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WLTX News 19: Nephron Pharmaceuticals seeking FDA approval to ramp up production

March 17, 2020

COLUMBIA, S.C. — Nephron Pharmaceuticals is seeking FDA approval to ramp up production of medicines used in the treatment of coronavirus or COVID-19.

Lou Kennedy, president, CEO and co-owner of the West Columbia-based company, said that she had been in talks with the federal agency since December about bringing one to six new lines on production. The machines are some that Kennedy had moved from Nephron's former site in Florida and had already undergone FDA approval for operation at that site.

Kennedy said that in talks, the FDA and Nephron had scheduled to meet about the additional production lines on March 28 but since the coronavirus outbreak, approval could come as soon as the end of this week.

Nephron is one of only two drug companies in the United States making the respiratory medications -- bronchial dilators such as albuterol, sodium chloride and ipratropium bromide inhalation solutions and budesonide inhalation suspensions, and the only manufacturer of Racemic Epinephrine.

According to Kennedy, the company has been producing 80 million doses of medication per month and has orders equal to 87 million doses since the first of March, an 48 percent increase in demand for the products. With increased production, Nephron would be capable of producing 100 million doses per month. 

The December talks with the FDA also included procurement of active pharmaceutical ingredients. Kennedy says that Nephron has enough products and reagents to meet the demand to produce the medicines used in fighting respiratory ailments such as COVID-19.

The company has already started hiring and training personnel -- Kennedy says there are 1200 full-time and 100 apprentice employees and 860 part time educators.

In addition to the added production lines, the company will begin to manufacture hand sanitizing solution using the FDA approved recipe. Kennedy said that after making enough of the solution to service Nephron's needs, the company will look to needs in the community, specifically churches and charitable organizations for distribution.

Nephron has also installed an onsite child care facility that will be open 8am to 5pm.

The entire story is available here.