Our dedicated beta-lactam manufacturing site, producing both oral and sterile cephalosporin APIs. It is one of only three US FDA-approved sterile cephalosporin API sites in the world and holds active approvals across six major regulatory authorities.
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Built for Sterile API Manufacturing
Validated APIs
29
Independent Sterile Phases
04
Active Regulatory Approvals
06
Capabilities
Synthesis & Isolation
The site runs multiple independent production phases, each equipped for end-to-end API synthesis from reaction through to isolation and drying.
Glass-lined and stainless steel reactors across all phases
Dedicated isolation, drying, and blending equipment per phase
All product-contact surfaces SS316L
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Sterile Manufacturing
Four independent sterile phases, each operating as a self-contained environment with its own utilities, air handling, and access controls.
RABS on Phase-18 for the most critical sterile operations
LAF hoods at every critical interface
VHP generators for chamber and isolator sanitisation
Lyophilization
A dedicated lyophilization phase with two lyophilizers, supporting APIs that require freeze-drying as part of their manufacturing process.
Two lyophilizers with VHP-qualified chamber sanitisatio
Dedicated WFI and Pure Steam Generators per sterile phase
Quality Control
All testing is handled in-house across a fully equipped QC laboratory.
30+ HPLC systems and 15+ GC systems with headspace
Particle size analysis, sterility testing, and microbial identification
Walk-in stability chambers under internationally recognised conditions
Approvals & Certifications
(CDSCO / Tamil Nadu) India / WHO PQ
(CDSCO WC-0131) European Union
Chief Pharmaceutical Inspector (Poland)
United States
South Korea
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Japan
(CDSCO / Tamil Nadu) India / WHO PQ
(CDSCO WC-0131) European Union
Chief Pharmaceutical Inspector (Poland)
United States
South Korea
Japan
