Sterile Injectable Manufacturing
A new sterile manufacturing facility dedicated to freeze-dried cephalosporin injectables, including a dedicated suite for cefiderocol. Built to US FDA, EU, WHO, and Indian standards.
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Built for Sterile API Manufacturing
Built for Sterile API Manufacturing
Grade A aseptic environment
Dedicated cephalosporin facility
Capabilities
Sterile Injectables
The facility is built around freeze-dried (lyophilized) injectable vials. The site is dedicated to cephalosporins and kept fully separate from any other product family.
Freeze-dried vials, 10 ml format
30,000 vials per batch
1 million vials per year at start-up, expandable to 3 million
Dedicated suite for cefiderocol manufacturing
Aseptic Filling
Filling happens inside a barrier system that keeps the operator separated from the product, in the cleanest air grade used in pharmaceutical manufacturing.
Grade A filling environment within a Grade B background
Restricted Access Barrier Systems on the fill line
Steam, dry-heat, and vapour-phase sterilisation on-site
Final filtration before fill
Cleanroom Infrastructure
The whole sterile area sits inside a tightly controlled environment, with temperature, humidity, and air pressure managed at every step.
19 air handling units with high-grade HEPA filtration
Temperature held below 24 °C; humidity dropped to 15% during filling
21 personnel airlocks, 5 material airlocks, and 13 pass-boxes
Cleanroom-grade walls, ceilings, doors, and seamless epoxy floors
Water & Utilities
Pharmaceutical water and clean utilities are produced on-site to international standards.
Water for Injection: 1,550 litres per hour, stored hot and continuously circulated
Pure steam: 1,500 kg per hour
Nitrogen at 99.999% purity, generated in-house
Oil-free compressed air
On-site effluent treatment at 100,000 litres per day
