Com­pany gets FDA ap­proval to pro­duce drug at Mon­roe site

The Charlotte Observer (Sunday) - - News - BY HAN­NAH LANG [email protected]­lot­teob­

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.”

Photo courtesy of Glen­mark Phar­ma­ceu­ti­cals

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.

Robert Mat­suk

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