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JDMF
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KDMF
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| Molecular Weight | 1135.0 g/mol |
|---|---|
| Molecular Formula | C42H70O35 |
| XLogP3 | -15 |
| Hydrogen Bond Donor Count | 21 |
| Hydrogen Bond Acceptor Count | 35 |
| Rotatable Bond Count | 7 |
| Exact Mass | 1134.3697639 g/mol |
| Monoisotopic Mass | 1134.3697639 g/mol |
| Topological Polar Surface Area | 554 Ų |
| Heavy Atom Count | 77 |
| Formal Charge | 0 |
| Complexity | 1480 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 21 |
| Undefined Atom Stereocenter Count | 14 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39536
Submission : 2024-02-14
Status : Active
Type : IV
Certificate Number : R0-CEP 2002-130 - Rev 00
Issue Date : 2006-06-21
Type : Chemical
Substance Number : 1070
Status : Expired
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USDMF
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API Imports and Exports
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Average Price (USD/KGS) |
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INTERMEDIATES SUPPLIERS
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Betadex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betadex, including repackagers and relabelers. The FDA regulates Betadex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betadex API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Betadex supplier is an individual or a company that provides Betadex active pharmaceutical ingredient (API) or Betadex finished formulations upon request. The Betadex suppliers may include Betadex API manufacturers, exporters, distributors and traders.
click here to find a list of Betadex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betadex DMF (Drug Master File) is a document detailing the whole manufacturing process of Betadex active pharmaceutical ingredient (API) in detail. Different forms of Betadex DMFs exist exist since differing nations have different regulations, such as Betadex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betadex DMF submitted to regulatory agencies in the US is known as a USDMF. Betadex USDMF includes data on Betadex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betadex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betadex suppliers with USDMF on PharmaCompass.
A Betadex CEP of the European Pharmacopoeia monograph is often referred to as a Betadex Certificate of Suitability (COS). The purpose of a Betadex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betadex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betadex to their clients by showing that a Betadex CEP has been issued for it. The manufacturer submits a Betadex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betadex CEP holder for the record. Additionally, the data presented in the Betadex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betadex DMF.
A Betadex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betadex 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 Betadex suppliers with CEP (COS) on PharmaCompass.
Betadex 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 Betadex 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 Betadex GMP manufacturer or Betadex GMP API supplier for your needs.
A Betadex CoA (Certificate of Analysis) is a formal document that attests to Betadex's compliance with Betadex specifications and serves as a tool for batch-level quality control.
Betadex CoA mostly includes findings from lab analyses of a specific batch. For each Betadex 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.
Betadex may be tested according to a variety of international standards, such as European Pharmacopoeia (Betadex EP), Betadex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betadex USP).
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