Kindeva Drug Delivery

Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) that specializes in drug-device combination products. The company develops and manufactures a wide range of drug-delivery formats, including pulmonary and nasal, injectable, and transdermal products. Kindeva’s service offerings cover the entire product lifecycle, from early-stage feasibility studies to commercial-scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Serving a global client base, Kindeva operates state-of-the-art manufacturing, research, and development facilities across the U.S. and U.K., encompassing approximately 1 million square feet of cGMP-compliant space across ten facilities. Kindeva has a rich history of innovation, having invented the pressurized metered-dose inhaler (pMDI) in 1956 and the emergency use autoinjector in 1959. The company also developed the first commercially available dose counter in 2010 and the CFC-free nasal MDI in 2012. Currently, Kindeva is working on low-GWP inhalers and plans to open one of the first commercial-scale green propellant lines in 2024. Kindeva offers full-service CDMO capabilities for both mono and combination transdermal product therapies and has developed microneedle array patches for accurate intradermal delivery of various molecules, including vaccines and biologics. The company’s aseptic injectable fill-finish facility in Bridgeton, Missouri, is designed for maximum efficiency, compliance, and patient safety, adhering to Annex 1 standards. Kindeva has also installed pilot scale lines and new manufacturing lines capable of filling inhalers with HFA-152a and HFO-1234ze propellants. Their analytical services ensure product quality and regulatory compliance, while their regulatory services include dossier preparation, global submissions, and strategic planning. Kindeva is committed to sustainability, leading the transition to greener propellants and environmentally friendly combination products. Since 1958, Kindeva has manufactured over 250 million autoinjectors, providing life-saving emergency therapies worldwide. The company’s new aseptic injectable fill-finish site in Bridgeton, Missouri, is set to open in 2024. Kindeva’s serialization processes ensure each product is uniquely identified, authenticated, and tracked, reducing risks associated with counterfeiting and diversion.