CPL SACHSE is an established contract developer and manufacturer (CMO) of organic, active pharmaceutical ingredients (APIs) for human and veterinary use. We routinely produce APIs and selected intermediates from the milligram to kilogram range (approx. 40 kg) under cGMP (ICH Q7). We are regularly audited by our customers and the responsible German authority. Our most recent inspection by the US-FDA took place in June 2017.
Currently, our range of substances does not include any hormones/steroids, cephalosporins/ penicillins or cytostatics.
In addition to API production, we provide all analytical, pharmaceutical and regulatory services required to develop and submit drug substances and drug products for marketing approval.