Glenmark Pharmaceuticals recently opened its new manufacturing site in Monroe, NC, which will serve as the company’s first manufacturing site in the U.S. The 100,000 sq.-ft. facility is among the largest pharmaceutical manufacturing sites in the Charlotte region and is designed to manufacture a variety of fixed dose pharmaceutical formulations.
 
Glenmark has invested more than $100 million in the facility with plans for further expansion in the coming years. At peak capacity, the site is anticipated to produce 300-400 million tablets and capsules, 20-25 million vials and pre-filled syringes, and 25-30 million ampoules for inhaled formulations. It’s also expected that the site will grow well beyond its current 168 employees.
 
We spoke with Robert Matsuk, president of North America at Glenmark Pharmaceuticals about the new site and the significance of establishing U.S. operations. –KB
 
Contract Pharma: What market trends are behind the opening of this facility?
 
Robert Matsuk: Glenmark is a global pharmaceutical company with operations in more than 50 countries. The U.S. market and political environment offers Glenmark an opportunity to bring tremendous value to the prescription drug market and patients.  In addition, the pro-business regulatory ecosystem and the educated workforce made the investment possible. We look forward to expanding our footprint in the United States significantly over the coming years. The U.S. and India are the two major geographies for Glenmark, contributing to 60 percent of all revenues. Our commercial business continues to thrive in the U.S. and our presence is growing at a strong rate.

CP: What manufacturing technology features will the new facility have?
 
RM: This new site is designed to manufacture a variety of fixed dose pharmaceutical formulations. As Glenmark further grows this facility, capabilities will continue to grow. Currently, at peak capacity, the site is anticipated to produce 300-400 million tablets and capsules, 20-25 million vials and pre-filled syringes and 25-30 million ampoules for inhaled formulations.
 
CP: What is the significance of the NC location for the company’s first U.S. facility?
 
RM: A combination of factors led to the location of the first U.S.-based Glenmark manufacturing facility in Monroe, NC – including a pro-business state that welcomed our presence, and a healthcare and workforce ecosystem that will enable Glenmark to not only become a greater part of the community, but a community that is prepared to help Glenmark achieve this growth. North Carolina offers tremendous support for the pharmaceutical industry and provides a number of incentives that make it an attractive place to do business. This goes far beyond traditional tax incentives and into areas that are critical to help businesses succeed such as the North Carolina BioNetwork that helps provide training programs through the community college system to help train and retain the workforce we need to be successful.
 
CP: Are there any specific challenges or hurdles establishing U.S. operations?
 
RM: Wherever you establish manufacturing operations globally, there are different, often complex, regulations that need to be followed and managed carefully. The Monroe, NC site, being the first manufacturing facility for Glenmark in the U.S., was no exception. Globally, Glenmark has 16 world class manufacturing facilities across four continents operating under Good Manufacturing Practices (GMP) to ensure quality and safety, nine of which are registered with the U.S. Food and Drug Administration. We benefited from this deep experience and established global presence to anticipate challenges and address them quickly while maintaining the highest levels of quality and compliance.

CP: What are the company’s further expansion plans?
 
RM: Glenmark has already invested over $100 million into the facility, and has plans for further expansion in the coming years. An additional 5 acres at the Monroe site has already been acquired for this future growth.