Synopsis
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![Mafodotin [Usan]](https://www.pharmacompass.com/image/drug/71300933.png)
1. Schembl13342952
2. Dtxsid90235521
| Molecular Weight | 925.2 g/mol |
|---|---|
| Molecular Formula | C49H76N6O11 |
| XLogP3 | 4.6 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 11 |
| Rotatable Bond Count | 27 |
| Exact Mass | 924.55720726 g/mol |
| Monoisotopic Mass | 924.55720726 g/mol |
| Topological Polar Surface Area | 212 Ų |
| Heavy Atom Count | 66 |
| Formal Charge | 0 |
| Complexity | 1680 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 8 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
No approved indication.
Selectively targets cancer cells expressing mutant epidermal growth factor receptor (EGFR) vIII or over expressing wild type EGFR. Depatuxizumab mafodotin acts on these cells to inhibit microtuble polymerization thus disrupting mitosis and vesicular trafficking
Depatuxizumab is a chimeric monoclonal antibody for EGFR which is linked to monomethyl aurastatin F via a maleimidocaproyl linker (mafodotin). Once delivered to the cancer cell, the mafodotin component is able to bind to tubulin and inhibit the exchange of GDP for GTP necessary for the polymerization of tubulin subunits to form microtubules. The inhibition of microtubule polymerization disrupts mitosis and interferes with vesicle trafficking in the cancer cell.
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ABOUT THIS PAGE
A Mafodotin [Usan] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mafodotin [Usan], including repackagers and relabelers. The FDA regulates Mafodotin [Usan] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mafodotin [Usan] 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 Mafodotin [Usan] supplier is an individual or a company that provides Mafodotin [Usan] active pharmaceutical ingredient (API) or Mafodotin [Usan] finished formulations upon request. The Mafodotin [Usan] suppliers may include Mafodotin [Usan] API manufacturers, exporters, distributors and traders.
click here to find a list of Mafodotin [Usan] suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mafodotin [Usan] DMF (Drug Master File) is a document detailing the whole manufacturing process of Mafodotin [Usan] active pharmaceutical ingredient (API) in detail. Different forms of Mafodotin [Usan] DMFs exist exist since differing nations have different regulations, such as Mafodotin [Usan] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mafodotin [Usan] DMF submitted to regulatory agencies in the US is known as a USDMF. Mafodotin [Usan] USDMF includes data on Mafodotin [Usan]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mafodotin [Usan] USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mafodotin [Usan] suppliers with USDMF on PharmaCompass.
Mafodotin [Usan] 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 Mafodotin [Usan] 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 Mafodotin [Usan] GMP manufacturer or Mafodotin [Usan] GMP API supplier for your needs.
A Mafodotin [Usan] CoA (Certificate of Analysis) is a formal document that attests to Mafodotin [Usan]'s compliance with Mafodotin [Usan] specifications and serves as a tool for batch-level quality control.
Mafodotin [Usan] CoA mostly includes findings from lab analyses of a specific batch. For each Mafodotin [Usan] 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.
Mafodotin [Usan] may be tested according to a variety of international standards, such as European Pharmacopoeia (Mafodotin [Usan] EP), Mafodotin [Usan] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mafodotin [Usan] USP).
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