The Hovione New Jersey site commenced operations in 2002 providing process development and small volume API manufacturing. Since then its technologies portfolio has greatly expanded with additional offerings in potent compounds, a variety of particle engineering capabilities including small and large scale Amorphous Solid Dispersions by spray drying and drug product continuous tableting services. The site was first inspected by the FDA in 2007 and recently received a “zero” observation inspection from the FDA and maintains an excellent track record with multiple regulatory authorities around the globe.

The site is again expanding its capacity in the U.S. with the recent addition of a size 2 pharmaceutical spray dryer at our existing facility at 40 Lake Drive. In addition a new adjacent facility located at 89 Twin Rivers Drive is in the process of being commissioned. and will house two state of the art size 3 pharmaceutical spray dryers. Commercial operation of these new spray dryers is planned for mid-2026 and late 2026 respectively. Our continued growth in New Jersey will leverage the latest technologies to best serve our customers and patients with an integrated offering from Drug Substance to Drug Product.

Areas of Focused Expertise

The site boasts strong capabilities and physical assets in the following areas:

• API Manufacturing Plants - Fully Automated Pilot Plant for (100L to 3000L)
• Highly Potent API handling - Down to 1µg/m3
• Cryogenic - Volume 100L to 2400L, Temperature Range -75 to 150ºC
• Continuous Drug Product - Wet & Dry Granulation, Direct Compression, Real time release  
• Pharmaceutical Spray Drying - Size 1, Size 2, and Size 3 capabilities
• Hot Melt Extrusion - Pilot Scale 18mm pharma twin screw extruder (co-rotating)
• Milling Technology - Wet milling

For details about production equipment – click here

Operations

• Hovione New Jersey plant operates 24 hours a day 5 days a week
• Quality Control labs support production 24 hours a day 5 days a week

Certifications

The site was rewarded with VPP Star Award by the Occupational Safety and Health Administration (OSHA) in 2007 and has successfully maintained this status since.

Hovione New Jersey is certified for the Customs-Trade Partnership Against Terrorism (C-TPAT) by the U.S. Customs and Border Protection (CBP).