TGA Accepts Initial Registration Dossier for Evaluation

• TGA accepts initial registration dossier for evaluation
• Marks significant milestone in pathway to product commercialisation
• First product of 7-medicine portfolio to enter TGA registration process

Algorae Pharmaceuticals Ltd (ASX: 1AI) has announced that the Therapeutic Goods Administration (TGA) has accepted the company's initial registration dossier for evaluation. This acceptance confirms that the application has met the TGA's preliminary assessment requirements and will now progress through the formal evaluation process. This marks a significant execution milestone in Algorae's pathway to product commercialisation in the Australian market. The company notes that application acceptance represents an early step in the regulatory review process and does not indicate the outcome of the evaluation. Algorae's commercial division, AlgoraeRx, has executed Licence and Supply Agreements with Sakar Healthcare Limited and Cadila Pharmaceuticals Limited, covering an initial portfolio of seven generic medicines for the Australian and New Zealand markets. The product subject to this application submission is the first of those products to enter the TGA registration process. TGA registration, if achieved, will enable commercial supply under the Algorae Pharmaceuticals brand. This is the first of multiple planned TGA registration submissions, and the company is progressing further applications across its medicine portfolio alongside a range of commercial and licensing initiatives.