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Lou Kennedy Donates Nephron-Made Hand Sanitizer to Dorn VA Hospital

WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation CEO and Owner Lou Kennedy today donated fifty liters of hand sanitizer manufactured by the West Columbia company to the William Jennings Bryan Dorn VA Medical Center.

Kennedy announced earlier this week that the Food and Drug Administration had approved Nephron to produce hand sanitizer in the wake of the COVID19 pandemic.

“Our veterans and their families have sacrificed for us, and we could not be prouder to lend them a hand during this difficult time,” said Kennedy. “Americans are being challenged. We are coming together. I hope this spirit of community endures long after COVID19 passes.” 

Nephron Pharmaceuticals Corporation develops and manufactures safe, affordable generic inhalation solutions and suspension products that can be used to treat symptoms of COVID19. In addition, the company operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. 

“Nephron employees are on the front lines of the response to COVID19,” said Kennedy. “They are standing shoulder to shoulder with health care professionals, and we are going to keep working around the clock to deliver life-saving respiratory medications across the country.” 
 

IN CASE YOU MISSED IT: As Demand Surges, Nephron Prepared to Meet America’s Needs for Respiratory Meds

Current Demand for Nephron Medications is Surging: “Nephron Pharmaceuticals Corporation in West Columbia is one of the nation’s two top makers of these treatments. Nephron says current demand for its medications is surging and the company is shattering sales records. Nephron makes inhalation solutions and suspension products that treat respiratory conditions. ‘We make sure to be very rock solid in our preparation to accommodate the needs of America…’” (FOX Carolina, 3/17/2020)
 
Nephron Can Produce 100 Million Doses/Month. Already Has Orders for 87 Million Doses for March: “Nephron Pharmaceuticals can produce about 100 million doses of its respiratory nebulizer solution a month. But in the first half of March it already has orders for 87 million doses.” (South Carolina Public Radio, 3/17/2020)
 
“Rock Solid In Our Preparation to Accommodate the Needs of America”: “A West Columbia pharmaceutical company is looking to expand its production as orders spike for treatments used to combat respiratory illnesses, including COVID-19, which is caused by the novel coronavirus. …The company has the inventory to handle orders, but wants to make sure it could to meet demands if needs continue to grow. …Nephron Pharmaceuticals Corporation usually produces about 85 million doses a month of inhalation solution used in nebulizers used to treat respiratory issues. Lou Kennedy, the CEO of the company said the company eight product lines are operating 24 hours a day year round. But just halfway through March, Kennedy said Nephron has orders for 87 million doses, running 48% higher than normal. … ‘We make sure to be very rock solid in our preparation to accommodate the needs of America,’ Kennedy said. (The State, 3/18/2020)
 
Nephron Pharmaceuticals – 1 of 2 Companies Making Respiratory Meds – Seeking FDA Approval to Ramp Up Production: 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. 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. (WLTX News 19, 3/17/2020)
 
FDA Approves Nephron To Make Hand Sanitizer: During a conference call Tuesday, Kennedy also said Nephron has received FDA approval to begin making its own hand sanitizer and ordered supplies to do so on Monday. “We will take care of the Nephron family first, and after we do that, we will look at should we go through churches, the Salvation Army, how can we help the community, and/or commercial production,” she said. “I’ve had at least six requests from various sales reps across the country. Hospitals are asking can we make that hand sanitizer for them.” The plan is to produce 50-liter batches of a strong, FDA recipe without fragrances or other diluting agents, Kennedy said. She said she will gift what is left over from the first batch, after Nephron employees and their families have been served, to local charities. (Columbia Business Report, 3/17/2020)
 
Opens Childcare for Employees: “Nephron has also opened a childcare facility from 8 a.m. to 5 p.m. to help employees with their children, as schools have been closed around the state.” (The State, 3/18/2020)
 

The State: As demand for respiratory treatment spikes from coronavirus, SC company seeks expansion

A West Columbia pharmaceutical company is looking to expand its production as orders spike for treatments used to combat respiratory illnesses, including COVID-19, which is caused by the novel coronavirus.

Americans, whether they know it, may be reliant on the company because Nephron, and the Columbia-based the Ritedose Corporation, produce about 98% of the inhalation solution used in the country, Nephron CEO Lou Kennedy said.

As of Tuesday afternoon, South Carolina has seen at least 47 cases of the coronavirus, an infection known to affect people with respiratory issues worse than others. There have been more than 5,500 cases across the country, leading to more than 100 deaths.

Nephron Pharmaceuticals Corporation usually produces about 85 million doses a month of inhalation solution used in nebulizers used to treat respiratory issues. Lou Kennedy, the CEO of the company said the company eight product lines are operating 24 hours a day year round.

But just halfway through March, Kennedy said Nephron has orders for 87 million doses, running 48% higher than normal.

Since the beginning of the year, the company has been in contact with the FDA to seek approval to operate its six additional product and ramp up production to better supply hospitals, pharmacies, home care companies and long-term care facilities. It’s unclear if that will happen or when.

A meeting with the federal agency is scheduled for later this month to discuss next steps, Kennedy said.

