Our Contract Services
Who We Are and What We Do
Exela Pharma Sciences is a fully integrated large and small molecule sterile injectable development and manufacturing operation. We are located in Lenoir, North Carolina, an hour northwest of Charlotte, an hour east of Asheville, a little over an hour west of Winston-Salem, and about three hours west of the Research Triangle.
Since 2005, we have been helping patients and healthcare givers by bringing to market innovative first-of-its-kind products that result in increased affordability, and greater safety. Our ready-to-use products offer more convenience at the point of care, reduce the risk of contamination and dosing errors, and have longer shelf life. We have a particular focus on eliminating or reducing drug shortages, specifically in the neonatal and/or pediatric populations. We pride ourselves on our compliant quality systems and fast and reliable product development and manufacturing expertise.
We bring our years of experience to the CDMO side of the business with the same passion and sense of urgency. We limit our number of CDMO partners to a select few so that we can offer the rare but essential and much-deserving customer service to each one of them coupled with the “can do” attitude. We go the extra mile to execute under compressed timelines without compromising quality. Over the years we invested in building manufacturing capacity ahead of the actual need to be able to execute light-speed projects. Our state-of-the art laboratories enable in-house development testing and release to improve reliability and offer better control over time and quality of the deliverables.
CDMO Services
Full-service CDMO – From Proof of Concept to Commercialization
Research and Development Services
- Small and Large Molecule Capabilities
- Research and Development, Analytical & Microbiology Service Process
- Development & Formulation Services
Quality & Regulatory Services
- Quality History – 15 FDA inspections since 2010
- Approved by HealthCanada and Australian TPA
- Regulatory filings experience includes 505(b)(2) NDAs, and ANDAs for sterile injections
Manufacturing Services
- Tech Transfer Capabilities
- cGMP Parenteral Drug Product Manufacturing Capabilities
- Medium-speed and High-speed Vial Filling Lines
- IV Bag Filling Line
- High-speed Pre-Filled Syringe Filling Line,
- Lyophilization Services
- Aseptic and Terminal Sterilization Capabilities
- Controlled Drug Products with State-of-the-Art DEA Vault
- Stability Programs
- Automated Inspection, Automated Labeling and Automated Packaging Capabilities
Warehouse and Logistics
- Warehousing
- Biorepository Storage Capabilities including ultra-low temperature and 2-8 oC
- Global Distribution Capabilities