Post by
Brassnut on Jan 29, 2018 2:33pm
On Nuuvera and GMP certification
Tetra is waiting on Aphria to get GMP certification before Health Canada will approve phase 3 ppp001 as per this... https://m.marketwired.com/press-release/tetra-bio-pharma-provides-update-on-status-its-phase-3-clinical-trial-application-lead-2242969.htm And this was part of the news release today... Provides Access to State-of-the-Art Testing and Extraction Facilities: The combined company, through Nuuvera, has access to the only standalone Health Canada GMP-approved facility that is authorized and dedicated under its controlled drugs and substances licence to conduct commercial scale activities with respect to cannabis and cannabinoids. This state-of-the-art medical laboratory enables Nuuvera to maintain the highest standards by adhering to both Health Canada and FDA pharmaceutical GMP guidelines, ensuring product safety, quality, and efficacy. Sounds like that GMP certification just came through!
Comment by
TheBossCwC on Jan 29, 2018 3:53pm
Sorry for my novice html skills. Also meant to say Aphria acquires Nuuvera on Jan 29th, but Nuuvera acquired Medalchemy. In the end it looks like TBP now has access to a GMP Certified Lab which is welcomed by the company from its manufacturing partners a.k.a Aphria..... unless im way off
Comment by
MaceWindu on Jan 30, 2018 10:47am
While I do like the deal as well for the long term, doesn't this mean we won't have access to the GMP we need to start PPP001 trials until April now given that the deal is expected to close in April? Please correct me if I'm wrong.
Comment by
MaceWindu on Jan 30, 2018 10:49am
...assuming Aphria is not still going to pursue their own after announcing this acquisition.
Comment by
Ripsanddips on Jan 30, 2018 11:20am
NUU's GMP cert is for oil HC requested GMP cert fromAPH for the API used in PPP001 2 totally different things
Comment by
LeafRider on Jan 30, 2018 11:45am
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