Syngene has capabilities for current Good Manufacturing Practices (cGMP) manufacturing from benchtop volume to commercial scale. Since 2015, we have generated around 150 metric tons of materials for various projects. We offer end-to-end solutions from GLP-Tox batches to clinical supplies, scale up, launch and commercial manufacturing.

Key features of our small molecules facilities:

• Manufacturing of Regulatory starting materials (RSMs), APIs, HPAPI, NCEs & Novel advanced intermediates

• Broad range of reactors (stainless steel, glass lined, hastelloy) and capabilities to handle varied chemistries (asymmetry catalysis, halogenation)

• High potency expertise (cytotoxic, cytostatic compounds up to 0.1 μg/m³ – 8h OEL)

• Hydrogenator for highly acidic/basic reactions with capacity up to 4 KL volume and 20 bar rating

• High vacuum (< 10 Torr) & high temperature (140°C) distillations

• 12 KL cryogenic reactor operating within a temperature range of -90°C to 140°C

• PMDA (commercial) and USFDA (RSM) approved manufacturing facilities