Late phase & commercial manufacturing
cGMP manufacturing services for API and intermediates in late-phase and commercial
We provide full-fledged cGMP manufacturing services for API and intermediates in late phase and commercial.
Why choose Sai?
- FDA and PMDA-certified facility
- 80% of capacity is less than 5 years old
- Hydrogenation, Cryogenics, Lyophilization, Commercial chromatography capabilities
- PLC automated manufacturing blocks
- Online Quality management system
- Approved by several big pharma customers from HSE and Quality perspectives
- Zero liquid discharge
Superior quality management
Our quality management system operates online through a system that has received appreciation from many clients and regulatory bodies. We provide regulatory services to support DMF and CMC section packages for NDA filings. An Operational Excellence team works alongside the various departments to bring about continual improvement.
How does it work?
Sai Life Sciences provides GMP Active Pharmaceutical Ingredients and intermediates for late clinical phase and commercial New Chemical Entities for US, European and Japanese innovators. Our flagship manufacturing facility in Bidar, India has a 400 KL capacity and has successfully passed US FDA and Japanese PMDA inspections. We utilize hydrogenators ranging from 0.5 KL to 4 KL that can operate up to 50 bar, cryogenic reactors with an operating range down to -80 °C, air jet mills, a 300-L lyophilization suite, and class 100,000 clean rooms providing enhanced capabilities for a wide range of processes.
Our production blocks have been designed for flexibility across multi-purpose reactor trains. The two newest production blocks account for ~80% of the capacity outfitted with PLC automation systems to perform pre-programmed automation sequences, ensuring process repeatability. We operate at containment levels of 10 mcg /m3.