WOODBURY, Minn.--(BUSINESS WIRE)--Global drug-device combination product CDMO Kindeva Drug Delivery today announced that their Woodbury, MN facility has been inspected, successfully classified by the FDA, and continues to support clients through the analytical services global business unit. The new business unit, launched earlier this year, supports both integrated and stand-alone analytical services for the pharmaceutical, biopharmaceutical, and medical device sectors.
Kindeva’s analytical services site in Woodbury is now FDA registered and classified as Voluntary Action Indicated (VAI) with regards to cGMP. A Prior Approval Supplement (PAS) was submitted February 29, 2024, requesting approval of Kindeva Drug Delivery L.P. located in Woodbury as an alternate finished product test site for Proventil HFA (albuterol sulfate) Inhalation Aerosol. The FDA inspected Woodbury April 1-3, 2024, and the PAS was approved June 20, 2024. The Woodbury site is now on the list for routine cGMP surveillance audits moving forward.
“We are delighted to have VAI status for the first time in our analytical services laboratory at our Woodbury site,” said Kindeva Vice President of Analytical Services Jennifer Riter. “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.”
About Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization focused on drug-device combination products. We develop and manufacture products across a broad range of drug-delivery formats, including pulmonary & nasal, injectable, and transdermal. Our service offerings span early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva serves a global client base from our state-of-the-art manufacturing, research, and development facilities located across the U.S. and U.K.
