Synopsis
Synopsis
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JDMF
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EU WC
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KDMF
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NDC API
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VMF
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FDF Dossiers
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FDA Orange Book
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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
1. Betadex Sulfobutyl Ether Sodium
2. Captisol
3. Sbe-beta-cd
4. Sbe4-beta-cd
5. Sbe4-beta-cyclodextrin
6. Sulfobutyl Ether Beta-cyclodextrin
7. Sulfobutylether-beta-cyclodextrin
8. Sulfobutylether-betacd
9. Sulfurbutylether-beta-cyclodextrin
10. Sulphobutylether-betacd
1. Sulfobutyl Ether Beta-cyclodextrin
2. Sodiumsulphobutylether-beta-cyclodextrin
3. A880893
4. Beta-cyclodextrin Sulfobutyl Ether, Sodium Salts;sodium Sulphobutylether-beta-cyclodextrin
5. Sbe-afae'a Centa' Nota Inverted Exclamation Markafasa'a
6. Afae'adaggeratrade Markafa Centa Centasa Nota Em Leadera Inverted Exclamation Mark-cd
Molecular Weight | 1451.3 g/mol |
---|---|
Molecular Formula | C50H84Na2O41S2 |
Hydrogen Bond Donor Count | 19 |
Hydrogen Bond Acceptor Count | 41 |
Rotatable Bond Count | 17 |
Exact Mass | 1450.3724830 g/mol |
Monoisotopic Mass | 1450.3724830 g/mol |
Topological Polar Surface Area | 663 Ų |
Heavy Atom Count | 95 |
Formal Charge | 0 |
Complexity | 2460 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 35 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
Excipients
Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc. (See all compounds classified as Excipients.)
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36487
Submission : 2021-12-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34773
Submission : 2020-05-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30167
Submission : 2015-12-21
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12791
Submission : 1997-12-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36347
Submission : 2023-07-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29379
Submission : 2015-05-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29394
Submission : 2015-05-15
Status : Active
Type : IV
Certificate Number : R0-CEP 2021-025 - Rev 00
Issue Date : 2022-06-20
Type : Chemical
Substance Number : 2804
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37814
Submission : 2022-12-28
Status : Active
Type : IV
Certificate Number : CEP 2022-504 - Rev 00
Issue Date : 2024-07-03
Type : Chemical
Substance Number : 2804
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21922
Submission : 2008-08-29
Status : Active
Type : IV
Market Place
Reply
20 Aug 2024
Reply
21 Jan 2022
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
35
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 Sulfobutylether-β-Cydodextrin (SBECD) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulfobutylether-β-Cydodextrin (SBECD), including repackagers and relabelers. The FDA regulates Sulfobutylether-β-Cydodextrin (SBECD) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulfobutylether-β-Cydodextrin (SBECD) 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 Sulfobutylether-β-Cydodextrin (SBECD) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulfobutylether-β-Cydodextrin (SBECD) supplier is an individual or a company that provides Sulfobutylether-β-Cydodextrin (SBECD) active pharmaceutical ingredient (API) or Sulfobutylether-β-Cydodextrin (SBECD) finished formulations upon request. The Sulfobutylether-β-Cydodextrin (SBECD) suppliers may include Sulfobutylether-β-Cydodextrin (SBECD) API manufacturers, exporters, distributors and traders.
click here to find a list of Sulfobutylether-β-Cydodextrin (SBECD) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulfobutylether-β-Cydodextrin (SBECD) DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulfobutylether-β-Cydodextrin (SBECD) active pharmaceutical ingredient (API) in detail. Different forms of Sulfobutylether-β-Cydodextrin (SBECD) DMFs exist exist since differing nations have different regulations, such as Sulfobutylether-β-Cydodextrin (SBECD) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulfobutylether-β-Cydodextrin (SBECD) DMF submitted to regulatory agencies in the US is known as a USDMF. Sulfobutylether-β-Cydodextrin (SBECD) USDMF includes data on Sulfobutylether-β-Cydodextrin (SBECD)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulfobutylether-β-Cydodextrin (SBECD) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulfobutylether-β-Cydodextrin (SBECD) suppliers with USDMF on PharmaCompass.
A Sulfobutylether-β-Cydodextrin (SBECD) CEP of the European Pharmacopoeia monograph is often referred to as a Sulfobutylether-β-Cydodextrin (SBECD) Certificate of Suitability (COS). The purpose of a Sulfobutylether-β-Cydodextrin (SBECD) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sulfobutylether-β-Cydodextrin (SBECD) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sulfobutylether-β-Cydodextrin (SBECD) to their clients by showing that a Sulfobutylether-β-Cydodextrin (SBECD) CEP has been issued for it. The manufacturer submits a Sulfobutylether-β-Cydodextrin (SBECD) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sulfobutylether-β-Cydodextrin (SBECD) CEP holder for the record. Additionally, the data presented in the Sulfobutylether-β-Cydodextrin (SBECD) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sulfobutylether-β-Cydodextrin (SBECD) DMF.
A Sulfobutylether-β-Cydodextrin (SBECD) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sulfobutylether-β-Cydodextrin (SBECD) 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 Sulfobutylether-β-Cydodextrin (SBECD) suppliers with CEP (COS) on PharmaCompass.
Sulfobutylether-β-Cydodextrin (SBECD) 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 Sulfobutylether-β-Cydodextrin (SBECD) 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 Sulfobutylether-β-Cydodextrin (SBECD) GMP manufacturer or Sulfobutylether-β-Cydodextrin (SBECD) GMP API supplier for your needs.
A Sulfobutylether-β-Cydodextrin (SBECD) CoA (Certificate of Analysis) is a formal document that attests to Sulfobutylether-β-Cydodextrin (SBECD)'s compliance with Sulfobutylether-β-Cydodextrin (SBECD) specifications and serves as a tool for batch-level quality control.
Sulfobutylether-β-Cydodextrin (SBECD) CoA mostly includes findings from lab analyses of a specific batch. For each Sulfobutylether-β-Cydodextrin (SBECD) 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.
Sulfobutylether-β-Cydodextrin (SBECD) may be tested according to a variety of international standards, such as European Pharmacopoeia (Sulfobutylether-β-Cydodextrin (SBECD) EP), Sulfobutylether-β-Cydodextrin (SBECD) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sulfobutylether-β-Cydodextrin (SBECD) USP).