RE:Question on back up facility for Egrifta "We do not own or operate manufacturing facilities for the production of EGRIFTA S/® and tesamorelin, nor do we have plans to develop our own manufacturing operations in the foreseeable future. We currently rely on Bachem and Jubilant to manufacture and supply all of our required raw materials, drug substance and drug product for sales of EGRIFTA S/®. We will also rely on a single third-party supplier, Lyophilization Services of New England ("LSNE") for the manufacture of the F8 Formulation. We have not qualified alternative manufacturers to date and no assurance can be given that such manufacturers will be qualified in the future or receive necessary approvals. There are a limited number of third-party suppliers that are compliant with current good manufacturing practice, ("GMP"), and that also have the necessary expertise and capacity to manufacture our drug substance and drug product."
They don't have a back up manufacturer for Egrifta SV and will be relying on a "single supplier for F8" despite the fact that Egrifta is absolutely their main commercial product.
https://www.theratech.com/static-files/e2cd4c2e-6d00-4f3d-9197-f588856fa98e
palinc2000 wrote: Levesque did not provide an answer and he asked Dubuc to reply.....
Same reaction for other questions on other subjects
He and Kamala have things in common !!!