RE:Agree our "global pharma partner" is NOT Apotex, it is a s1i, I still think Medipharms generic global pharma partner is likely Apotex as per the ANDA + paragraph IV filed with the FDA in late Nov 2022 to challenge Jazz Epidiolex 303 patent. One thing for sure is Labs partner will be one of the defendants named in the Epidiolex lawsuit.
- In partnership with a large global pharmaceutical company, in 2022 MediPharm contributed active pharmaceutical ingredients to an Abbreviated New Drug Application filed with the United States Food and Drug Administration.
- “No earlier than November 28, 2022, Apotex sent written notice of a Paragraph IV Certification (“Apotex’s Notice Letter”) to Jazz. According to Apotex’s Notice Letter, Apotex filed an ANDA pursuant to Section 505 of the FFDCA
- The Company has provided a full response to the US Food and Drug Administration (FDA) in relation to the initial foreign drug site inspection of its Barrie facility regarding a new Drug Master File (DMF) being referenced in a recent Abbreviated New Drug Application (ANDA). This is the first US FDA Audit of a purpose-built commercial cannabis facility in Canada. MediPharm continues in-depth correspondence with the FDA regarding its November 2022 on-site inspection related to Drug Master File being submitted as part of an Abbreviated New Drug Application (ANDA) submission by an international pharmaceutical partner.
A traditional global partner and any NDA's filed with the FDA will be something very different and just as exciting if happening.
I havent been able to find to much regarding any NDA's filed in conjunction with Medipharm, but I will keep looking.