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