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 quality control laboratory, a stability room, and visual inspection and packaging premises.
Manufacture of commercial products
Our first manufacturing line for cytostatic injections was put in operation. We were approved by SUKL, the Czech regulation authority and received both the permission to manufacture medicinal preparations on Line 1 and a GMP certificate.
Extension of the Team
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 construction process of our new 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.
Preparation for FDA
We are getting ready for a FDA audit that should enable the distribution of our products to United States of America.
Another succesful audit by our Czech authority, SUKL. Our new warehouses for medical preparations were approved.
Collaboration on research of a new active substance
We started to collaborate on the research of a new active substance for the treatment of cancers.
Approval of investigational medicinal products
Another inspection by SUKL in February 2018 approved the extension of our production scope for investigational medicinal products.
Based on a succesful audit of our OHS management we received the OHSAS certificate.
Approval of liquid investigational medicinal products
In January 2019, we got approved for production of liquid investigational medicinal products. Our company is thus approved both for lyophilized and liquid investigational and commercially manufactured medicinal products.