API Manufacturing

With a successful performance record of over 40 years, we manufacture and supply Active Pharmaceutical Ingredients (APIs) through our sites in North America, Europe, and Asia markets. Our API facilities are inspected and approved by global regulatory bodies, including the US FDA, Japan PMDA, and UK MHRA, and meet the cGMP compliance standards.

We are the preferred partner for big pharma and biotech companies across North America and Europe with the total reactor volume exceeding 500 KL (including pilot and multi-purpose plants). We have a record of accomplishment of over 30 Launches and are capable of executing extensive small molecule API requirements.

Specialized capabilities

  • Flexible Containment facility
  • cGMP multi-purpose pilot plants
  • Total reactor capacity of >500 KL
  • Multi-stage synthesis with continuous cost improvement
  • Micronization, filtration/drying, and continuous liner pack off capability
  • Capability to handle a range of reactions including:
    • High temperature de-carboxylation
    • Enzymatic
    • Cryogenic
    • Hydrogenation
    • Cyanation
    • Friedel-Crafts chemistry

Services Offered

We are involved in the manufacturing and supply of:

  • High Potent APIs (HPAPIs)
  • Key Starting Materials (KSMs)
  • Registered Starting Materials (RSMs)
  • Key GMP Intermediates
  • Commercial-scale APIs