Through our long experience in extremely diversified markets we gained an extensive familiarity in tackling complex business and regulatory challenges.
A high degree of flexibility, a light hierarchical organization and a quick reactivity of the decision makers also on the financial matters allows the group to quickly respond to clients, to market needs and to new projects.
This is specially important in the generic field, where knowledge and awareness of timing issues and filing/approval procedures is of paramount importance.
AMSA, COSMA and Clarochem Ireland are exclusively involved in API manufacturing, without any involvement in the finished dosage business.
This, together with complete financial independence of the group, puts the customer at ease for the lack of any potential conflict of interests.
Beside the generic API activities, we have a robust custom manufacturing capability and experience in both intermediates and APIs, demonstrated by a good track record of projects completed for our customers, including successful commercial launches of new chemical entities.
Deep knowledge of industrial and regulatory issues, expertise in process development and a wide range of complementary production scales, all in GMP, allow us to identify ideal and robust processes to carry the customer lead from medicinal chemistry through all the clinical phases, up to the final commercial production. A responsible approach on costs and efficiency, well developed during six decades of competition on the generic market, is applied also to the synthesis of new chemical entities since the beginning.