Mayne Pharma Group, a branded and generic pharmaceuticals company, opened new $80-million, oral solid-dose commercial manufacturing facility in Greenville, North Carolina, USA.
Custom-designed from the ground up and under construction for two years, Mayne Pharma’s new leverages best-in-class containment design to meet or exceed the quality and safety standards of major drug regulatory authorities. The new facility more than quadruples the company’s capacity to manufacture oral solid-dose pharmaceutical products to well over 1 billion doses, and introduces significant capacity to manufacture potent compounds and new capability to manufacture modified-release bead/pellet products.
With this new facility, Mayne Pharma introduces commercial-scale, solvent-capable, fluid-bed processing and film coating. 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.
The facility enables Metrics Contract Services – Mayne Pharma’s contract development division – to offer clients a comprehensive “concept to commercialization” solution under one FDA site registration. Metrics Contract Services provides formulation development and analytical chemistry testing services to more than 100 third-party clients.