ANI has the capability of manufacturing potent products in a contained and safe manner. Our state-of-the-art facility is designed to meet or exceed requirements for operator safety. EPA requirements are monitored with electronic back-up systems in place.
Our facility is built to support Category 3a compounds. We review each active pharmaceutical ingredient individually to ensure that the robust controls we have in place are a match for each incoming product to be manufactured safely at the facility.
DEA Controlled Substances
In addition, ANI has added controlled substance handling capability to our portfolio. In 2016 a new cage and vault were approved by DEA for working with up to Class II controlled substances. In Canada, a level 6 vault is in place to handle up to controlled substance street value of $6,000,000 as per Health Canada guidelines.