GREENVILLE, N.C., Nov. 13, 2018 /PRNewswire/ — Metrics Contract Services (Metrics), a division of Mayne Pharma Group Limited, is pleased to announce successful qualification of two commercial bottling lines for serialization at its new US$80 million oral solid dose commercial manufacturing site in Greenville, North Carolina, USA. This marks the culmination of several years of preparation and investment to comply with the new requirements associated with the US Drug Supply Chain Security Act (DSCSA), which are subject to enforcement starting November 2018.
As part of the Greenville site expansion, packaging capacity has more than doubled. One bottling line is dedicated for clinical packaging, and two commercial bottling lines have been qualified for serialization. The newly installed equipment includes a New Jersey Machine with an IMA automated case packer and palletizer. The new commercial facility has space available to add a third commercial packaging line as needed to support future growth.
Mayne Pharma has implemented Optel systems on the packaging lines and is using TraceLink as its level 4 and 5 provider to manage the enterprise and network connectivity. Qualification of both commercial packaging lines includes aggregation capabilities in anticipation of the next regulation enforcement deadlines.
Metrics’ Executive Vice President Kimberly McClintock said, “We are pleased to provide serialized bottling services to our Metrics’ clients to complete our concept to commercialization offering. Our ability to offer testing, manufacturing, and packaging all at one site in North Carolina offers an efficient and convenient supply chain solution. While this is a new service offering for Metrics, the Greenville site has substantial firsthand experience supporting more than 30 Mayne Pharma products across 90 product SKUs through the serialization transition. Metrics’ clients have access to a seasoned team with direct experience ensuring successful serialization interactions with 3PLs, wholesalers and retailers.”
About Metrics Contract Services
Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide delivering proven scientific and operational excellence for oral dosage forms.
Metrics’ areas of expertise include quality pharmaceutical formulation development; first-time-in-man formulations; Phase I-III clinical trial materials manufacturing; and analytical method development and validation services leading to commercial scale manufacturing.
Technical capabilities include highly potent, cytotoxic and unstable compounds; Schedule II-V controlled substances; and products with poor bioequivalence, for which we offer an impressive proprietary portfolio of advanced delivery methods. Located in Greenville, N.C., Metrics is a proud member of Mayne Pharma. Learn more at www.metricscontractservices.com
About Mayne Pharma
Mayne Pharma is a specialty pharmaceutical company listed on the Australian Securities Exchange (ASX: MYX) focused on the application of drug delivery expertise to commercialize branded and generic pharmaceuticals, providing patients with access to better and more affordable medicines.
Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems, and these technologies have been successfully commercialized in numerous products that have been marketed around the world. Mayne Pharma has two drug development and manufacturing facilities based in in Salisbury, Australia and Greenville, USA, with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and inherently unstable compounds. For further information, visit www.maynepharma.com.