Manufacturing

Scalable supply chain for partnership and growth

Orexo has established a scalable, commercial ready supply chain for the development and manufacturing of powder-based medications. This enables partners to accelerate development timelines, reduce risks, and achieve cost-efficient progression from concept to market.

Orexo has established a supply chain for its own products: Izipry™, an opioid overdose emergency medication and OX640, also an emergency medication but for treatment of anaphylaxis. This infrastructure is a strategic asset that not only supports Orexo’s internal development portfolio, but also offers significant advantages to partners seeking rapid, reliable, and cost-efficient development of powder-based medicines.

High stability enables cold chain elimination and simplified distribution

Superior thermal stability minimizes degradation risks and eliminates the need for a cold chain, enabling simple and cost-efficient global distribution, even in resource limited settings. Orexo’s powder formulations extend shelf life, protect sensitive compounds such as biologics and vaccines, and reduce the risk of microbial contamination. All are critical qualities for emergency treatments and high volume deployment.

Developing these capabilities has required substantial investment in advanced manufacturing technologies, together with two specialized CDMOs¹ and a worldleading drug delivery device manufacturer.

Through dedicated research and development activities, Orexo has refined a spray-drying process that achieves precise particle size control. Spray-dried powders with co-localized components eliminate segregation, de-risking scale-up and ensuring reliable commercial manufacturing.

To further safeguard product integrity, the team has also developed moisture protective secondary packaging integrated with the device.

Experience in managing risk and regulatory manufacturing ecosystem

Regulatory requirements for drug-device combination products are stringent, particularly in emergency use. Orexo has built valuable experience through programs such as Izipry, currently under FDA review for market approval. This includes governance, documentation, and manufacturing processes that meet strict regulatory expectations for reliability.

Orexo works with one of its two CDMO partners to operate the manufacturing chain and conduct analytical testing, maintaining a scalable, FDA-inspected commercial manufacturing process designed to support the FDA 99.999 percent reliability requirements for emergency medications.

Faster and safer delivery of critical treatments

This manufacturing platform strengthens Orexo’s ability to scale internal projects and positions the company as a valuable development partner for powder-based medications. By combining proven technology, regulatory experience, and commercial ready manufacturing, Orexo enables partners to drive value, reduce technical and operational risks, and accelerate development timelines.

1. Contract Development and Manufacturing Organization.