Production of Active Pharmaceutical Ingredients (API)
Biotika name is closely linked to the fermentation of Active Pharmaceutical Ingredients. Historical milestones of Biotika are connected with biotechnological fermentation production of penicillin, which in some variation is preserved until today. Biotika is a manufacturer of phenoxymethylpenicillin in various forms, with its antibacterial activity it ranks among essential ingredients for the preparation of semisynthetic penicillins.
Biotika is important manufacturer of Polymyxin B Sulfate, produced by own original procedure.
Our APIs are distributed worldwide.
Contract Manufacturing of Active Pharmaceutical Ingredients (API)
Nowadays, Biotika is focused on fermentation production, and offer own fermentation capacity for contract manufacturing of Active Pharmaceutical Ingredients. Production on individual production lines is automatical and fermentation lines operate according to the principles of GMP.
Our bioreactors are universally equipped with a possibility of dosing of solutions of several substances during fermentation. We own bioreactors in the volume of 5 m3, 15 m3, 40 m3, 50 m3 and 150 m3 with a total capacity of more than 1400 m3.
Biotika is in the present partner for esteemed global companies from Germany, Switzerland, the USA and the Russian Federation.
Contract Manufacturing of final dosage formulations
Based on established conditions, Biotika offers possibility for contract manufacturing of final dosage formulations. Production area, processes and equipment are compliant with standards of European Community for Good Manufacturing Practice (cGMP ﴿ issued by The European Medicines Agency (EMA﴿.The production is carried out in the clean area grade A/B; D. Manufacturing areas, equipments and operations are regularly validated. We are regularly inspected by the upper state control authority – the State Institute for Drug Control (SIDC﴿ and audits performed by our partners – customer audits.