EFDA
Approved
cGMP
Certified
Commitment to Excellence
Trusted by Regulators Driven by Safety
At Kilitch Estro Biotech PLC, quality is our foundation. We operate one of East Africa’s first EFDA-approved cGMP facilities, specializing in sterile and non-sterile cephalosporin manufacturing. Every step, from raw material intake to finished product release, is governed by rigorous quality systems, international standards, and a culture of continuous improvement.
How It Works
Our Quality Promise
EFDA cGMP Certified
Regularly inspected and compliant.
WHO-PQ Submitted
Aligned with global quality benchmarks.
International Audits
Successfully audited by EU, Viatris, and more.
Advanced Laboratory Setup
Equipped for HPLC, GC, Microbiology, and Stability Testing.
Robust Quality Management System
Integrated oversight at every production stage.
Why Choose
KEB for Quality
Pioneering Manufacturing
First in East Africa for aseptic cephalosporin manufacturing.
End-to-End Oversight
Seamless integration from QA to QC to Pharmacovigilance.
Transparent & Audit-Ready
Always open to regulatory and partner inspections.
Patient-Centric Safety
Patient safety is at our core, supported by a dedicated adverse event reporting system.