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Chemical Development

Sundia has been providing process development and scale up production service since 2004. Our services include the laboratory works such as process research and small scale synthesis of APIs which are used for preclinical and pre-formulation studies. Our services further extend to relatively large scale kilo lab synthesis as our client's program moves to phase I clinical studies. At this stage, we can help client identify the synthesis route and optimize the process, followed by non-GMP and/or GMP-required synthesis of intermediates and APIs. As your clinical program moves forward, we can make more intermediates and APIs to support your Phase II and III clinical trials and commercialization needs in our production site.

We also provide service for our clients to develop better and/or non-patent infringing processes for many drugs which are already in the market and provide CMO services for our clients either under non-GMP or GMP conditions. 

Chiral Technologies
• Chemical resolution
• Enzymatic resolution
• Asymmetric synthesis
• Separation in large scale

Process Chemistry and Scale up
• Route discovery and definition
• Process improvement and optimization
• Robustness/process limits testing
• Salt and polymorph screening/selection
• Process scale-up for demonstration
• Technology transfer to commercial scale
• Preparation of pharmaceutical intermediates
• Preparation of active pharmaceutical ingredi¬ents (APIs) under cGMP controls
• Multi-gram to multi-ton manufacture

Sundia Chemical Service Facilities
• Five (5) modern, well-equipped process chemistry laboratories with ninety (90) hoods and five (5) walk-in hoods
• One (1) non-GMP kilo laboratory with ten (10) walk-in hoods
Ten (10) reactors from 25 liters to 100 liters
• One (1) GMP kilo laboratory with eleven (11) walk-in hoods
Twelve (12) reactors from 30 liters to 100 liters operated in compliance with US FDA cGMP regulations,
• Multipurpose GMP pilot plants
Forty two (42) reactors from 100 liter to 5,000 liter. GLS/SS materials of construction standard temperature range: -80° C to +250°C
Standard pressure range: FV to 450 psig
Isolation/finishing rooms for drying, milling, blending, and packaging operations
Complete support equipment operated in compliance with US FDA cGMP regulations
• Analytical laboratories incorporating a broad range of qualified analytical instrumentation

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