BIOTON’s assembling site in Macierzysz close to Warsaw is one of the most current biotechnological offices on the planet. This is the place insulin is created – both the dynamic pharmaceutical fixing and the completed restorative structure. BIOTON produces the most excellent insulin on a business scale, guaranteeing sheltered and powerful diabetes treatment for patients.
BIOTON has two assembling offices: Production Facility No. 1 where completed therapeutic structures are made and our Biotechnology Facility where we produce the dynamic pharmaceutical fixing.
The key objective and need of our action is to guarantee our patients’ wellbeing by assembling the best dynamic pharmaceutical fixing (recombinant human insulin), just as compelling, protected and tough restorative items. Every one of our items are produced in consistence with legitimate guidelines and Good Manufacturing Practice norms. We hold consistently restored GMP endorsements gave by the Chief Pharmaceutical Inspector just as unfamiliar bodies. The affirmation covers all our creation lines, QC procedures and stockrooms. Our items are fabricated and controlled as per particulars and documentation that are the reason for giving showcasing approvals for restorative items. We have a quality confirmation framework set up and persistently flawless it, therefore guaranteeing the highest caliber of the items we make.
With a plan to guarantee the quality and wellbeing of our clinical gadgets, we have actualized a quality administration framework consistent with the EN-ISO 13485: 2016 norm, affirmed by an endorsement gave by TUV Rheinland. The declaration is affirmed and recharged during yearly reviews.
Quality validation for gensulin R 100 IU ml products (.pdf)
Quality validation for gensulin N 100 IU ml products (.pdf)
Obligation regarding the earth is a need for BIOTON. Our exercises consent to Polish law, and in our creation, examination and ventures we generally consider the natural perspective. Bioton’s specialists effectively take an interest in acing their skills and help out scholastic places on ecological activities.
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