Exela Pharma Sciences is located in Lenoir, North Carolina, in the foothills of the scenic Blue Ridge Mountains. Our cGMP compliant facility consists of 20,000 square feet of cGMP manufacturing space, 17,000 sf of cGMP warehousing space, 240,000 sf for future expansion, and 15,000 sf of modern laboratory space.
We only manufacture to the highest standards
We currently have the capability to meet all of our immediate market demands and expected demand for the near future. Consistent with our growth projections, we are investing to expand our manufacturing capacities both vertically and horizontally to offer product presentations that include vials, syringes and bags as well as lyophilized products.
Exela utilizes a state-of-the art manufacturing system, designed to eliminate cross-contamination between products, improve manufacturing efficiency and flexibility. Our facilities have been inspected by the United States Food & Drug Administration (FDA) nine times since 2010. Exela is also approved by HealthCanada to supply product for Canadian market. The compounding, filling, testing and releasing of all of our products is performed under strict cGMP standards, and under one quality system.
Our modern laboratory space includes Microbiology, Chemistry and Bio-analytical areas:
The Microbiology Laboratory is equipped with state-of-the-art automated microbial species identification technology, utilized in the testing of more than 800 samples per week for microbiological compliance. Full microbiologic testing of raw materials, finished products and environmental monitoring is performed regularly.
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 and FT-IR.