Australian OINDP specialist CDMO Ab Initio announced that the Therapeutic Goods administration of Australia (TGA) has granted the company a license to manufacture finished inhalation products and nasal sprays, in addition to other dosage forms. Ab Initio says that the license allows it to offer services including manufacturing of finished products for clinical trials, repackaging, trial blinding, quality control and release for supply.
According to the company, Ab Initio is now the only contract manufacturing organization in Australia able to develop MDIs, DPIs, and nasal sprays “from bench through to GMP manufacturing, QC and release.” The company also
Ab Initio CEO and Head of Production Paul Young commented, “Ab Initio works in partnership with numerous start-ups and SMEs who have a molecule but no product strategy or formulation. Ab Initio helps clients develop these innovations into finished products ready for the clinic. With Ab Initio’s GMP manufacturing plant now being fully operational, we now have the capacity to take innovations from our R&D facility into the clinic.”
Chief Operating Officer and Head of Quality William Glover added, “Ab Initio’s TGA License is a significant milestone in the development of our company. With Australia being a hub of innovation in the therapeutic arena, coupled with its location as a ‘go to’ place for clinical trials, having an onshore facility that can manufacture finished product for first in human and later trials in a regulated environment will significantly enhance Australia’s capability.”
Read the Ab Initio Pharma press release.
