Mayne Pharma Group Limited announced its new US$80million, oral solid-dose commercial manufacturing facility in Greenville, North Carolina, USA, is officially open. Custom-designed from the ground up and under construction for two years, Mayne Pharma’s new 11,700 square metre (126,000 square foot) facility leverages bestin-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 in the US to well over 1 billion doses and introduces significant capacity to manufacture potent compounds and new capability to manufacture modified-release bead/pellet products.
Mayne Pharma’s CEO Scott Richards said, “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. The new plant will enable us to better control our supply chain, serve our customers better and reduce product costs. Over 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.”
“Mayne Pharma has a proven track record of success with technology transfers and product launches. This year, Mayne Pharma completed the technology transfer of disopyramide capsules from a Teva site to Greenville and launched two new products manufactured at Greenville — amiodarone tablets and doxycycline hyclate immediate-release capsules.”
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. Using this advanced drug-delivery technology, scientists can modify how a drug is released after ingestion, such as delaying or sustaining the 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 pharma companies today as they develop increasingly complex drugs for the treatment of cancer and chronic diseases. Each of the 13 production suites in the new facility was engineered to meet today’s stringent manufacturing demands with a best-in-class approach to mitigating cross contamination — while also offering flexible space and delivering a broad range of capabilities and services.
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