PharmaCielo Provides Update on GMP Compliance Process
- Colombian and Mexican GMP certifications expected during Q1’21 and Q2’21, respectively
- The Company confirms that its recently completed Processing and Extraction Center at its Rionegro facility, Colombia’s largest scale processing centre, will be producing extracts in compliance with EU-GMP guidelines by the end of February.
TORONTO and RIONEGRO, Colombia, (Feb. 2, 2021) – PharmaCielo Ltd. (“PharmaCielo” or the “Company”) (TSXV: PCLO, OTCQX: PCLOF), the Canadian parent of Colombia’s premier cultivator and producer of medicinal-grade cannabis extracts, PharmaCielo Colombia Holdings S.A.S., today provided an update on its ongoing Good Manufacturing Practices (GMP) compliance process. As planned, the Company is preparing itself for the GMP audit process in partnership with NODO Interactivo (“NODO”), a consultancy specializing in the implementation and maintenance of GMP and Good Laboratory Practice (GLP) quality management systems for the pharmaceutical, cosmetic, food and related industries. PharmaCielo expects to receive Colombian GMP certification during the first quarter of this year. The Company’s Rionegro facility is Colombia’s largest cannabis processing centre, capable of processing 360 tonnes of biomass annually.
In addition, PharmaCielo Mexico, the Company’s joint venture (“JV”) with MINO Labs S.A. de C.V. (“MINO Labs”), has initiated a GMP pre-audit process. This move comes in tandem with a recent announcement by the Mexican government that it has published a much-anticipated legal framework for the medical cannabis space, including a provision for the import of medicinal extracts and products. PharmaCielo Mexico is positioned to be an early mover in this high-potential market and to become a primary supplier of premium-quality medicinal-grade extracts to the Mexican market. The Company expects to receive Mexican GMP certification during the second quarter of 2021.
Henning von Koss, CEO of PharmaCielo Ltd., commented, “PharmaCielo is one of the very few global suppliers in the market today that was purpose-built to work inside the B2B supply chain where end-product producers, who are already GMP certified, have the responsibility to qualify their suppliers for GMP or EU-GMP compliance as part of their vetting processes. Only a handful of companies in the world today are able to serve these clients by producing cannabinoid input products in compliance with GMP and EU-GMP, and even fewer are doing it at scale. The forthcoming audits in Colombia and Mexico will be important milestones and we expect additional audits both by national authorities to certify, and by clients to qualify, our facilities as we continue to accelerate our global sales pipeline.”
Juan Pablo Herrera Sierra of NODO Interactivo added, “By closely supporting PharmaCielo in the construction and implementation of the GMP roadmap, NODO feels confident in the Company’s ability to achieve INVIMA, COFEPRIS and EU-GMP compliance and further certification successfully. To the best of our knowledge the process scale and capabilities built by PharmaCielo are unparalleled among Colombian cannabis licensed producers making it great news for the industry and the country.”
Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.
PharmaCielo Ltd. (TSXV: PCLO, OTCQX: PCLOF) is a global company, headquartered in Canada, with a focus on ethical and sustainable processing and supplying of all natural, medicinal-grade cannabis oil extracts and related products to large channel distributors. PharmaCielo’s principal (and wholly owned) subsidiary is PharmaCielo Colombia Holdings S.A.S., headquartered at its cultivation and processing centre located in Rionegro, Colombia.
The board of directors and executive team of PharmaCielo are comprised of a diversely talented group of international business executives and specialists with relevant and varied expertise. PharmaCielo recognized the significant role that Colombia’s ideal location plays in building a sustainable business in the medical cannabis industry, and the Company, together with its directors and executives, is executing on a business plan focused on supplying the international marketplace.
This press release contains forward-looking statements. Forward-looking statements can be identified by the use of words such as “expects”, “is expected”, “intends”, “believes”, or variations of such words and phrases or state that certain actions, events or results “may” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include, without limitation, statements with respect to: PharmaCielo’s receipt of Colombian and Mexican GMP certification and the anticipated timing thereof; PharmaCielo’s positioning in the Mexican cannabis market; the potential of the Mexican cannabis market; the effect that the forthcoming audits in Colombia and Mexico will have on PharmaCeilo’s business, including, without limitation, on PharmaCielo’s global sales pipeline; and PharmaCielo’s expectations regarding future audits undertaken by national authorities and clients and the results thereof. Though management believes that its assumptions are reasonable in the circumstances, the actual results, performance or achievements of PharmaCielo’s business may be materially different from any future results, performance or achievements expressed or implied by any forward-looking statements herein. Forward-looking statements can be affected by known and unknown risks, uncertainties and other factors, including, but not limited to: changes to PharmaCielo’s development plans; PharmaCielo’s failure to obtain GMP certification in accordance with anticipated timelines or at all; PharmaCielo’s failure to obtain and maintain all necessary regulatory approvals relating to the sale and export of cannabinoid products, including approval of the TSXV; PharmaCielo’s inability to export or distribute commercial products through sales channels as anticipated due to economic or operational circumstances; unforeseen regulatory developments in the jurisdictions in which PharmaCielo operates, including, without limitation, Colombia and Mexico; risks associated with global economic instability relating to COVID-19; and other risks discussed or referred to under the heading “Risk Factors” in PharmaCielo’s Annual Information Form for the financial year ended December 31, 2019, which is available at www.sedar.com. Accordingly, readers should not place undue reliance on forward-looking statements. Forward-looking statements in this press release are made as of the date of this press release. Except as required by law, PharmaCielo undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.