503B Outsourcing

503B Outsourcing with cGMP Quality

Nephron has over 20 years of sterile pharmaceutical manufacturing experience. Our cGMP compliant, 503B Outsourcing facility uses industry-leading technology to deliver sterile, high quality pharmaceutical products.

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Nephron 503B Outsourcing Facility is a division of Nephron Pharmaceuticals Corporation. This division produces pre-filled syringes and other sterile medications for hospitals and medical facilities across America in an effort to alleviate their drug shortage needs.

Registered customers can place their orders directly by logging into our 503B Outsourcing online ordering website. Upon processing, all orders are shipped UPS for next day delivery.

Visit our 503B Outsourcing Ordering Portal

Dedicated Quality Professionals

The Nephron team is dedicated to exceeding quality, regulatory, and validation standards. All products are produced on fully validated equipment and are verified with advanced in-house analytical, chemistry, and microbiological testing.

Nephron stands by its commitment to distribute only the highest quality medication, after all test results meet specification. It is our mission to deliver safe, quality products – day in and day out. We are licensed in all 50 states and regularly inspected by the FDA.

In accordance with the DQSA draft guidance, Nephron 503B Outsourcing follows cGMP, GDP and all quality expectations. Most importantly, the company only releases product after sterility, bacterial endotoxin, particulate matter, environmental monitoring, and all other release testing data is available and passing.

Dependable Service and Technology

Nephron 503B Outsourcing Facility is located within our industry leading manufacturing campus, so we can use our quality, regulatory, and validation resources for sterile drug compounding. Our outsourcing division is regularly inspected by the FDA and operates certified clean rooms using current Good Manufacturing practices (cGMP). We have invested in the latest technology advancements, so you can be confident in our process, service, logistics, and uninterrupted supply chain. We are positioned to help your health care facility succeed.

Quotation Marks Inside Speech Bubble

Nephron has been a bright spot during our struggles with drug shortages, and even fluid shortages, over the last several years. When we do have delays they are relatively short and communication about them is comprehensive and abundant. Nephron’s customer service can’t be beat, and they are often our first ask when we want to request a new compound.

Jon Brown PharmD, MHA System Manager-Pharmacy Sourcing, Nephron 503B Customer

We are a registered 503B outsourcing facility with certified clean rooms and two decades of experience complying with current Good Manufacturing Practice (cGMP).

We offer competitive prices so that you can rely on our experts and world-class facility, rather than worrying about compliance issues, staffing costs, and wasted product.

We have invested in rapid sterility equipment, enabling us to distribute compounded drugs as soon as five days after formulation. This is ideal, as our competitors can take several weeks.

Quality is our Top Priority

Nephron 503B Outsourcing has expanded capacity to help alleviate the nationwide shortage of life-saving, sterile medications across the US. Nephron officials recognize that persistent drug shortages pose a threat to the quality of patient care.

In an effort to address this ongoing crisis, Nephron has responded with 24-7 production of shortage products, including sterile small-volume parenteral solutions (SVPs) and pre-filled sterile syringes.

Nephron releases batches of products, only after all release data is available and passing.  Each and every batch of medication is fully tested and must pass strict parameters, or it will not be released into the market. The company stands by its commitment to distribute only the highest quality medication. 

We have over 20 years of experience manufacturing high quality, sterile medications. We devote the same careful attention to quality and safety in our approach to drug compounding.

Quality Assurance

Our team of experts ensure every substance that enters and exits our facility is safe for use. When active pharmaceutical ingredients arrive on site, our quality assurance department samples and reviews the ingredients before they are released for use. We perform another quality check after we formulate products, reviewing samples from each batch within our in-house chemistry and micro-biology laboratories before products are shipped to end users. 

Michael Parker

Human ingenuity and experience guides us forward. As Executive Vice President of Manufacturing Operations, Michael Parker leads our facility advancements. Michael’s 18 years of manufacturing experience in the plastics industry was invaluable as we designed our new facility to lead the world in BFS technology, which forms, fills, and seals vials without human interaction. The technology uses plastic vials rather than glass, which increases sterility, reduces risk of breakage, and simplifies use for the patient. The quality of our processes defines our business, and we are proud to have Michael driving us forward with BFS technology. 

Hospitals and surgery centers can contact the Nephron 503B Outsourcing Facility toll free at 1-844-224-2225 or email NOFaccounts@nephronpharm.com. Our sales advisors are available to assist you between the hours of 8AM and 8PM EST.