Regulatory Pathways Leverage Exela’s focus on high-barrier injectable and sterile ophthalmic products developed via 505(b)(2) and ANDA pathways to position specialized outsourcing, regulatory support services, and accelerated product launch partnerships with contract manufacturers or CROs.

Recall & Safety Proactively offer quality assurance, post-market surveillance, and robust packaging/rework solutions to bolster safety and reduce recall risk, addressing a history of product recalls and particulate matter events.

Joint Ventures Explore co-development and co-manufacturing opportunities with Exela on ophthalmic injectables, leveraging their growing pipeline and manufacturing capabilities to expand market reach efficiently.

Geographic Expansion Target collaborations around manufacturing and distribution enhancements in the U.S. market, supported by Exela’s partnerships with CDMOs and EPCM firms to scale facilities in key regions such as North Carolina.

Affordability & Outcomes Position as a value-focused supplier offering affordable, high-quality injectable ophthalmics that reduce administration burden and waste, aligning with Exela’s mission to improve patient outcomes and lower healthcare costs.