The company is capable of producing 110 million doses a month, but wants to be able to increase its capacity by 50 million to 60 million doses, Kennedy said. They have enough people to ramp up production, with its roughly 2,000 full and part-time employees.

The company has the inventory to handle orders, but wants to make sure it could to meet demands if needs continue to grow.

“We make sure to be very rock solid in our preparation to accommodate the needs of America,” Kennedy said.

Nephron has also opened a childcare facility from 8 a.m. to 5 p.m. to help employees with their children, as schools have been closed around the state.

Columbia Business Report: Nephron requests approval to add production lines, will begin making hand sanitizer

In response to the novel coronavirus pandemic, West Columbia-based Nephron Pharmaceuticals Corp. has asked the Food and Drug Administration for permission to add up to six filling lines to ramp up its production of sterile respiratory medication.

Nephron CEO Lou Kennedy said she spoke with the FDA on Tuesday morning and is “waiting to hear back.” Kennedy also said Nephron will begin making its own hand sanitizer as early as this week.

Nephron, which CEO Lou Kennedy said is one of two companies in the U.S. that produce 98% of the nebulizer solutions used in hospitals or sold in retail outlets, relocated to South Carolina from Florida in 2014.

“We didn’t move all the equipment right away,” moving an additional six filling lines to South Carolina in 2019, Kennedy said. She said she had been in discussion with the FDA for permission to bring those machines online. A meeting had been scheduled for March 22 before she made another request Tuesday.

The eight filling lines currently being used in production of the inhalation solutions Nephron makes typically produce 80 to 85 million doses a month “on a regular basis” and are capable of making up to 110 million monthly doses, Kennedy said.

“As of yesterday, we had orders on the books for 87 million, so already a month’s worth,” Kennedy said. “For the last two weeks, those orders have been running about 48% higher than we would normally see. … We do have backstock that we’ve built up in inventory, (but) that won’t last forever.”

To maximize Nephron’s 24-hour, seven-day-a-week production schedule, Kennedy said the company has begun providing in-house child care. Children are provided food, and already stringent cleaning efforts have been “tripled,” Kennedy said. She said the same methods used to maintain sterile facility conditions, including the use of a fogging machine and wiping down surfaces with isopropyl alcohol and hydrogen peroxide, are being deployed in the day care.

“We’re really good at cleaning here, because we only make sterile drugs,” Kennedy said. “I’m very confident about making a clean environment for these children.”

During a conference call Tuesday, Kennedy also said Nephron has received FDA approval to begin making its own hand sanitizer and ordered supplies to do so on Monday.

“We will take care of the Nephron family first, and after we do that, we will look at should we go through churches, the Salvation Army, how can we help the community, and/or commercial production,” she said. “I’ve had at least six requests from various sales reps across the country. Hospitals are asking can we make that hand sanitizer for them.”

The plan is to produce 50-liter batches of a strong, FDA recipe without fragrances or other diluting agents, Kennedy said. She said she will gift what is left over from the first batch, after Nephron employees and their families have been served, to local charities.  

Kennedy said as early as December, Nephron began taking stock of things such as the resin used to make vials of its liquid medication as well as its supply of active pharmaceutical ingredients. “We are fortunate that we have more than a year’s supply of that (API) on hand,” she said.

Nephron makes bronchodilators including albuterol used to treat respiratory illnesses such as bronchial asthma, pneumonia, emphysema and croup. It also manufactures Pocket Nebs, which are portable, battery-charged nebulizers.

Novel coronavirus can cause cough, shortness of breath and breathing difficulties. Severe infections can lead to complications including pneumonia, according to the World Health Organization.

Increased product demand during cold, cough and allergy season, as well as past experience with respiratory illnesses including SARS and H1N1, have made the company ever-vigilant, Kennedy said.

“We make sure to be very rock-solid in our preparation to accommodate the needs of America,” she said.

Kennedy said hiring and training has already begun in anticipation of FDA approval of the additional filling lines.

“We have the people to be able to ramp that up right now,” she said. “ … If we don’t get our hands wrapped around this quickly, meaning we squelch the spread, get control of the spread, it’s going to be a long, hard road. But it’s easily solved if the FDA allows me to ramp up the five or six other lines that I brought here from Florida.”

Reach Melinda Waldrop at 803-726-7542.
 

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

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.
 

FOX Carolina: SC company producing respiratory solutions to help treat coronavirus

COLUMBIA, SC (FOX Carolina) – A South Carolina pharmaceutical company is working to ramp up production of respiratory solutions to treat symptoms of COVID19

Nephron Pharmaceuticals Corporation in West Columbia is one of the nation’s two top makers of these treatments. Nephron says current demand for its medications is surging and the company is shattering sales records.

Nephron makes inhalation solutions and suspension products that treat respiratory conditions.

During a media advisory Tuesday, Nephron CEO Lou Kennedy told reporters that COVID19 patients need treatment immediately that that goes way down into the lungs.

Only 2 companies in the U-S make 98 percent of those nebulizers and Kennedy said his is working to ramp up Nephron’s production.

Right now Nephron’s 8 filling lines are able to produce about 110-million inhalers each month.

In order to ramp that up to about 170-million a month, Kennedy is asking the FDA to allow Nephron to open 6 more filling lines to produce more “inhalation solutions.”
 

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