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After 16 long months, Nephron finally receives full FDA approval

Manufacturing
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By Chris Cox
ccox@scbiznews.com
Published Oct. 28, 2015

Sixteen long months have passed since Nephron Pharmaceuticals opened its new plant in Lexington County, and ever since it’s been a patient waiting game for Food and Drug Administration approval.

The company, which produces generic medications sold through major national retailers, first began ramping up operations last September. The Orlando, Fla.-based company, owned by South Carolina natives and USC graduates Bill and Lou Kennedy, has been stocking product since, unable to ship it out until getting the go-ahead from the FDA.

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An automated production line for the manufacturing of respiratory medication must be operated in a “clean room” at Nephron Pharmaceuticals’ new South Carolina plant. Workers in the clean room are required to wear sterile caps and gowns. (Photo/Chuck Crumbo)
And now they finally have it. The federal agency gave Nephron final approval last week, making it officially open for business after first opening its doors June 2014.

“I am beyond thrilled to have an approval letter and begin production in South Carolina,” Lou Kennedy said. “It is going to be an exciting year for Nephron, and we look forward to growing our product portfolio.”

Spokeswoman Grayson Posey said Nephron is currently ramping up production, and distribution began immediately upon receiving approval. The manufacturer anticipates having all eight of its production lines running at full capacity by the end of next summer, she said.

Nephron, which employs 186 people at the 408,000-square-foot green field facility in West Columbia, will continue operating its current line of generic respiratory products. Those include Duo Dose, a combination product of Albuterol Sulfate and Ipratropium Bromide, and Albuterol Sulfate. It also has three new drugs in the pipeline, Posey said, including an injectable which will be produced locally.

Nephron, which presently produces nearly 2 billion doses of medication a year, thought for a time that it might receive approval earlier this winter. Kennedy said at the time during the Columbia Regional Business Report’s quarterly “Power Breakfast” networking event that the FDA was expected to visit the company in the coming weeks.

The medication supplier had been handcuffed in generating revenue as it waited for the FDA to review its products, and such time is critical to the manufacturer. It sells drugs anywhere from 7 cents to $1.15, and it currently takes about three years to get a generic pharmaceutical review to market.

“It’s a waiting game, is the nicest way to put it,” Kennedy said at the time. “We’ve really been impeded in the sense that we can’t pick our own time clock, and we have to be very patient, and I guess you could say aggressive in terms of business.”

Thankfully for the Kennedys, that is no longer the case. Nephron is open for business.

“Finally, instead of a money drain,” Kennedy said in February,” we can potentially produce some revenue.”

Reach Chris Cox at 803-726-7545 or on Twitter @chrisbcox.

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