Moving towards full-scale API manufacturing
CARBOGEN AMCIS has over 10 years of experience in the supply of APIs for clinical trials and commercial production and is specialized in the multi-step cGMP manufacture of low volume APIs (20 kg to 2000 kg). The goal is to supply our clients with market-ready quantities of APIs including drug mater files and regulatory documentation.
As part of the Dishman Group, CARBOGEN AMCIS offers the option of internal technology transfer to FDA approved large scale production facilities in India.
An efficient technology transfer process is the key for a successful transfer. This has already been proven by the transfer of several complex, multi-step processes under both GMP and nonGMP conditions to Dishman India.
With an established three-stage procedure consisting of 1. initiation; 2. piloting and 3. sign-off, a specialist team with clearly defined responsibilities throughout the transfer process relies on frequent communication between the sites to overcome the possible linguistic and cultural barriers.