Exela Pharma

Exela Pharma Sciences, established in 2005 by Phanesh Koneru, operates as an integrated specialty pharmaceutical company based in Lenoir, North Carolina. The company's trajectory began as a contract research organization (CRO), developing products and forming partnerships with injectable manufacturers. A significant milestone was the 2008 acquisition of its first manufacturing facility in Lenoir, which initiated its transformation into a contract development and manufacturing organization (CDMO). This evolution enabled the firm to manage the entire pharmaceutical lifecycle, from drug substance development to marketing finished products.

The founder, Phanesh Koneru, who serves as President and CEO, has a unique background that blends science and law. Before establishing Exela, he was the Vice President of Intellectual Property at Watson Pharmaceuticals and began his career as a registered pharmacist, a role he held for twelve years. His academic credentials include a Ph.D. in Biomedicinal Chemistry, a Juris Doctor (J.D.), and a Master of Laws (LL.M). This multidisciplinary expertise underpins the company's strategy. Exela's other founder is Murthy Mallipeddi, who holds the position of Chief Scientific Officer.

Exela's business model is twofold, encompassing both the production of its own line of pharmaceutical products and offering CDMO services to a client base that ranges from local hospitals to Fortune 500 pharmaceutical companies. The company specializes in sterile injectable and ophthalmic products with high barriers to market entry, utilizing regulatory pathways like the Abbreviated New Drug Application (ANDA) and 505(b)(2) applications. A key focus is on developing products that improve the user experience for patients and providers by easing administration, enhancing safety profiles, or reducing waste. The company also participates in 503B offerings to address critical nationwide shortages of sterile injectables. Revenue is generated through the sale of its proprietary and generic products and fees from its CDMO services.

The company's first FDA product commercial launch occurred in June 2012, and it began marketing products under its own label in 2015. Exela's manufacturing campus in North Carolina employs over 500 people and has been recognized for its contribution to the local economy of an economically disadvantaged county. Exela has received federal government grants to expand its domestic production capabilities for medical countermeasures, reinforcing its role in national public health preparedness.

Keywords: specialty pharmaceutical, injectable drugs, sterile manufacturing, ophthalmic products, contract development and manufacturing organization, CDMO, generic pharmaceuticals, proprietary drugs, 505(b)(2) pathway, Abbreviated New Drug Application, ANDA, Phanesh Koneru, pharmaceutical manufacturing, drug shortages, parenteral products, cGMP manufacturing, pharmaceutical formulation, drug development, FDA approved manufacturing, healthcare solutions, pharmaceutical services, North Carolina pharma, aseptic processing, lyophilization services, drug commercialization, pharmaceutical supply chain