SINGAPORE: iX Biopharma Ltd announced that its wholly-owned subsidiary, iX Syrinx has obtained the Good Manufacturing Practice (GMP) licence issued by the Therapeutic Goods Administration (TGA) of Australia for its testing laboratory located within its facility in Victoria, Australia.
As part of the Group’s GMP processes, every batch of raw material and finished product is rigorously tested to ensure compliance with the highest pharmaceutical quality standards prior to manufacture and market release, respectively.
The newly secured GMP licence permits the Group to conduct chemical and analytical laboratory testing for its commercial and developmental products in-house. This includes raw material testing, stability testing and finished product testing which are currently contracted to external third-party laboratories.
With the new licence, the Group will now be able to increase its speed-to-market as the testing and quality control process will no longer be dependent on the schedule of third-party testing laboratories. Further, in-house product testing also allows for potential cost savings.
Ms Eva Tan, Director, Corporate and Commercial Strategy of iX Biopharma said: “We are very pleased to have secured the GMP testing licence. We are now able to shift our laboratory testing operations in-house and potentially save on testing costs. In addition, we gain valuable control over the timing of release of our various pharmaceutical and nutraceutical products, allowing us to achieve better speed-to-market and respond with greater agility to meet our store requirements. These capabilities also complement our fully integrated business model which includes drug development to manufacturing and supply.”
The Group completed the sale of its laboratory testing business under Chemical Analysis Pty Ltd, which included a GMP testing licence, for A$12.5 million on 15 March 2019.
iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in Australia.
The Group is focused on the development and commercialisation of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.
The Group’s nutraceuticals division, Entity Health Limited, is engaged in the development and commercialisation of nutraceutical products that address specific conditions and improve quality of life.