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.

2010

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 the permission to manufacture medicinal pereparations on Line 1 and also a GMP certificate.

2011
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V druhé polovině roku začínáme vyrábět první komerční šarže léčivých přípravků. Pracujeme na zprovoznění další linky.

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

2012
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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 distrubution of our products to United States of America. 

2015
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Another succesful audity 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.

2017

Approval of investigational medicinal products

Another inspection by SUKL in February 2018, approved the extension of our production scope for investigational medicinal products.

2018

OHSAS certification

Based on a succesful  audit of our OHS management we received the OHSAS certificate.

2018