Certification

„Antibiotic-Razgrad” AD is a holder of:

Wholesale distribution authorization with medicinal products for human use, issued by Bulgarian Drug Agency at the Ministry of Health, Bulgaria;

Wholesale distribution authorization with medical devices, issued by Bulgarian Drug Agency at the Ministry of Health, Bulgaria.

„Balkanpharma-Razgrad” AD is a holder of:

Manufacturing/Importation Authorization of medicinal products, issued by Bulgarian Drug Agency at the Ministry of Health;
Registration of Manufacturer, Importer or Distributor of Active Substances, issued by Bulgarian Drug Agency at the Ministry of Health;
Manufacturing Authorization for veterinary products, issued by the National Veterinary Service of Bulgaria at the Ministry of Agriculture and Food of the Republic of Bulgaria;
Certificate of GMP Compliance, issued by Bulgarian Drug Agency at the Ministry of Health;
Certificate of GMP compliance, issued by Bulgarian Food safety Agency at the Ministry of Agriculture and Food;
Certificates of GMP compliance, issued by State Service of Ukraine on Medicines and Drugs Control for production and quality control of:

- capsules and tablets;
- eye drops and eye ointments.

Certificates of GMP compliance, issued by Ministry of industry and trade of the Russian Federation for production and quality control of:

- capsules and tablets;
- creams and ointments for topical use.

Certificates for compliance, issued by SGS:

- of the management system with the requirements of ISO 9001:2015 (For Design and production of sterile and non sterile medicinal and non medicinal products);
- of the management system with the requirements of EN ISO 13485:2016 design and production of sterile eye drops solution;
- of the management system with the requirements of Directive 93/42/ЕЕС on Medical devices Annex II,(excluding section 4) for non-medicinal, sterile lubricating eye drops for treatment of dry eyes and use in combination with contact lenses.