GMP manufacturing
Our expertise lies in developing and validating API processes, with facilities approved by US FDA and Health Canada. We offer flexible, high-quality solutions for complex chemical challenges.
Our capabilities
Advanced facilities
Small to large scale GMP kilo laboratories for (grams to kilo) scale-up to 60L, and manufacturing suites for volumes up to 2000L.
Specialised equipment
Cryogenic, hydrogenation, and chromatography capabilities, including Biotage™ systems and high-pressure preparatory liquid chromatography (Prep HPLC).
Chemical transformations
Expertise includes reductive amination, organometallics, halogenations, reductions, peptide chemistry and hydrogenation.
Stability studies
cGMP, ICH compliant studies for various conditions and forms.
Regulatory expertise
Assistance with CMC and DMF filings.
