SUNRISE, Fla., Dec. 09, 2025 (GLOBE NEWSWIRE) --
Transpire Bio, an integrated, clinical-stage biopharmaceutical company focused on developing inhaled therapeutics for pulmonary and systemic diseases, today announced that the U.S. FDA has completed a Pre-Approval Inspection (PAI) at its manufacturing facility in Weston, Florida, with a Voluntary Action Indicated (VAI) classification. The company has now received the Establishment Inspection Report (EIR) for the facility, signifying its state of compliance with current good manufacturing practices (cGMP).
“We have worked diligently to build world-class manufacturing facilities here in the U.S. along with our U.S.-based supply chain. Compliance is the top priority at Transpire Bio, and receiving this EIR for our first facility following our first-ever PAI demonstrates our commitment to quality. The closure of the PAI by the U.S. FDA marks an important milestone for Transpire Bio,” said Dr. Xian-Ming Zeng, Chief Executive Officer of Transpire Bio. “Our team in South Florida has extensive expertise in developing and manufacturing inhaled medicines, and the closure of this PAI is the result of the dedication and focus of our very talented team,” said Todd Lewis, Head of Technical Operations at Transpire Bio.
About Transpire Bio Inc.
Transpire Bio Inc. is an integrated, US-based, revenue-generating, clinical-stage biopharmaceutical company headquartered in Sunrise, Florida. Transpire Bio harnesses its inhaled drug delivery expertise to improve patients’ lives by expanding access to important therapies and developing treatments for serious diseases where therapeutic options are significantly lacking. Transpire Bio has developed multiple proprietary inhalation technology platforms, including dry powder inhalers and soft-mist inhalers. Transpire Bio is building a pipeline of innovative inhalation medicines for Idiopathic Pulmonary Fibrosis (IPF) where it has three assets in development. Transpire Bio is also developing therapies for Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, Parkinson's Disease Psychosis, and Glioblastoma.
For more information, please visit www.transpirebio.com
Corporate Inquiries
info@transpirebio.com
+1 954.908.2233
Investor Inquiries
Stuart Loesch
Chief Commercial Officer, Transpire Bio
Stuart.Loesch@transpirebio.com
