MXC secures interim GMP certification for European facility
Hey! Looks like you have stumbled on the section of our website where we have archived articles from our old business model.
In 2019 the original founding team returned to run Next Investors, we changed our business model to only write about stocks we carefully research and are invested in for the long term.
The below articles were written under our previous business model. We have kept these articles online here for your reference.
Our new mission is to build a high performing ASX micro cap investment portfolio and share our research, analysis and investment strategy with our readers.
Click Here to View Latest Articles
MGC Pharmaceuticals (ASX:MXC) announced today that it has attained interim Good Manufacturing Practice (GMP) for its recently completed European medicinal cannabis production facility.
The interim certification is one of the final steps towards full GMP certification, with the latter allowing MXC to distribute its CannEpilTM product as well as other pharmaceutical-grade medicinal cannabis products.
The interim certification will pave the way for MXC to commence production of its first batch of CannePilTM. Upon completion of the first batch, the product will undergo validation of manufacturing and rigorous analysis before being approved for wider production.
CanneEpilTM is MXC’s first medicinal cannabis offering, which targets drug resistant epilepsy, also known as refractory epilepsy. Refractory epilepsy affects 30 per cent of the estimated 240,000 people diagnosed with epilepsy in Australia annually.
The company has partnered with Australian pharmaceutical distributor, HL Pharma Pty Ltd, to bring CannePilTM to the Australian market. Under the agreement, HL Pharma is responsible for ensuring Therapeutic Goods Administration (TGA) and Office of Drug Control approval to import and supply the products in Australia.
It’s worth noting here that this is an early stage play and investors should seek professional financial advice if considering this company for their portfolio.
A step closer to revenues
Upon Australian regulatory approval, CannEpilTM is projected to generate approximately A$1 million per annum in its first full year of distribution. Projected revenue is modelled on less than 100 current patients registered through MXC’s relationship with Epilepsy Action Australia.
The company also indicated that full GMP certification for its extraction facility remains on schedule, with the expected certification to place MXC in an advantageous position to capitalise on key markets in Europe, North America and Australasia.
Co-founder and CEO of MXC, Roby Zomer, commented on the promising update.
“MGC has a vision and defined strategy of becoming a leading pharmaceutical-grade medicinal cannabis company and the receipt of GMP certification for our European manufacturing facility is a key milestone in this journey.
“Once we receive full certification, we will be positioned to rapidly progress our operations in Europe with a core focus on medical research and development of the company’s pharmaceutical products pipeline,” Zomer said.
General Information Only
S3 Consortium Pty Ltd (S3, ‘we’, ‘us’, ‘our’) (CAR No. 433913) is a corporate authorised representative of LeMessurier Securities Pty Ltd (AFSL No. 296877). The information contained in this article is general information and is for informational purposes only. Any advice is general advice only. Any advice contained in this article does not constitute personal advice and S3 has not taken into consideration your personal objectives, financial situation or needs. Please seek your own independent professional advice before making any financial investment decision. Those persons acting upon information contained in this article do so entirely at their own risk.
Conflicts of Interest Notice
S3 and its associated entities may hold investments in companies featured in its articles, including through being paid in the securities of the companies we provide commentary on. We disclose the securities held in relation to a particular company that we provide commentary on. Refer to our Disclosure Policy for information on our self-imposed trading blackouts, hold conditions and de-risking (sell conditions) which seek to mitigate against any potential conflicts of interest.
Publication Notice and Disclaimer
The information contained in this article is current as at the publication date. At the time of publishing, the information contained in this article is based on sources which are available in the public domain that we consider to be reliable, and our own analysis of those sources. The views of the author may not reflect the views of the AFSL holder. Any decision by you to purchase securities in the companies featured in this article should be done so after you have sought your own independent professional advice regarding this information and made your own inquiries as to the validity of any information in this article.
Any forward-looking statements contained in this article are not guarantees or predictions of future performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results or performance of companies featured to differ materially from those expressed in the statements contained in this article. S3 cannot and does not give any assurance that the results or performance expressed or implied by any forward-looking statements contained in this article will actually occur and readers are cautioned not to put undue reliance on forward-looking statements.
This article may include references to our past investing performance. Past performance is not a reliable indicator of our future investing performance.