Kindeva's Woodbury Facility Gains FDA Classification

Kindeva Drug Delivery's Woodbury, MN facility received FDA classification following a successful inspection, reaffirming its commitment to supporting clients through its global business unit for analytical services. Launched this year, the unit provides comprehensive analytical services to pharmaceuticals, biopharmaceuticals, and medical devices, both integrated and stand-alone.

Kindeva Drug Delivery's Woodbury facility has achieved FDA registration and Voluntary Action Indicated (VAI) classification for cGMP compliance. Following a Prior Approval Supplement (PAS) submission on February 29, 2024, seeking approval as an alternate finished product test site for Proventil HFA Inhalation Aerosol, the FDA conducted an inspection from April 1-3, 2024. Approval for the PAS was granted on June 20, 2024. Moving forward, the Woodbury site is slated for routine cGMP surveillance audits.

Kindeva Vice President of Analytical Services Jennifer Riter, said “We are delighted to have VAI status for the first time in our analytical services laboratory at our Woodbury site. As a result of our FDA registration and our requested approval of Kindeva Drug Delivery L.P. located in Woodbury as an alternate finished product test site, this was a great opportunity for Kindeva to host the FDA for an inspection. The successful outcome demonstrates Kindeva’s laboratory as an established site to continue supporting our customers with analytical services as they bring their products to market.”