PharmaCielo Receives Confirmation of Colombian Phytotherapeutics GMP Certification
September 14, 2021
- PharmaCielo Receives Confirmation of Colombian Phytotherapeutics GMP Certification
- GMP[i] certification has been confirmed by INVIMA.
- The certification covers Phytotherapeutics manufactured with PharmaCielo´s extracts and proprietary cultivars.
- PharmaCielo’s Processing and Extraction Centre – the largest in Colombia and one of the largest globally – has been in compliance with EU-GMP[ii] guidelines since February 2021 and the Company expects to achieve EU-GMP certification in H1-2022.
TORONTO, Canada and RIONEGRO, Colombia (September 14, 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 announced that it has achieved Colombian GMP Certification for Phytotherapeutics manufactured with its extracts and proprietary cultivars from the Colombian National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, (“INVIMA”). The Company’s Rionegro facility is Colombia’s largest cannabis processing centre, and one of the largest in the world today, capable of processing 360 tonnes of biomass annually.
Bill Petron, CEO of PharmaCielo, commented, “GMP certification is the gold standard for the quality assurance of extract production globally, and PharmaCielo’s achievement of this milestone confirms that the Company’s processes and products are world class. The next step for PharmaCielo is the achievement of EU-GMP certification. We have already been producing to EU-GMP standards since early 2021, are launching an independent audit with a potential customer in the coming weeks and are on track to receive formal certification six months thereafter. PharmaCielo has a portfolio of high-quality, GMP certified Phytotherapeutics, Colombia’s largest cultivation, processing, and extraction footprint, a global low-cost advantage, and a robust sales pipeline. We are positioned to scale and generate value for shareholders.”
Grant of Restricted Share Units and Stock Options
Effective September 14, 2021, the Company has granted an aggregate of 1,375,000 Restricted Share Units (“RSUs”) and an aggregate of 550,000 stock options to directors, officers and employees. The options vest over three years, are exercisable at a price of $1.25 per share and expire five years from the date of grant. 1,125,000 RSUs vest immediately and 250,000 RSUs vest one year from the date of grant. The RSUs and options are granted pursuant to the Company’s RSU plan and stock option plan, respectively.
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.
For further information:
Ian Atacan, Chief Financial Officer
International: Gal Wilder, Cohn & Wolfe
This news release contains forward-looking statements. Forward-looking statements can be identified by the use of words such as “expects”, “is expected”, “intends”, “anticipates”, “believes”, or variations of such words and phrases or state that certain actions, events or results “may” or “will” be taken, occur or be completed or achieved. Forward-looking statements in this news release include, without limitation, statements with respect to: expectations that new cannabis-derived product categories will be developed and sold domestically and for export; expectations that the Decree and related regulations will improve the Company’s, industry’s, and local competitiveness; expectations that additional THC product types, including dried flower, will be developed, sold, or exported; expectations that the Colombian government will continue to support the development of the cannabis industry’s competitiveness; expectations that PharmaCielo will benefit from the Decree and regulations introduced today; expectations that the Decree and regulations will drive forward PharmaCielo and the Colombian cannabis market; expectations that a broader array of business opportunities will exist for PharmaCielo to collaborate with Colombian end-product manufacturers for the development of new products for local and international consumption; expectations that cannabis extracts producers will be able to commercialize and export low-THC derivatives and input materials; and that the requisite additional consultations and implementation of the necessary technical regulation will occur. .
The forward-looking statements in this news release are necessarily based on assumptions, including assumptions with respect to: PharmaCielo’s ability to execute its business plan, PharmaCielo’s ability to obtain necessary regulatory approvals for the export of its products from Colombia and import of its products into other countries, sufficient demand for the Company’s products, that potential customers will be satisfied with the results of audit processes, that any changes to Colombian cannabis legislation will not negatively impact the Company’s business, that the Company will be able to locate and retain necessary personnel to achieve its business goals, PharmaCielo’s ability to maintain its distribution contracts in good standing and the accuracy of PharmaCielo’s projections regarding the market for cannabinoid products.
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 in this news release. Forward-looking statements can be affected by known and unknown risks, uncertainties and other factors, including changes to PharmaCielo’s development plans, the failure to obtain and maintain all necessary regulatory approvals relating to the export of cannabinoid products and the import of these products into other countries, TSXV approval, the inability to export or distribute commercial products through sales channels as anticipated due to economic or operational circumstances, risks associated with operating in Colombia, fluctuation of the market price for the Company’s products, risks associated with global economic instability relating to COVID-19 or other developments, risks related to retention of key Company personnel, currency exchange risk, competition in PharmaCielo’s market 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. 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.
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.
[i] Good Manufacturing Practices
[ii] European Union Good Manufacturing Practices