• +251- 911- 67-08-20 | +251- 924- 91-04-84
  • danielwaktole69@gmail.com | bhavinmehta@kilitch.com
  • Oromia, Ethiopia.
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Partnering with

A Pioneering Cephalosporin Manufacturing Facility

Kilitch Estro Biotech PLC (KEB) partners with organizations seeking a reliable, compliant, and audit-ready pharmaceutical manufacturing facility in Ethiopia, East Africa. Our partnerships are grounded on strong regulatory credibility, with facilities designed to meet the rigorous requirements of stringent regulatory authorities such as the EU and the US FDA.

Current Installed Capacity

CEPHALOSPORIN
INJECTIONS

Lines : VIALS

0 +
Capacity 8hr per shift
0 +
Anual Capacity 3 shift

CEPHALOSPORIN
TABLETS

Lines :TABLETS

0 +
Capacity 8hr per shift
0 +
Anual Capacity 3 shift

Cephalosporin Dry Powder
for Suspension

Lines : Bottles

0 +
Capacity 8hr per shift
0 +
Anual Capacity 3 shift

Cephalosporin
Capsule

Lines : Capsules

0 +
Capacity 8hr per shift
0 +
Anual Capacity 3 shift

Antiseptic and Disinfectant


Lines : Bottles

0 +
Capacity 8hr per shift
0 +
Anual Capacity 3 shift

Why Partner with KEB

EFDA cGMP–Approved Manufacturing Facility

KEB operates a dedicated sterile and non-sterile cephalosporin manufacturing facility that has been inspected and approved by the Ethiopian Food and Drug Authority (EFDA). The facility is designed and operated in accordance with EFDA cGMP requirements and aligned with international regulatory expectations, providing confidence to partners operating in regulated markets. 

Proven Regulatory Exposure

KEB’s manufacturing facility has undergone multiple regulatory inspections and partner audits, demonstrating inspection readiness and compliance maturity. These include:

EFDA GMP inspections

EU cGMP facility audit (QP audit – February 2023)
WHO-PQ audit support (capacity assessment – June 2023)
Viatris audit for contract manufacturing (September 2024)
KEB is actively participating in and planning further engagement with regional and international regulatory initiatives, including ZAZIBONA, EAC, AUDA-NEPAD, and PIC/S-aligned inspections, as well as with national regulatory authorities from Kenya, Nigeria, Tanzania, and others. 

Independent Quality System

KEB maintains a fully independent Quality Unit, organizationally separate from production and commercial functions, with full authority to approve or reject raw materials, in-process materials, packaging materials, and finished products. This structure is fully aligned with EFDA cGMP and international regulatory expectations.

Utilities and Environmental Control

The facility operates validated utility and environmental control systems to ensure personnel safety, product integrity, and environmental protection. These include validated HVAC systems with HEPA filtration, differential pressure control between areas, purified water and WFI systems with loop circulation, and controlled microbiological and chemical monitoring programs.

Partnership Engagement

Kilitch Estro Biotech PLC welcomes partnerships with organizations that share our commitment to quality, regulatory compliance, and improving access to safe and effective medicines. We are open to collaborative engagements that align with our mission and values, and that contribute to sustainable pharmaceutical manufacturing and supply.

Partnership opportunities may include contract manufacturing, technology transfer, regional and international market supply, institutional and tender-based procurement, and regulated export programs. All partnerships are conducted within formal quality agreements, robust regulatory compliance frameworks, and clearly defined governance structures to ensure transparency, accountability, and long-term success.

Why Partner with KEB