Since 1967, branded and generic pharmaceutical industries have been relying on Angelini Fine Chemicals to accelerate their R&D portfolio to the pharmaceutical market.
With demonstrated success in API Manufacturing and world-class capabilities in niche and high-barrier-to-entry technologies, Angelini Fine Chemicals supports the chemical development and cGMP manufacture of complex APIs. Qualified team of synthetic and analytical chemists are committed to delivering focused solutions to your API manufacturing challenges, complemented by our highly experienced regulatory professionals and supply chain experts to ensure all aspects of your API project are handled with expert care. Angelini custom development and manufacturing capabilities include:
- Route selection
- Process development and optimization (early to late stage, small to large scale)
- Analytical development and validation
- Clinical supply
- Manufacturing pilot, pre-validation, validation and commercial batches
- Synthesis and purification of analytical reference standards
- ICH stability studies
- Safety and toxicology assessments
- Preparing DMF and CEP support documentation
Click here to download the APIs list.