Mission
Acrux is a Pharmaceutical Company Dedicated to Developing and Commercialising Generic Topical Prescription Pharmaceuticals.
About Acrux
Acrux is a specialty pharma company with a successful track record of developing and commercialising a pipeline of topically applied pharmaceutical products. Drawing on 25 years of experience, Acrux has successfully marketed through licensees a number of products worldwide with emphasis on the United States. Acrux is formulating and developing a range of topical generic products by leveraging its highly skilled workforce, on-site laboratories, GMP manufacturing suite, technical, clinical and commercial experience to bring affordable products to market. Acrux encourages collaboration and is well positioned to discuss commercial partnering and product development opportunities.
Facilities and capabilities
With onsite laboratories and a GMP manufacturing facility, Acrux has the capabilities and facilities for early development through to clinical trial manufacture. We hold a TGA clinical trial manufacturing licence.
Acrux employs Quality by Design (QbD) principles in its product development.QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and controls, based on sound science and quality risk management.
Acrux employs highly skilled formulation scientists and analytical chemists to develop topical and transdermal products from inception where the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) are established and defined through to regulatory dossier submission. This pharmaceutical development process includes the following:
- Analytical tools and techniques to reverse engineer and characterise the composition of reference products
- Analytical method development and validation
- Intellectual Property analysis
- Formulation development and small scale manufacture
- In-vitro testing of formulations including In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT) on human skin
- Stability testing of prototype formulations
- Container closure selection and development
- CMC studies and reports for regulatory submissions
- Technical Transfer and project management of contract manufacturers
Shareholders
Acrux Limited is a listed entity on the ASX and is a Pooled Development Fund, registered under the Pooled Development Fund Act 1992.
Under the Pooled Development Fund Act 1992, shareholders are entitled to concessionary tax treatment in Australia for income and capital gains derived in connection with their shareholding. Gains realised on the disposal of shares will not be included in an investor’s assessable income in Australia. An investor will not be entitled to any deduction or capital loss on the sale of shares. Unfranked dividends received by an Australian resident will be exempt from tax. Franked dividends will also be exempt from tax unless the shareholder elects to be taxed.
An Australian corporate tax entity may credit its franking account (with franking credits attaching to a franked dividend), regardless of whether it has elected to treat the dividend as exempt or assessable income. Dividends paid to non-residents will not be subject to withholding tax. A shareholder or prospective shareholder should obtain their own tax advice rather than relying on this summary.