Synopsis
Synopsis
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CEP/COS
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EU WC
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KDMF
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NDC API
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Molecular Weight | 690.7 g/mol |
---|---|
Molecular Formula | C26H26N8O11S2 |
XLogP3 | -0.8 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 16 |
Rotatable Bond Count | 8 |
Exact Mass | 690.11624602 g/mol |
Monoisotopic Mass | 690.11624602 g/mol |
Topological Polar Surface Area | 303 A^2 |
Heavy Atom Count | 47 |
Formal Charge | 0 |
Complexity | 1670 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 2 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20446
Submission : 2007-05-03
Status : Inactive
Type : II
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ABOUT THIS PAGE
A Ceftobiprole Medocaril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ceftobiprole Medocaril, including repackagers and relabelers. The FDA regulates Ceftobiprole Medocaril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ceftobiprole Medocaril 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 Ceftobiprole Medocaril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ceftobiprole Medocaril supplier is an individual or a company that provides Ceftobiprole Medocaril active pharmaceutical ingredient (API) or Ceftobiprole Medocaril finished formulations upon request. The Ceftobiprole Medocaril suppliers may include Ceftobiprole Medocaril API manufacturers, exporters, distributors and traders.
click here to find a list of Ceftobiprole Medocaril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ceftobiprole Medocaril DMF (Drug Master File) is a document detailing the whole manufacturing process of Ceftobiprole Medocaril active pharmaceutical ingredient (API) in detail. Different forms of Ceftobiprole Medocaril DMFs exist exist since differing nations have different regulations, such as Ceftobiprole Medocaril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ceftobiprole Medocaril DMF submitted to regulatory agencies in the US is known as a USDMF. Ceftobiprole Medocaril USDMF includes data on Ceftobiprole Medocaril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ceftobiprole Medocaril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ceftobiprole Medocaril suppliers with USDMF on PharmaCompass.
Ceftobiprole Medocaril 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 Ceftobiprole Medocaril 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 Ceftobiprole Medocaril GMP manufacturer or Ceftobiprole Medocaril GMP API supplier for your needs.
A Ceftobiprole Medocaril CoA (Certificate of Analysis) is a formal document that attests to Ceftobiprole Medocaril's compliance with Ceftobiprole Medocaril specifications and serves as a tool for batch-level quality control.
Ceftobiprole Medocaril CoA mostly includes findings from lab analyses of a specific batch. For each Ceftobiprole Medocaril 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.
Ceftobiprole Medocaril may be tested according to a variety of international standards, such as European Pharmacopoeia (Ceftobiprole Medocaril EP), Ceftobiprole Medocaril JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ceftobiprole Medocaril USP).
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