Overview

From our site in Longmont, CO, USA, we develop and manufacture small molecule drug substances and drug products with full analytical development and cGMP testing support.

Home to a team of more than 90 employees, the site is comprised of four cGMP drug substance production suites with capacity up to 200 L, as well as two non-GMP scale up laboratories. We also have a recently commissioned cGMP drug product complex with four manufacturing suites capable of providing powder in bottle, powder in capsule and tablet formulations as well as packaged and labelled drug products.

Our site is also equipped to handle potent compounds up to SafeBridge 3B for drug substances and 3A for drug products. The facility also has a research license for the handling of controlled substances.

In addition to this, we offer standalone analytical services to our clients. This includes method development, validation and cGMP/non-GMP testing. We are proud to offer a fully equipped Materials Characterization lab capable of providing testing of elemental impurities by ICP-MS, XRPD, particle size, DSC, TGA and TGA-GCMS.

Facility details

  • 4 cGMP API production suites (up to 200 L)
  • 4 cGMP DP production suites
  • 2 non-GMP kilo laboratory (up to 200 L)
  • Process chemistry development laboratories
  • Large R&D analytical development and QC laboratories
  • DP formulation development laboratories
  • FDA inspected