State-of-the-Art Facilities
Over 400,000 Square Feet of cGMP Space
Exela® Pharma Sciences cGMP-compliant facilities are located in the beautiful foothills of the Blue Ridge Mountains in Lenoir, North Carolina, just an hour northwest of Charlotte-Douglas International Airport and three hours from the Research Triangle.
Our campus consists of multiple distinct CDMO and fill-finish facilities within a short distance of each other and is designed with long-term growth in mind. These cGMP facilities have increased our manufacturing capacity to produce millions of units of liquid vials, lyophilized vials, aseptic and terminally sterilized IV bags, and pre-filled syringes per year.
Our Facilities
- Corporate Headquarters: Administrative Offices, R&D Labs, QC/QA, Biorepository on 42-acre site
- Primary Manufacturing: High Speed Vial Lines, High Speed Pre-Filled Syringe Lines on 15-acre site
- Secondary Manufacturing: Multiple Aseptic Vial Lines, TS IV Bag Line, LYO Suite on 7-acre site
- Downstream Facility: Automated Inspection, Labeling & Packaging, Warehousing, and Distribution on 10-acre site
- Additional Capacity: Multiple buildings and lots ready for future expansion
Laboratory Space
Our laboratory spaces house dedicated Microbiology, Chemistry, and Bio-analytical areas, all staffed by an experienced science team.
The Microbiology Laboratory conducts testing of raw materials, finished products, and all aspects of environmental monitoring to support our commercial manufacturing. Our modern equipment includes automated microbial species identification technology, walk-in incubators, and sterility testing isolators.
The Chemistry and Bio-Analytical facility is supported by state-of-the-art, fully validated, and calibrated spectroscopy and chromatography instrumentation, including:
- HPLC and UPLC
- GC
- AA
- ICP-MS
- LC-MS
- FT-IR
Exceptional Regulatory Track Record
Exela® develops and manufactures products for its own label as well as provides contract manufacturing and development services for others who desire a qualified US-based organization to fulfill their requirements. We utilize manufacturing processes that are designed to eliminate cross-contamination between products while improving manufacturing efficiency and flexibility.
Our CDMO and fill-finish facilities have been inspected by the United States Food & Drug Administration (FDA) over 15 times since 2010. Exela® is also approved by Australia and HealthCanada to supply products for those markets. The compounding, filling, testing, and releasing of all of our products are performed under strict cGMP standards, and under one, fully harmonized quality system.