This site license is subsequent to the drug establishment license received by the same manufacturing facility. The issuance of this license permits the Sydney facility to manufacture natural health products.
The facility is also anticipating the imminent issuance of its precursor license under the Controlled Drugs and Substances Act which will allow the site to broaden the portfolio of controlled substances that it currently produces.
The 46,400 sq ft Sydney facility includes pilot laboratories for formulation development, rooms with various capabilities such as high shear mixing, container blending and equipment for modified release technology. The facility provides formulation development and testing services to manufacture and package products in solid and liquid dosage forms.
The Sydney site also includes offices for PharmEng’s pharmaceutical consulting division. Keata’s long-term goal is to develop capabilities in other dosage forms, such as suppositories, topicals and injectables.