Sourcing the Right Manufacturing Facilities
ChemWerth has access to over 500 APIs from more than 30 manufacturing facilities in the U.S., Europe, India and China. ChemWerth’s regulatory teams ensure these facilities are cGMP compliant. All of our commercial API manufacturers have passed FDA inspections, and are classified as Acceptable, providing distinct and unique capabilities to produce high quality, competitively-priced APIs in the following strategic areas:
- Inorganic Compounds
- Organometalic Compounds
- Complex Organic Compounds –
We can provide you with almost limitless options.
Custom Development – ChemWerth can offer a unique research environment for custom synthesis and process development. ChemWerth’s expert staff and laboratory in collaboration with highly respected outside resources offers the skills and experience to expedite the development process.
Custom Manufacturing – Working on an Exclusive Basis with a number of domestic and international cGMP manufacturers, ChemWerth can supply those difficult to produce generics and new pharmaceuticals in a time frame that enables quick market entry.
Custom Production Facilities – Whether your requirements demand large-scale fermentation capacity or clean room scale synthesis, ChemWerth has the range of capabilities to satisfy your needs. Should your requirements demand it, experienced engineers can design and build a facility quickly and efficiently. Through ChemWerth’s own laboratory, we can provide analytical services from methods development to methods validation. All projects are conducted under cGMP conditions and are supported with DMF filings or product registration.