From Idea to Molecule and Finished Drug
PAM-Preparations LLC (a resident of biopharmaceutical Alliance of competences Park of Active Molecules) has received a license for production of drugs – finished pharmaceutical forms (capsules).
It is of note, that Alliance already has experience of such manufacture. Its resident, a Scientific-Production company Medbiopharm is performing capsulation of functional food supplements. Although these procedures are quite similar in technological terms, it took over one year to prepare for obtaining a license for production of the drug.
SPC Medbiopharm received a license for manufacture of pharmaceutically active raw materials for further production of drugs. Now the alliance has a permission to develop and manufacture pharmaceutical drugs at its facilities. That means that it can work according to full cycle – from idea to finished product. The license may be widened to provide an opportunity to organize manufacture of tablet preparations.
Recently the number of original drugs developed in AC PAM institutions has been significantly increased. They successfully passed preclinical trials. Some of them are already at the stage of clinical trials, others have just reached that stage. This is related to the need of obtaining a license for production of drugs.