The company completed the construction of the first plant and after a GMP inspection by the Bulgarian Drug Agency, obtained a manufacturing license. The company was already set on the path described by the Minister of Health Dr. Ilko Semerdzhiev in his speech at the opening of the first plant in Varna: “He who would have the fruit of recognition must climb the tree of quality.”
The event was attended by representatives of the Bulgarian political, academic, public and economic elite, and by a number of foreign guests.
The state-of-the-art plant equipment was supplied by Robert Bosch GmbH. The design and implementation of the clean areas was awarded to the British engineering company, MRC Systems Ltd. Two such areas exist in the company plants: for blister packaging – area with clean class D in accordance with Directive 91/359/ЕЕС, and an area for labeling of cephalosporin vials and ampoules – a “closed” area. The pure areas implemented by MRC Systems Ltd. include the special system MRC 1500 for wall covering; doors with magnet locking; vinyl roll for the floor; Armstrong clip-in-system for the ceiling; system of air barriers.
The line for primary and secondary packaging has a capacity of 5 million tablets and capsules per annum and the labeling machine for sterile ampoules and vials has a capacity of 1.5 million per annum.