Quality

Excellence in QUALITY is our first priority…Without it, you have nothing

Exela manufactures and supplies sterile pharmaceutical products that are injected straight into the bloodstream or instilled directly onto the eye. It is imperative that our sterile products are Safe, Pure and Effective. Ensuring patients receive high quality product requires Exela to begin with high quality materials. Therefore, we focus on procuring high quality container closure materials such as glass, stoppers, etc., as well as high quality excipients and active drug substances. These materials are rigorously tested prior to being used in the manufacturing of our finished product.

Equally important is the design of our facilities, processes and equipment, and training of our employees to deliver quality products (“Quality by Design” or “QbD”). Delivering excellence in Quality begins with a Quality by Design (QbD) process. Our Quality systems are built from the ground up to ensure utmost compliance to regulatory agencies’ guidelines. The QbD approach begins with the drug development phase and continues throughout the clinical testing, regulatory filing, approval and manufacturing stages. The robustness of our QbD is reflected in our stellar FDA approval and inspection record.