See the DrugPatentWatch profile for Icatibant
Which companies make icatibant (or its impurities) and where do impurities come from?
“Icatibant impurity” usually refers to trace related substances that can form during drug manufacture, degradation, or storage, and are characterized for quality control. The best way to identify likely impurity sources is to look at:
- Manufacturers of icatibant drug substance (API) and drug product (finished formulation).
- Contract manufacturing organizations (CMOs) that produce icatibant batches under quality agreements.
- Suppliers of reference standards (impurities/related substances) used for HPLC/LC method development and routine release testing.
However, your question asks specifically for “impurity manufacturers,” and the provided information here does not name any specific companies or list any manufacturers of particular icatibant impurities.
How are icatibant impurities typically obtained for testing (reference standards)?
In practice, “impurity manufacturers” are often vendors that supply analytical reference standards for:
- Specific named related substances (if disclosed in compendial or regulatory documentation), and/or
- Generic impurity mixtures or characterization lots used to validate methods.
These products are commonly sold to QA labs and CROs for method development, stability studies, and release testing. Exact suppliers depend on the specific impurity identity (the chemical name/structure, CAS, or dossier-defined label).
What I need from you to name the right impurity makers
To produce a useful list of manufacturers, I need at least one of the following:
- The impurity name as written in your specifications (e.g., “Impurity A/B,” “related substance X”), or
- A CAS number, or
- The manufacturer’s/filing’s impurity identifier (ICH nomenclature), or
- The icatibant product you mean (strength and dosage form) and the regulatory source (if you have it).
If you meant “companies that make icatibant API” (not the impurities themselves)
Some users search this way because impurity suppliers aren’t marketed explicitly. If you confirm you want icatibant API manufacturers, I can narrow the search to API producers and list typical impurity providers only where they are tied to API reference standards or characterization work.
Quick clarification
Which exact impurity do you mean?
- Provide the impurity label/name (or CAS), and whether you want a supplier for a reference standard, an impurity intermediate for synthesis, or the API-quality impurity profile from a particular manufacturer.
Sources: None provided in the prompt.