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First Product Will Be IV Bottles To Meet FDA Drug Shortage

WEST COLUMBIA, S.C., – Nephron Pharmaceuticals Corporation proudly announces a significant investment in its manufacturing capabilities with the launch of a new Rommelag Blow-Fill-Seal (BFS) production line. This new line, a $10 million expansion, adds a new presentation, BFS IV bottles, to the existing BFS lineup—respiratory ampules, injection vials, and ophthalmics—that Nephron offers. This will allow medications previously filled in traditional IV bags to be produced more efficiently, reducing wait times and costs. 

Capabilities will initially include 250mL IV bottles, with capacity up to 2,000 mL possible. The first production lots on the new line will be allocated to Nephron 503B Outsourcing Facility as it works tirelessly to fill FDA drug shortage needs.        

“The launch of our new BFS IV Bottle line is the latest embodiment of the Transformation, Execution, and Trust that drives our Quality First Culture,” said Lou Kennedy, CEO and Owner of Nephron. “We transformed our world-class manufacturing facility once again, investing in new manufacturing capacity on the latest German-engineered Rommelag BFS machinery. Our teams, from vendor auditors to engineers to quality assurance, executed this project with precision and dedication. Because at the end of the day we know that our relationships with customers, and ultimately patients, are built on trust.”

The first product being manufactured on the new line is Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP 2500 mcg/250 mL (10 mcg/mL*). This introduction comes at a crucial time, providing healthcare providers with a reliable source of essential medications amidst ongoing shortages. It is now available for order directly from Nephron for registered customers on the ordering portal. To set up an account for your facility, or to place an order for this product, please contact Nephron at 1-800-443-4313.

About Nephron Pharmaceuticals Corporation: A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division, which produces pre-filled sterile syringes, luer-lock vials, IV bottles, and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. For more information, please visit www.nephronpharm.com.

Contact: Nephron Pharmaceuticals Corporation customerservice@nephronpharm.com 1-800-443-4313

West Columbia, SC, June 26, 2024 – Nephron Pharmaceuticals Corporation is proud to announce its inclusion in the prestigious 2024 RXinsider Pharmacy500 list, an accolade recognizing the top 500 supply chain companies that have significantly impacted the U.S. dispensing pharmacy landscape.

“We are honored to be recognized by RXinsider for our contributions to the pharmaceutical industry,” said Lou Kennedy, CEO of Nephron Pharmaceuticals. “This acknowledgment underscores our commitment to a quality first culture marked by transformation, execution, and trust.”

Since launching its first inhalation product in 1997, Nephron Pharmaceuticals has grown into one of the largest blow-fill-seal (BFS) manufacturers in the world, producing respiratory, injection, and ophthalmic medications. The company has expanded its capabilities to include 503B outsourcing services, providing critical product to hospitals and surgery centers across the nation. Nephron maintains the same rigorous quality standards across both divisions, which are housed under one roof in its 840,000 square foot cGMP facility in West Columbia, South Carolina.

Nephron Pharmaceuticals is committed to addressing drug shortages and providing high-quality medications to patients. The company’s inclusion in the Pharmacy500 list is a testament to its ongoing efforts to support the pharmacy community and improve healthcare outcomes.

For more information about Nephron Pharmaceuticals and its products, please visit www.nephronpharm.com.

About Nephron Pharmaceuticals Corporation: Founded in 1997, Nephron Pharmaceuticals Corporation is a leading manufacturer of generic inhalation solutions and suspension products. The company is headquartered in West Columbia, SC, and is dedicated to improving patient access to affordable, high-quality medications. Nephron also provides 503B outsourcing services to ensure the availability of critical medications.

• No current FDA-approved formulation of ketamine for treatment of depression and suicidality
• Partners are developing a proprietary, tamper and diversion-resistant formulation and packaging
• Finished drug with two-year shelf stability targeted for November 2024, pending FDA approval
• Partners aim to submit New Drug Application by March 1, 2024

Radnor, PA. and West Columbia, South Carolina November 6, 2023 /PRNewswire/ – NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, (NRx), a clinical-stage biopharmaceutical company and Nephron Pharmaceuticals, Inc. (Nephron), a leading manufacturer of sterile injectable drugs today announced the signing of a development and manufacturing agreement to manufacture a presentation of ketamine suitable for treating suicidal depression, an urgent public health need. Recent CDC data suggest that more than 3 million Americans have active thoughts of suicide and more than 50,000 die from suicide each year.

