ËÄÉ«AV

The ËÄÉ«AV 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 compounds, a variety of particle engineering capabilities and drug product continuous tabletingÌýservices. 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 ËÄÉ«AV New Jersey site is again expanding its capacity in the U.S. with the addition of a size 2 spray dryer at our existing facility at 40 Lake Drive, ready for commercial launch in late 2024.Ìý

The New Jersey campus has welcomed a new facility 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 size 3 pharmaceutical spray dryers. Commercial operation of these new spray dryers is planned for late 2025 and mid 2026 respectively. Our continued growth will leverage the latest technologies to best serve our customers and patients with an integrated offering fromÌýDrug Substance to Drug Product at ËÄÉ«AV in New Jersey.

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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 handlingÌý- Down to 1µg/m3 and 0.03µg/m3 ÌýOEL
• CryogenicÌý- Volume 100L to 2400L, Temperature Range -75 to 150ºC
• Continuous Drug Product - Wet & Dry Granulation, Direct Compression, Real time release Ìý
• PharmaceuticalÌýSpray Drying - Size 1, Size 2, and Size 3 capabilities.
• Hot Melt Extrusion - Pilot Scale 18mm pharma twin screw extruder (co-rotating)
• Milling TechnologyÌý- Wet milling

For details about production equipment –Ìýclick here

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Operations

• ËÄÉ«AV 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.

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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.

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

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