KENDY PHARMA • BOZHURISHTE
International trust standards
These certificates and registrations are issued to KENDY Ltd. and apply to the production of Lactoflor finished products.
ISO 9001:2015
International quality management standard. It ensures consistency and improvement across all processes.
Good Manufacturing Practices
Good Manufacturing Practice - a European standard for pharmaceutical production, safety, and hygiene.
U.S. FDA
Registration with the U.S. Food and Drug Administration. Access to the U.S. market.
EFSA QPS
Qualified Presumption of Safety - European safety recognition for all our probiotic strains.
Production registration (BFSA)
Registration Certificate No. 260 of the food supplement production facility, issued by the Bulgarian Food Safety Agency.
LACTINA PRODUCTION FACILITY • BANKYA
Certificates for strain production
These documents are issued to "Lactina" Ltd., Bankya, and refer to the production of starter cultures and probiotic strains. The certificates for the finished products Lactoflor - GMP, FDA, and the BFSA registration - are issued to "KENDY" Ltd. and are shown above. Some of the documents below have expired and are shown only for production traceability - the current status is noted on each card.
FSSC 22000
Food safety management system. Scope: production of probiotics and starter cultures for the food industry.
Halal
Approval for the production site, laboratory equipment, and warehouses in Bankya.
Kosher
Issued by the Chief Rabbinate of Bulgaria for Lactina's starters and probiotics. The products are kosher dairy (Chalav Stam) and are not for Passover.
Organic entry
Confirmation that probiotic cultures can be used as an ingredient in organic production.