Ketamine has increasingly been recognized as valuable for rapid reduction of suicidal thoughts as part of a comprehensive program of care and its use in depression has been endorsed as standard of care by both the US Department of Defense and the Veterans Administration. However, no manufactured presentation of ketamine with been submitted to or approved by the US FDA for this purpose and caregivers rely on ad hoc compounding of ketamine, a practice that has been the topic of recent FDA warnings.¹

“We at NRx are excited to partner with Lou Kennedy and her team at Nephron and to avail ourselves of Nephron’s decades of manufacturing excellence in developing a lifesaving product that has the potential to be available for patients by the end of 2024,” said Dr. Jonathan Javitt of Founder and Chief Scientist of NRx Pharmaceuticals. “We aim to combine Nephron’s history of producing highly-regarded FDA-inspected products with data from well-controlled clinical trials in seeking approval from FDA and regulators around the world.”

 

Submission of a New Drug Application for ketamine depends upon both the availability of data demonstrating safety and efficacy from well-controlled trials and upon the submission of data for a manufactured product demonstrating adherence to Good Manufacturing Practices and long-term stability, among other requirements. These requirements are intended to be met via the NRx/Nephron partnership.

“There are few efforts as important as playing a role – through research and development – in tackling the nation’s mental health crisis,” said Lou Kennedy CEO and owner of Nephron Pharmaceuticals. “To this end, we are honored to partner with NRx Pharmaceuticals in a groundbreaking endeavor. Together, we are advancing the production of single-dose, intravenous Ketamine, which could be a crucial breakthrough for the treatment of depression. Not only are we addressing an immediate demand, but we are also laying the foundation for a potential New Drug Application, signifying a significant leap forward in the improvement of mental health outcomes for patients.”

About NRx Pharmaceutical

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain.

NRx has recently announced plans to submit a New Drug Application for ketamine in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.

 

About Nephron Pharmaceuticals

A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable sterile pharmaceutical products in a state of the art GMP-compliant manufacturing facility. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes, luer-lock vials, IV bottles and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. For more information, please visit www.nephronpharm.com.

 

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company’s strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company’s management. Actual results could differ materially from those contemplated by the forward-looking statements. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, as may be supplemented, or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties, and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by these cautionary statements.

 

The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.

WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation today announced the new hiring of six key executives.

•  Laura Friendly, Chief Accounting Officer
•  Lori Aleshin, Head of Quality, Nephron 503B Outsourcing Facility
•  Scott Bobbitt, Site Head of Quality, Nephron Pharmaceuticals
• Mike Kimple, Vice President of Operational Excellence
• Eric Cochran, Senior Director of Quality Operations
• David O’Connell, Quality Operations Clean Room Senior Manager

“The industry knowledge and experience among this group is unmatched,” said Nephron CEO and Owner Lou Kennedy. “We could not be prouder that a group of this caliber is as excited as we are about the future of Nephron. They are committed to delivering life-saving medications to patients, and we are confident they are equipped with all the tools needed to build on our momentum and keep Nephron growing.”

Laura Friendly, Chief Accounting Officer 
Laura Friendly is a certified public accountant with over 20 years of financial and strategic analysis experience. Before joining the Nephron team, Friendly was the Vice President of Finance at MPZ Holdings, LLC, where she led the accounting department responsible for the financial operation of over 40 Marco’s Pizza locations. She has served as Chief Financial Officer at AVANTech, LLC and the Engineering Design & Testing Corp. Friendly received her Master of Business Administration and Bachelor of Science in Accounting from the University of South Carolina.

Lori Aleshin, Head of Quality, 503B Outsourcing Facility 
Lori Aleshin has proven success in developing quality standards, policies, and procedures across pharmaceutical and medical device industries. Before her role as Head of Quality for Nephron 503B Outsourcing Facility, Aleshin worked as Director of Quality for Athenex Inc. Pharmaceuticals, where she directly managed senior quality managers, engineers and oversaw 30 indirect quality control and microbiology laboratories, as well as all quality assurance employees. She has served in director-level roles at Ivoclar Vivadent Inc., where she successfully obtained Medical Device Single Audit Program Certification on her first application, and Safetec of America Inc. Aleshin earned her Master of Public Administration in healthcare management from Keller Graduate School of Management, her Master of Business Administration in Finance from Keller Graduate School of Management and her Bachelor of Science in Chemistry from Southern Arkansas University.

Scott Bobbitt, Site Head of Quality, Nephron Pharmaceuticals 
Scott Bobbitt brings to Nephron a comprehensive background in quality assurance management in the areas of R&D and commercialization for the pharmaceutical industry. Before joining the Nephron team, Bobbit served as vice president of quality for Adicet Bio Inc., where he was responsible for assuring the quality and compliance of cell, gene and CAR-T manufacturing, testing and distribution practices. Throughout his 30-year career, he has held key roles in quality assurance at organizations including Hitachi Chemicals Advanced Therapeutics Solutions, Dermira, Inc. and Novartis Pharmaceuticals Corporation. Bobbit earned his Bachelor of Science in Business Administration from North Carolina Wesleyan College and is currently pursuing a Master of Science in Quality Assurance at Southern Polytechnic State University.

