Liminal BioSciences receives FDA approval for US-based manufacturing
Liminal BioSciences is now FDA licensed to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S.
LAVAL and CAMBRIDGE — Liminal BioSciences Inc., a clinical-stage biopharmaceutical company, announced that the Company’s wholly-owned subsidiary, Prometic Plasma Resources (USA) Inc., has received U.S. Food and Drug Administration approval for its plasma collection center located in Amherst, NY.
The center commenced operations and initiated source plasma collection in early 2020, and is now FDA licensed to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S. The approval follows the FDA’s pre-licensure inspection in September 2020.
“FDA approval of our second plasma collection facility, and first outside of Canada, is an important milestone that enables us to continue to internally supply a portion of our raw material, or sell to other customers,” stated Bruce Pritchard, Chief Executive Officer of Liminal BioSciences. “I am pleased that we obtained approval of this center well ahead of our expected timelines and we are grateful to our dedicated staff for helping achieve this important milestone.”