Pharmaceutical company Mayne Pharma has announced launching an $80-million, oral solid-dose commercial manufacturing facility in Greenville, North Carolina.
Mayne Pharma’s new 126,000-square-foot (11,700 square-meter) facility more than quadruples the company’s capacity to manufacture oral solid-dose pharmaceutical products in the United States to over one billion doses.
The new facility also introduces significant capacity to manufacture potent compounds and new capability to manufacture modified-release bead/pellet products.
“This new Greenville facility will greatly enhance our internal capacity and capability to support the mid- to long-term growth potential we see for our business and allows us to manufacture in the United States advanced drug-delivery technologies that until today were only available in our Australian facility,” Mayne Pharma’s CEO Scott Richards said.
“The new plant will enable us to better control our supply chain, serve our customers better and reduce product costs. In the next few years, Mayne Pharma expects to introduce more than 20 products and double its manufacturing volumes in the Greenville site, driven by the pipeline of products under development, the transfer in-house of several products currently manufactured by third parties, and by providing our Metrics Contract Services clients with commercial contract manufacturing services,” he said.
With this new facility, Mayne Pharma introduces commercial-scale, solvent-capable, fluid-bed processing and film coating — a first for its operations in the United States. Fluid-bed processing (also called multi-particulate or bead coating) applies polymers to an active pharmaceutical ingredient (API). Using this advanced drug-delivery technology, scientists can modify how a drug is released after ingestion, such as delaying or sustaining its release to reduce side effects or make the drug more effective.
Specifically designed for containment, the new facility can readily manage the commercial-scale manufacturing of potent compounds — a key growth area for pharmaceutical companies today as they develop increasingly complex drugs for the treatment of cancer and chronic diseases.