The Gurugram facility is a dedicated cephalosporin API and advanced intermediate manufacturing site, organised across three independent production modules. It manufactures twelve oral cephalosporin APIs and holds WHO-GMP certification, ISO 9001:2015, and COFEPRIS approval for the Mexican market.
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Built for Sterile API Manufacturing
Cephalosporin APIs
12
Regulatory Approvals
04
Capabilities
Three-Module API Production
The site runs three independent production modules, each equipped for end-to-end synthesis from advanced intermediate to finished API.
Drying & Particle Processing
A full range of drying technologies supports the variety of cephalosporin chemistries manufactured on-site.
Spray dryer, rotary cone vacuum dryer, and fluid bed dryer across all modules
Multimill, sifter, microniser, blender, and compactor for particle control
On-site nitrogen generation at 99.5% purity
HVAC & Containment
Clean room environments are maintained across all production areas, with separate controls for wet and dry manufacturing zones.
ISO Class 8 clean rooms throughout
Wet section runs once-through air; dry section runs at 20 air changes per hour
Temperature below 30°C and RH below 55% across all classified zones
Quality Control
All testing is handled in-house across six dedicated labs.
HPLC, GC with headspace, FTIR, UV-Vis, and Malvern particle size analysis
Six stability chambers covering all ICH conditions
Approvals & Certifications
India / WHO scheme
India / WHO scheme
21 CFR Part 210/211 United States
EU & UK
EU & UK
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EU & UK
EU & UK
India / WHO scheme
India / WHO scheme
21 CFR Part 210/211 United States
EU & UK
EU & UK
EU & UK
EU & UK
