Apertus can help with your API manufacturing needs by:

• Sourcing and vetting overseas API suppliers
• Synthesizing intermediates, drug substances or building blocks on mg to kg scale
• Providing route selection and optimization services
• cGMP synthesis of targets for pre-clinical and clinical studies
• Documenting process design work for regulatory filings
• Performing validation batches and writing associated validation reports
• Conducting stability and forced degradation studies
• Developing stability-indicating analytical methods
• Identifying and synthesizing process impurities and degradants
• Manufacturing your NCE for delivery to your selected formulator
• Providing tech transfer support if a larger manufacturing facility is required

In addition Apertus can help in specialty areas such as:

• Potent compound synthesis
• Controlled substance manufacturing (Schedule II-V)
• Synthesis of synthetic and semi-synthetic opioids
• Development of process chromatography or batch crystallization methods