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USDMF
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PharmaCompass offers a list of Sulfobutylether-β-Cydodextrin (SBECD) 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 Sulfobutylether-β-Cydodextrin (SBECD) manufacturer or Sulfobutylether-β-Cydodextrin (SBECD) supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sulfobutylether-β-Cydodextrin (SBECD) manufacturer or Sulfobutylether-β-Cydodextrin (SBECD) supplier.
PharmaCompass also assists you with knowing the Sulfobutylether-β-Cydodextrin (SBECD) API Price utilized in the formulation of products. Sulfobutylether-β-Cydodextrin (SBECD) API Price is not always fixed or binding as the Sulfobutylether-β-Cydodextrin (SBECD) Price is obtained through a variety of data sources. The Sulfobutylether-β-Cydodextrin (SBECD) Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Captisol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Captisol, including repackagers and relabelers. The FDA regulates Captisol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Captisol 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 Captisol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Captisol supplier is an individual or a company that provides Captisol active pharmaceutical ingredient (API) or Captisol finished formulations upon request. The Captisol suppliers may include Captisol API manufacturers, exporters, distributors and traders.
click here to find a list of Captisol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Captisol DMF (Drug Master File) is a document detailing the whole manufacturing process of Captisol active pharmaceutical ingredient (API) in detail. Different forms of Captisol DMFs exist exist since differing nations have different regulations, such as Captisol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Captisol DMF submitted to regulatory agencies in the US is known as a USDMF. Captisol USDMF includes data on Captisol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Captisol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Captisol suppliers with USDMF on PharmaCompass.
A Captisol CEP of the European Pharmacopoeia monograph is often referred to as a Captisol Certificate of Suitability (COS). The purpose of a Captisol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Captisol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Captisol to their clients by showing that a Captisol CEP has been issued for it. The manufacturer submits a Captisol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Captisol CEP holder for the record. Additionally, the data presented in the Captisol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Captisol DMF.
A Captisol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Captisol CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Captisol suppliers with CEP (COS) on PharmaCompass.
Captisol 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 Captisol 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 Captisol GMP manufacturer or Captisol GMP API supplier for your needs.
A Captisol CoA (Certificate of Analysis) is a formal document that attests to Captisol's compliance with Captisol specifications and serves as a tool for batch-level quality control.
Captisol CoA mostly includes findings from lab analyses of a specific batch. For each Captisol 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.
Captisol may be tested according to a variety of international standards, such as European Pharmacopoeia (Captisol EP), Captisol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Captisol USP).
