SUDA Pharmaceuticals Ltd (ASX:SUD) has received Therapeutics Goods Administration (TGA) approval for registration of its lead product ZolpiMist™ for the treatment of short-term insomnia in adults.
TGA approval enables ZolpiMistTM to be sold in Australia, enables a more competitive supply price and supports corresponding submissions in additional territories.
Following a Marketing Authorisation Application (MAA) submission to the TGA for ZolpiMist™ in April 2019, the company made a strategic decision to register a supplemental active pharmaceutical ingredient supplier and final product manufacturer.
This required an amendment to the TGA submission.
TGA approval includes the supplemental API supplier and final product manufacturer, which allows SUDA to supply the product at a more competitive supply price and potentially allows the company to target additional territories.
“Looking forward” to commercial sales
Chief executive officer and managing director Dr Michael Baker said: “The TGA submission was a combined effort by SUDA’s technical team as well as our regulatory consultant, Pharma To Market.
“Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist™.
“We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future.”
Benefits of TGA approval
The benefits of TGA approval are:
- ZolpiMist™ will be included on the Australian Register of Therapeutic Goods and can be commercialised and supplied within Australia;
- Demonstrates SUDA’s compliance with Good Manufacturing Practice and an ability to obtain regulatory approvals for its products; and
- It will assist current partners, TEVA, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in submissions in their respective territories with the amended API supplier and manufacturer.