Company gets FDA approval to produce drug at Monroe site
Glenmark Pharmaceuticals, a generic drug manufacturer in Union County, has won federal approval to start making an anti-malaria drug, a big boost for a company that has invested $100 million in its Monroe facility over the last few years.
The company received approval June 18 from the U.S. Food & Drug Administration to begin commercial production of the drug at its 102,000-square-foot facility in Monroe, about 40 minutes outside of Charlotte.
Robert Matsuk, who heads Glenmark’s North American operations, called the FDA approval “the final result of all (our) work and effort.”
Prior to the approval, activity at the plant consisted mostly of preparing the facility for FDA inspection, as well as hiring and training new employees. The company employs about 130 people at the Monroe facility.
Now, Glenmark wants to expand its operations and clinical portfolio. The company also plans to manufacture more complex drugs at the Monroe site, which would require further FDA approval. The company will also add jobs, although Matsuk said he doesn’t have a number in mind.
“For us, it’s really only the start” Matsuk said.
Based in Mumbai, India, Glenmark has 17 manufacturing sites around the globe, with the Monroe plant its lone facility in the United States. The company already manufactures their anti-malaria drug in India, but needed FDA approval before it could manufacture it in the United States.
When the company came to Union County in 2015, it was the first pharmaceutical firm to operate out of the area in 20 years.
For Matsuk, the FDA approval process took longer than he had hoped. “For us, faster is always better,” Matsuk said.
When Glenmark develops other manufacturing locations in the U.S., it will look to this approval process as a template, Matsuk said.
Matsuk said the Monroe facility is a testament to Glenmark’s commitment to U.S.-based manufacturing.
“We’re bringing more affordable medicine to people … by producing these products in the U.S.,” he said. “This has been a long-term commitment of the company to grow and expand its footprint.”
Chris Platé, executive director of economic development of MonroeUnion County Economic Development, said Glenmark was offered about $500,000 worth of incentives from Union County.
“The payoff (from the incentives) is occurring now,” Platé said.
Platé hopes Glenmark’s success will attract more pharmaceutical companies to Union County. The area is currently dominated by the aerospace industry – 19 such companies are in a 7-mile radius.
Pharmaceutical firms bring high-paying jobs and large investments to the area, Platé said. “We’re just really excited about the future.”
Glenmark Pharmaceuticals, a Mumbai, India-based drug maker with 17 manufacturing facilities across the globe, has just received the FDA go-ahead for making a generic anti-malaria drug at its facility in Monroe.