We have the expertise, capabilities and infrastructure to safely and securely manufacture controlled substance APIs.

Sterling’s first-class, fully licensed, controlled substance manufacturing facilities can handle potent materials.

We can manufacture a range of controlled drug substances for various therapeutic applications and have the security infrastructure in place to meet all regulatory demands.

Our unique capabilities, combined with our expertise in analytical testing, stability studies and cGMP manufacture, ensure we can scale controlled substance products from pre-clinical to any volume of commercial manufacturing.

Capabilities

  • Sterling UK is licenced by the Home Office to manufacture Schedule 2-5 (II-V)
  • Sterling US is licensed by the DEA to manufacture Schedule 2-4 (II-IV)