MediPharm Labs & Bedrocan

Has anyone on this forum had dealings with MediPharm Labs or Bedrocan?

One of our team worked for Bedrocan and I’m pretty familiar with both companies.
Bedrocan was the first company to develop GMP flower and licensed their technology to Canopy which allowed the latter to become significant players in the Canadian industry early on.
MediPharm are a Canadian company with Australian facility

Both are very much in the international medical cannabis space.

What do you need to know?

1 Like

Somebody should really ask who ever is in charge of gmp how the F;?)& a flower can be GMP and who is checking
Bedrocan is the monopoly of legal cannabis
Try to find out who s behind and funny enough no paper trail can be found no nothing
Democracy :joy: this stinks

5 Likes

Any processed, dried herbal product can be GMP providing it is consistent and and tests clean reliably - took us ages to work out how Bedrocan and Canadian companies achieved this but now it’s pretty clear. Does require a lot of time in validation and testing, with stability testing and microbiology being the biggest challenge.

AHPA has some good resources for this:
http://www.ahpa.org/Resources/GACP-GMPAssessmentTools.aspx

4 Likes

@elchemy Thank you for the attached link to AHPA. This is an extremely useful resource.

I have been in the process of verifying EU-GMP license holders and besides these 2 before mentioned companies I am interested if anyone has had good experiences with other license holders?

http://eudragmdp.ema.europa.eu/inspections/gmpc/searchgmpcompliance.do

@elchemy Do you know are more recently licensed operations able to get away with accelerated stability testing for approval or are they typically targeting the standard year long stability?

@Sacextraction groups definitely run accelerated stability studies but some regulators still require normal results, as I understand it - so it can be a stop-gap measure but not generally suitable for full registration etc.
Especially as cannabis products are new/controversial in regulated medical markets.

1 Like

I see MediPharm Labs has partnered up with OTT Healthcare in Canada to enter into clinical trials on their cannabinoid formulation. I guess this means MediPharm is sitting on a registered DMF (drug master file) that meets requirements for IND Phase 1 requirements. Does anyone else have a list of companies with DMFs ready to move into Phase 1 clinical?

https://www.globenewswire.com/news-release/2020/10/19/2110298/0/en/MediPharm-Labs-Initiates-Clinical-Trial-for-Use-of-Cannabis-to-Treat-Chronic-Kidney-Disease-Patients-and-Improve-Quality-of-Life.html

1 Like

Folium has also gone down this path. I assume Mile High Labs and other bigger players are too. If not they should have.
Not sure how far along they are but it’s on their radar

1 Like