Mike Kimple, Vice President of Operational Excellence 
During his nearly 30-year career, Mike Kimple has been responsible for the development, construction, operation and maintenance of the major multinational personal protective equipment (PPE) corporation, The Showa Group. As Americas Director of Manufacturing, he supervised the efforts of more than 700 employees for the operation, maintenance and expansion of three ISO-certified facilities. He held multiple management roles at the PPE manufacturer, where he oversaw the architectural design of its research and development center. Kimple received his Bachelor of Science in Biomedical Engineering from Vanderbilt University.

Eric Cochran, Senior Director of Quality Operations 
Eric Cochran joins Nephron with 25 years of manufacturing and quality assurance experience in biopharmaceutical and medical device environments producing sterile and non-sterile products. In his previous role as Senior Director of Manufacturing Quality Assurance at Glenmark Pharmaceuticals, he led a team of 14 responsible for all aspects of quality assurance and acted as an in-process quality assurance expert for the microbiology and chemistry laboratory activities, including all current Good Manufacturing Practices (cGMP). Cochran earned his Bachelor of Science in Chemical Engineering from Iowa State University.

David O’Connell, Quality Operations Clean Room Senior Manager
David O’Connell is a microbiology professional who has successfully recruited, managed, and led comprehensive environmental monitoring training for production personnel on aseptic techniques, behaviors, set-up, and equipment operation. Before joining the Nephron team, he served as a consultant for Pfizer at its McPherson, Kansas location, where he used MODA systems to improve the efficiency of daily operations. O’Connell has used his MODA expertise to train employees and implement its workflows at Charles River Laboratories and PCT Cell Therapy Services, developing teams with quality control best practices. O’Connell received his Associate Degree in Criminal Justice from Union College.

A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes, luer-lock vials, IV bottles and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. For more information, please visit www.nephronpharm.com.

WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation welcomed Morgan Nichols Scarnecchia as its Chief of Staff. In her new role, Scarnecchia will implement strategic business initiatives, manage daily operations and work alongside CEO, Lou Kennedy, in internal and external affairs.

“As two women who grew up in Lexington, Morgan and I not only share a great passion for the life sciences, but also South Carolina and the Midlands,” said Nephron CEO and Owner Lou Kennedy. “She is a great addition to our strong female leadership here at Nephron – and by working together, we will continue to drive Nephron forward.”

Before joining the Nephron team, Scarnecchia was the Director of Corporate Affairs for KOR Medical, where she built and managed the start-up’s key corporate accounts and communications for its various entities.

Scarnecchia has served as Corporate Affairs and Investor Relations Manager at SCbio, where she was responsible for board and investor communications and leading life sciences workforce initiatives like the association’s K-12 education programs. She began her career at the biotechnology organization as its Membership and Marketing Coordinator, recruiting life science companies and implementing new stakeholder engagement strategies.

In 2019, Scarnecchia was crowned Miss South Carolina. During her reign, she traveled across South Carolina promoting Stronger With STEM, a personal initiative created to promote a 21^st century workforce in the areas of science, technology, engineering and mathematics.

Scarnecchia received a Bachelor of Science in Genetics from Clemson University and is currently pursuing her Master of Biotechnology and Business from Johns Hopkins University.

A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes, luer-lock vials, IV bottles and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. For more information, please visit www.nephronpharm.com.

 

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WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation today announced Julie Rameas as Chief Procurement Officer. In her new role, Rameas will oversee all strategic sourcing and procurement activities.

“We could not be more excited to welcome Julie to the team. Her rock star resume and body of work speaks for itself,” said Nephron CEO and Owner Lou Kennedy. “From leading manufacturers to global success to blazing trails in textiles, Julie is precisely the kind of professional, who will help lead the continued growth and expansion of our company, and that is a great thing for those who depend on Nephron for life-saving medications.”

Rameas is an experienced professional with proven success in the pharmaceutical, medical device, metal, electronic, aerospace, automotive, and textile manufacturing industries.

Before joining the Nephron team, Rameas served as Senior Director of Global Strategic Procurement at Thermo Fisher Scientific, where she led spending activities for over 800 global sites, and managed multiple global expansion and construction projects.

She has held key global director roles at Lear Corporation, managing all aspects of global strategic procurement activity for seven manufacturing sites, and BioMerieux, where she led spending on all chemicals, biologics and controlled substances.

