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ACRUX LIMITED — Audit Report / Information 2020
Apr 15, 2020
64293_rns_2020-04-15_a7eb9e70-113e-4652-a793-5067c3816ff1.pdf
Audit Report / Information
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16 April 2020
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Acrux TGA audit outcome
Melbourne, Australia; 16 April 2020: Acrux Limited (ASX:ACR, “ Acrux ” or the “ Company ”) is pleased to confirm the outcome of a recent Australian Therapeutic Goods Administration (TGA) Good Manufacturing Practice (GMP) audit of the Company’s facilities in West Melbourne.
Acrux confirms that there were no Critical Deficiencies or Major Deficiencies noted by the TGA. As is common in these types of audits a small number of Other Deficiencies were noted and Acrux will be able to outline to the TGA its plan to close out these deficiencies within the requested response timelines. These deficiencies are not considered by Acrux to be material in nature.
TGA licence holders are regularly inspected by the TGA to ensure compliance with GMP standards.
Acrux Product Development and Technical Affairs Director, Felicia Colagrande said: “ I am extremely pleased with the result of the audit of the Acrux facility by the TGA. It is a testament to the hard work of all Acrux staff. The successful inspection of the Acrux facility provides Acrux with the ability to manufacture Phase 2 and Phase 3 clinical trial drug product .”
Authorised by the Board of Acrux Limited.
For more information, please contact:
General enquiries
Michael Kotsanis Acrux Limited CEO & Managing Director
P: + 61 3 8379 0100 E: [email protected]
About Acrux
Acrux (ASX: ACR) is a pharmaceutical company dedicated to developing and commercialising topical pharmaceuticals. Incorporated in 1998 and using in house facilities and capabilities, Acrux has successfully developed and commercialised through licensees a number of topically applied pharmaceutical products in the US and Europe. Acrux is developing of a range of generic products for the US market by leveraging its on-site laboratories, GMP manufacturing suite, clinical and commercial experience to bring affordable products to market. Acrux encourages collaboration and is well positioned to discuss partnering and product development.
For further information on Acrux, visit www.acrux.com.au