Regeneronreason 03 of 4it makes it for less than anyone else canderived 2026-09-08accession 0000872589-26-000025
We have large-scale manufacturing operations in Rensselaer, New York and Limerick, Ireland
We constructed a fill/finish facility in Rensselaer, New York that is currently undergoing process validation
no findingread · nothing bore on it
It held on this filing. No finding was written because nothing in it bore on the reason — the sentences it was read against are below.
the evidence · every sentence checkedthree sentences · whole, uncut
the claims it rests on
“We have large-scale manufacturing operations in Rensselaer, New York and Limerick, Ireland”
“We constructed a fill/finish facility in Rensselaer, New York that is currently undergoing process validation”
what it was checked against
fill/finish manufacturing arrangements
“maintaining and successfully monitoring commercial manufacturing arrangements for our marketed products with third parties who perform fill/finish and bulk product manufacturing or other steps in the manufacture of such products to ensure that they meet our standards and those of regulatory authorities, including the FDA, which extensively regulate and monitor, and have been increasing their focus on, pharmaceutical manufacturing facilities;”