailing the whole manufacturing process of Trioxsalen active pharmaceutical ingredient (API) in detail. Different forms of Trioxsalen DMFs exist exist since differing nations have different regulations, such as Trioxsalen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trioxsalen DMF submitted to regulatory agencies in the US is known as a USDMF. Trioxsalen USDMF includes data on Trioxsalen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trioxsalen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trioxsalen suppliers with USDMF on PharmaCompass.
Trioxsalen 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 Trioxsalen 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 Trioxsalen GMP manufacturer or Trioxsalen GMP API supplier for your needs.
A Trioxsalen CoA (Certificate of Analysis) is a formal document that attests to Trioxsalen's compliance with Trioxsalen specifications and serves as a tool for batch-level quality control.
Trioxsalen CoA mostly includes findings from lab analyses of a specific batch. For each Trioxsalen 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.
Trioxsalen may be tested according to a variety of international standards, such as European Pharmacopoeia (Trioxsalen EP), Trioxsalen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trioxsalen USP).
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