Our facilities for drug substances, regulatory starting materials and intermediates manufacturing are equipped with twenty-four hastelloy C22, stainless steel SS316L and glass lined reactors. With a total reactor capacity of 120,750L, we have an annual production capacity of up to 50 metric tons or more. The crystallization room, finishing and packaging areas are classified at ISO 8/Grade D (Class 100,000).
Pilot Scale (30 – 1,000L)
Product | Hastelloy C22 | Stainless steel SS316L | Glass lined |
---|---|---|---|
Drug substance/ RSM | Reactor 1,000L Tray vacuum dryer |
Reactor 250L | |
Pharmaceutical intermediates |
Reactor 300L Tray vacuum dryers |
Reactor 30 – 1000L |
Crystallization Room (2,000 ~ 2,500L)
Product | Hastelloy C22 | Stainless steel SS316L | Glass lined |
---|---|---|---|
Drug substance/ RSM | Crystallizer 2,000L Helix dryers |
Crystallizer 2,500L |
Commercial Scale (2,000 – 10,000L)
Product | Hastelloy C22 | Stainless steel SS316L | Glass lined |
---|---|---|---|
Drug substance/ RSM | Reactor 2,000 – 10,000L Inverting filter centrifuge Vertical bottom discharge centrifuge |
Reactor 5,000 – 10,000L | Reactor 2,500 – 10,000L |
Pharmaceutical intermediates |
Reactor 5,000 ~ 10,000L Vertical bottom discharge centrifuge (PTFE coating) Top discharge centrifuge Short-path & thin film distillation Tray vacuum dryer |
Reactor 3,500 – 8,000L |
Delivering safe drug substance with high and consistent quality requires unwavering commitment from the corporate management and across all departments such as supply chain management, manufacturing, regulatory compliance and quality assurance. The quality control department plays a critical role in providing reliable and trustworthy test data to support the decision of releasing only the products that meet the highest standards. The equipment, analytical instruments and analysis software in our quality control laboratories are installed, qualified and validated to ensure highest data quality and integrity. Some characterization testing such as differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), X-ray crystallography (XRD), nuclear magnetic resonance spectroscopy (H NMR, C NMR) and particle size distribution analysis (PSD) are performed through collaboration with local universities and testing institutes.
Analytical instruments
Physicochemical analysis
Chambers and Ovens
We are committed to delivering the highest quality in every batch of materials, controlling from incoming materials, manufacturing operations, in-process control, final product release to stability monitoring.