DanCann Pharma A/S Provides Positive Insight on Progress of Cannabis Bulk Product Approval
COPENHAGEN, Denmark, 14 March 2023 - DanCann Pharma A/S (SS: DANCAN) (OTCQB: DCPXF) ("DanCann Pharma" or the "Company"), a Danish company powered by cannabinoids, hereby provides positive insight on the progress of cannabis bulk product (the “Product” or “Cannabis Flos”) approval from its EU-GMP facility, Biotech Pharm1.
DanCann Pharma has established a new benchmark in the cannabis industry by completing additional microbial testing in conjunction with a microbial suitability and verification study. Results from the testing showed levels 5,000 times lower than the legal requirements.
To achieve this, DanCann Pharma first validated its testing during a suitability study for microbiological testing, which yielded satisfactory results. Actual testing was then done in accordance with validated EP and USP methods for microbial examination of non-sterile products to confirm the purity of the Product. The tests conducted included Total Aerobic Microbial Count, Total Yeast and Mold Count, Bile-Tolerant Gram-Negative bacteria, Escherichia coli, and Salmonella Spp.
The results of these tests have reconfirmed DanCann Pharma's previous claims that its Product is exceptionally pure and free from any contamination, even without the use of radiation. DanCann Pharma's results for TAMC and TYMC are 5,000 and 50 times lower than the legal requirement, respectively. This is a distinctive characteristic of DanCann Pharma since other manufacturers often resort to post-processing methods and steps, such as irradiation, due to their conventional production techniques.
DanCann Pharma produces their biomaterial using the best practices from the pharmaceutical industry in combination with advanced environmentally controlled cultivation technology and vertical cultivation. No soil or other media is being used, but a specially developed system that adds the necessary fertilizers and nutrients. The automated cultivation processes and minimized external product contact have created significant results so far.
The values obtained from the testing were as follows:
| Tests: | Results: | Requirements: |
| TAMC (Total Aerobic Microbial Count): | < 10 CFU/g | 50 000 CFU/g |
| TYMC (Total Yeast and Mold Count): | < 10 CFU/g | 500 CFU / g |
| Bile-Tolerant Gram-negative bacteria: | Absent | 102 CFU / g |
| Escherichia coli: | Absent | Absent |
| Salmonella Spp.: | Absent | Absent |
It is important to note that the microbial suitability study verified that the testing and methods used are in accordance with European Union Good Manufacturing Practice standards.
Regulatory agencies, such as the Danish Medicines Agency, require this type of testing to ensure that manufacturers are adhering to GMP standards and producing high-quality products. Therefore, DanCann Pharma's completion of both the microbial suitability study and subsequent testing demonstrates their commitment to producing a safe and high-quality product for patients without additional processing steps such as irradiation.
By being able to avoid the irradiation step entirely, DanCann Pharma is able to conserve and preserve the valuable ingredients and active components found within the flower, while reducing significant post-processing costs.
In addition, several markets and customers have opposition towards of irradiation threated products, including states in Germany.
About DanCann Pharma
DanCann Pharma A/S (SS: DANCAN) (OTCQB: DCPXF) was founded in 2018 and is a Danish biopharmaceutical Company powered by cannabinoids. DanCann Pharma is a licensed production and distribution Company.
The Company focuses on discovering, developing, manufacturing, and commercializing new therapeutic cannabinoids in a wide range of disease areas.
DanCann Pharma is EU-GMP-approved by the Danish Medicines Agency under the Danish Pilot Programme for medical cannabis, and have, among other things, license for manufacturing, export, import and distribution. The DanCann Pharma group also owns the subsidiary CannGros ApS, which is the market leader in Denmark with the import and distribution of the products Bedrocan®, Bedica® and Bediol® to all the Danish pharmacies.
DanCann Pharma A/S (SS: DANCAN) is listed on the Spotlight Stock Market in Copenhagen/Stockholm and sidelisted on OTCQB Venture Market in USA (OTCQB: DCPXF).
For more information, visit: www.dancann.com
For further information, please contact:
Jeppe Krog Rasmussen, CEO
E-mail: [email protected]
Forward-looking-statement:
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events, or developments that the Company believes, expects, or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology.
Forward-looking statements are subject to several risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities.
Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this presentation are made as of the date of this presentation and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
