A pharmaceutical startup in the Ben Franklin Technology Partners of Northeast Pennsylvania Tech Ventures in Bethlehem is expanding. US Specialty Formulations LLC, a specialty pharmaceutical manufacturer, plans to add space and three new highly skilled positions to its staff. According to Ben Franklin, there is a great need for specialized and custom-manufactured drugs, and the existing infrastructure isn’t sufficient to support their manufacture, leaving them to be produced in pharmacies and other facilities that are inconsistent and less regulated.
As a U.S. Food and Drug Administration-registered outsourced manufacturer, US Specialty Formulations LLC bridges that gap to provide the proper environment for the production of those pharmaceuticals, the incubator said in a release. Kyle Y. Flanigan, CEO of US Specialty Formulations, said the outsourced facility needs to comply with the FDA’s 2014 Drug Supply Chain Security Act. Because of that, his company deliberately has been taking its time on its growth strategy, he said this morning.
“We started out at Ben Franklin to get our business model and regulatory model ironed out and aligned to what the FDA is requiring,” Flanigan said. “We’re further along on that path, so it’s time to expand.” Flanigan said the expansion will enable the company to take on larger contracts to make larger batches of materials. The company focuses on specialty sterile injectable drugs for humans and animals.Read More