Bionika Pharmaceuticals meets the requirements of internationally recognized quality standards that apply to the production and quality of pharmaceuticals. This is confirmed by regular inspections of domestic and international authorities, as well as checks by our customers and partners.

In 2012, Bioniкa Pharmaceuticals received a Certificate of GMP Compliance of a Manufacturer from the Ministry of Health for packaging and quality control of solid, liquid, semi-solid and gaseous dosage forms. Same year, our company also received a Decision on Registration in the Register of Food Facilities and Operators from the Food and Veterinary Agency for the production of food supplements.

Certificate of GMP compliance

Certificate of GMP compliance

Food supplement manufacturing Licence

In 2015, Bionika Pharmaceuticals launched its new section for the production of solid dosage forms: suppositories and pessaries, semi-solid and liquid dosage forms, built in compliance with European and international GMP requirements and in March obtained the Decision on Reistration for production of cosmetic products, issued by the Ministry of Health. In 2019, the production of solid dosage forms: suppositories and pessaries, semi-solid and liquid dosage forms, packaging and quality control was verified with the EU Certificate of GMP Compliance of a Manufacturer from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia. Also in May 2017, Bionika Pharmacutical was awarded with а certificate of appreciation for a long and successful cooperation from the Pharmacеutical Chamber of the Republic of North Macedoniа. Our quality management system follows the principles and norms of Good Manufacturing Practice, as well as other applicable international standards and is implemented in our company with the aim of creating, maintaining and continually improving the quality of our products.