Mayne Pharma opens $80m facility, expands CDMO offering

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/SerrNovik)
(Image: Getty/SerrNovik)
Mayne Pharma has opened a new 126,000-square-foot oral solid-dose manufacturing facility to meet demand driven by new product launches – and new revenue stream from its CDMO business.

The new facility in Greenville, NC quadruples Mayne Pharma’s capacity to manufacture oral solid-dose pharmaceuticals in the US. Additionally – a first for the company’s US operations – Mayne Pharma can now provide commercial-scale, solvent-based, fluid-bed processing, and film coating. The addition triples its fluid-bed processing capacity globally, according to the company.

“The new facility was needed as we were reaching capacity in the current facility,”​ explained Lisa Pendlebury, vice president, investor relations and communications, Mayne Pharma.

The company’s other Greenville-based facility features 99,200 square feet of FDA-approved manufacturing space.

“The increased demand has been driven by new product launches, the new revenue stream from commercial contract manufacturing and the transfer in house of several products from the Teva portfolio acquisition that we completed in 2016,”​ she told us.

Now able to produce more than 1bn doses, the new facility also introduces capabilities to manufacture modified release bead/pellet products, said Pendlebury. The expansion also provides “significant capacity”​ to manufacture potent compounds.

Since announcing the expansion in August 2015, Pendlebury said the company’s Greenville workforce has increased by 98 and the total workforce in NC has increased by 160. Maybe Pharma also has offices in Raleigh, NC.

Contract development and manufacturing

According to the company, the new facility enables its contract development and manufacturing organization (CDMO), Metrics Contract Services, to offer its clients a “concept to commercialization”​ solution under one FDA site registration.

While not new to the Mayne Pharma team or the Greenville site, commercial manufacturing is a new offering for the company’s development clients. Due to space constraints, the CDMO was previously unable to “broadly”​ provide commercial manufacturing out of the Greenville facility, according to the company.

With commercial manufacturing now consolidated at the new facility, Mayne Pharma will repurpose its former manufacturing facility to expand pre-commercial product development capacity. The work will unfold over the next two years and will include the creation of more than 10 new processing rooms and expanded laboratories, according to the company, according to the company.

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