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 highly potent compound, a variety of particle engineering capabilities and drug product continuous services. The site was first inspected by the FDA in 2007 and hence has had an excellent track record with multiple regulatory authorities around the globe.

The Hovione New Jersey site is again expanding its capacity in the U.S. This will begin in early 2024 with an additional pharmaceutical spray dryer size 2 at our existing building at 40 Lake Drive. The New Jersey campus has welcomed a new building located at 89 Twin Rivers Drive. This is an adjacent building which will carry the same FDA registration number and contain two state of the art pharmaceutical spray dryers size 3. This new building will commence operations of each of its spray dryers in late 2024 and early 2025 respectively. Our continued growth will use the latest technologies to best serve our partners and patients by providing an integrated offering from Drug Substance to Drug Product at Hovione in New Jersey.

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 and 0.03µg/m3  OEL
• 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).