Exela’s Pharmaceutical Products

FDA-Approved Sterile Injectables

Exela^® is a FDA-approved manufacturer of prescription injectable pharmaceuticals, as well as an FDA-approved Outsourcing Facility that provides select drug shortage sterile injectable products via the 503B regulatory pathway. In fact, in 2013 Exela became the first cGMP manufacturer to be licensed as an Outsourcing Facility in response to requests from customers in need of products to ease drug shortages. Exela^® focuses on developing and manufacturing high-quality prescription drugs and has developed many first-to-market generics that have saved patients millions of dollars.

Beginning with the establishment of its commercial infrastructure in 2015, Exela has brought to market internally developed finished injectable products. We currently market a combination of generic and proprietary sterile injectable products with high barriers to market entry, via an Abbreviated New Drug Approval (ANDA) or 505(b)(2) NDA regulatory pathway. We strive to improve patient outcomes while reducing overall healthcare costs by developing products that improve the treatment experience such as easing the burden of administration, providing an improved safety profile, faster drug preparation, or reduced drug waste.

Our products are manufactured to strict cGMP standards that meet or exceed all regulatory standards. Quality is built into each product from the ground up, including the procurement of raw materials and components, to the training of our employees, to the manufacturing of our products via state-of-the-art equipment. These same services and capabilities are offered to our CDMO drug formulation and fill finish customers.