Infrastructure

World-Class Facilities Built for Innovation, Quality, and Compliance

At Amoli CDMO, our infrastructure reflects over three decades of manufacturing excellence and our commitment to global standards in pharmaceutical development and production.

We have invested in state-of-the-art R&D centers, pilot plants, and cGMP-compliant manufacturing facilities designed to deliver end-to-end solutions — from process development to commercial-scale production.

Our facilities are built to meet the rigorous expectations of international regulatory authorities, ensuring safety, scalability, and quality across every molecule we manufacture.

Research & Development Centers

Our R&D facilities are the foundation of Amoli’s innovation ecosystem.

Equipped with advanced synthetic, analytical, and process engineering laboratories, they enable rapid route development, optimization, and validation.

Key R&D Capabilities:

• Dedicated Process Development, Analytical, and Scale-Up laboratories
• Advanced instrumentation including HPLC, UHPLC, GC, LC–MS, DSC, XRPD, KF, and NMR
• QbD and DoE software tools (Minitab, Design Expert) for data-driven optimization
• Process Engineering Lab with automation and PAT tools for real-time monitoring
• Experienced scientists skilled in API development, impurity profiling, and process intensification

Our R&D team works closely with partners to ensure seamless technology transfer from laboratory to plant, with a strong focus on scalability and regulatory readiness.

Pilot Plant Facilities

Amoli’s pilot-scale facilities serve as the bridge between R&D and commercial manufacturing.

Designed to replicate large-scale conditions, our pilot units are equipped with identically configured reactors, filtration systems, and utilities, ensuring reliable process reproducibility.

Pilot Plant Highlights:

• Glass-lined and stainless-steel reactors ranging from 10 L to 16 kL
• Controlled reaction environments (cryogenic to high-temperature operations)
• Filter dryers, centrifuges, and crystallizers
• Inline analytical and process safety monitoring
• Management of Change (MoC) and risk assessment systems for smooth tech transfer
• Capability to handle complex chemistries, including hazardous and multi-step reactions

The pilot plant provides the flexibility needed for scale-up trials, process validation batches, and client demonstration runs, ensuring a confident transition to commercial production.

Commercial Manufacturing Units

Our cGMP manufacturing sites are designed to produce APIs and advanced intermediates at commercial scale while maintaining the highest standards of safety, quality, and environmental responsibility.

Manufacturing Infrastructure Includes:

• Glass-lined and stainless-steel reactors (10 L – 16kL capacity)
• Multiple dedicated production blocks for chemical synthesis and purification
• Centrifuges, dryers, and crystallization systems for solid processing
• Sophisticated utility systems — nitrogen, vacuum, cryogenic, and high-pressure operations
• Segregated areas for potent and sensitive compounds
• Controlled HVAC systems meeting international cleanroom classifications

Each facility is supported by utility monitoring, automation, and electronic batch recording systems, ensuring precision and traceability throughout every stage of production.