Kindeva Drug Delivery’s Woodbury Analytical Services Site: Inspected by the FDA
16 July 2024 - 10:00PM
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.
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Holli Kroeker +1 308-338-2358 pr@scorrmarketing.com