About the Company
Our Major Milestones
Major Milestones in our History
Establishment of the Company
The company was officially founded in August 2010. The first 10 employees started to work for the new company. We commenced the process of putting production lines in operation as well as construction work in the control laboratory, stability room, visual inspection and packaging premises.
Extension of the Team of Staff
We managed to put Production Line 2 in operation, including a terminal sterilizer. We successfully went through another audit by the State Institute for Drug Control, and we obtained an approval required for manufacturing of pharmaceutical preparations using Production Line 2 as well as a GMP certificate
In autumn we completed the process of construction of the power centre. Having obtained a power production licence, we started to produce and distribute process steam, heating water and power required for operation of the company’s production lines. Also we expanded in terms of the number of our employees – by the end of 2012 there were 105 of us.
Collaboration on research of a new active substance
We started to collaborate on research of a new active substance for the treatment of cancers.
Commencement of Production of Commercial Pharmaceuticals
We put the first cytostatic injection production line in operation. We were successfully audited by the State Institute for Drug Control. We obtained an approval required for manufacturing of pharmaceutical preparations using Production Line 1 as well as a GMP certificate.
In the second half of the year we started production of the first commercial batches and started working on putting another production line in operation.
Preparing for FDA
We started to prepare for an audit to be conducted by FDA, the US regulatory authority, which would allow us to manufacture also for the US market.
Our new warehouses of pharmaceutical preparations were successfully audited by the State Institute for Drug Control.
Approval of investigational medicinal products
In February 2018 the State Institute for Drug Control (SUKL) approved the extension of the scope of the production for investigational medicinal products.