Commercial Manufacturing

RSM, API, HPAPI, NCE & Novel Advanced Intermediates

Syngene has capabilities for cGMP and chemical manufacturing from benchtop volume to commercial scale. Depending on the end application, manufacturing is done at an appropriate facility in Syngene. We have extensive experience in manufacturing batches for pre-clinical, clinical, and commercial applications. Our commitment to safety and regulatory compliance has helped us become the trusted partner for several global customers.

Here are some of the reasons why our customers choose us:

  • Manufacturing of Regulatory Starting Materials (RSM), 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 with 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

  • Broad range of batch sizes between < 100 kgs to 400 kgs output / batch

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