Rameas received her Bachelor of Science in chemistry from Indiana University of Pennsylvania.

A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes, luer-lock vials, IV bottles and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. For more information, please visit www.nephronpharm.com.

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WEST COLUMBIA, S.C. – Nephron 503B Outsourcing Facility, a division of Nephron Pharmaceuticals Corporation, is focused on resolving drug shortage concerns with the production of 0.5% Albuterol 5 mL, del Nido Cardioplegia, Lidocaine 1% and Succinylcholine products.

The following medications are readily available for order through the Nephron online ordering portal:

– 0.5% Albuterol 25 mg/5 mL (5 mg/mL) Preservative Free

– del Nido Cardioplegia Solution 1000 mL

– Lidocaine Injection Vial, USP 1% 50 mg/5 mL (10 mg/mL) Preservative Free

– Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL) Preservative Free

“As a nationwide leader in manufacturing lifesaving medication, we work hard every single day to help the federal government alleviate drug shortages – and to deliver hospitals and patients the treatments they deserve and expect in a timely manner,” said Lou Kennedy, CEO and Owner of Nephron. “Playing this vital role in manufacturing is all the motivation we need to do our jobs well – and stay focused on precisely what it takes to raise the bar not only for our team, but for manufacturers everywhere.”

Nephron has over 25 years of sterile pharmaceutical manufacturing experience and operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes, luer-lock vials, IV bottles and IV bags for hospitals across America.

To place an order, customers can contact Nephron directly at NOFaccounts@nephronpharm.com or 1-844-224-2225.

WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation today announced Christopher Fortier, PharmD, FASHP, CPEL, will join as President of its 503B Outsourcing Facility.

In his new role, Fortier will oversee all operations at the industry-leading facility that produces sterile medications for hospitals and medical facilities across America in an effort to alleviate their drug shortage needs.

“Chris has not only the education and skill, but also the knowledge of what major hospitals and pharmacies around the country need every day,” said Nephron CEO and Owner Lou Kennedy. “That combination will be an invaluable asset to the Nephron team.”

Prior to joining Nephron, Fortier was the Chief Pharmacy Officer at Massachusetts General Hospital in Boston. He was responsible for leading all aspects of Mass General’s pharmacy enterprise. He chaired the Mass General Brigham Chief Pharmacy Officer’s Council and was responsible for leading large-scale pharmacy initiatives at the health system level. 

Fortier has served in healthcare leadership roles for numerous state and national professional organizations, has been published in multiple healthcare journals, and has been featured in a variety of media outlets including NBC Nightly News, the Associated Press, the Wall Street Journal, National Public Radio, Bloomberg, and the Washington Post.

Fortier received his Doctor of Pharmacy from the University of Connecticut and completed a PGY-1/PGY-2 Health-System Pharmacy Administration Residency at the Medical University of South Carolina Medical Center in Charleston. He has given over 100 national and international presentations, is a course coordinator at Harvard Medical School, and has academic appointments at the University of North Carolina – Chapel Hill, the University of Connecticut, and Northeastern University. Fortier is a Fellow of the American Society of Health System Pharmacists (ASHP) and has also been certified as a Pharmacy Executive Leader by ASHP. 

Fortier serves as chair of the University of Connecticut School of Pharmacy Board of Directors and vice chair of United Way of Greater New Bedford Board of Directors.

A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes, luer-lock vials, IV bottles and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. For more information, please visit www.nephronpharm.com.

 

WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation today announced that preservative-free 0.5% Albuterol Sulfate Inhalation Solution is available now in a 25 mg/5 mL pre-filled vial. 

Nephron received FDA approval for Albuterol 0.5% 0.5 mL in 2001 and now provides millions of doses per year to patients nationwide.

In addition to Albuterol 0.5% 0.5 mL produced by Nephron, Nephron 503B Outsourcing Facility is now offering a larger fill volume of this essential product directly to hospitals and medical facilities, in an effort to alleviate the nationwide shortage. 

“Patients, families and healthcare providers should never worry about access to life-saving medication, and here at Nephron, making sure they have what they need is precisely what keeps us motivated,” said Lou Kennedy, CEO and Owner of Nephron. “As we continue to keep the needs of patients and families a top priority, they can count on us – and that makes us proud.” 

The 5 mL concentrated vial is available for use with continuous nebulization for adults and pediatric patients. This new, easy-to-dispense fill volume will save respiratory therapists valuable time and resources during patient care.

To place an order, customers can contact Nephron directly at NOFaccounts@nephronpharm.com or 1-844-224-2225.

A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes, luer-lock vials, IV bottles and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. For more information, please visit www.nephronpharm.com.