New Jersey stands at the center of the nation's pharmaceutical industry. Often called the "Medicine Chest of the World," the state is home to the headquarters or major operations of many of the world's largest pharmaceutical companies. For hospitals, clinics, and health systems across the Garden State and throughout the Northeast, 503B outsourcing facilities provide a critical supply of sterile and non-sterile compounded drugs produced under FDA oversight and Current Good Manufacturing Practices (cGMP).
This page provides a comprehensive, up-to-date directory of all FDA-registered 503B outsourcing facilities located in New Jersey. Each facility listed below is registered with the FDA and subject to federal inspection standards.
Official List of FDA-Registered 503B Facilities in New Jersey
Denver Solutions, LLC, dba Leiters Health
An FDA-registered 503B outsourcing facility located in Buena, in southern New Jersey's Atlantic County. Operating as Leiters Health, this facility has been registered with the FDA since July 2022 and provides sterile compounding services.
View Full Profile →Empower Clinic Services New Jersey
Located in East Windsor in central New Jersey's Mercer County, this facility is part of the Empower family of 503B outsourcing operations. FDA-registered since June 2024, it provides sterile compounding services to the greater New Jersey and Northeast healthcare market.
View Full Profile →Hikma Injectables USA Inc.
A non-sterile 503B outsourcing facility in Dayton, Middlesex County. Part of global pharmaceutical company Hikma Pharmaceuticals, this facility has been FDA-registered since September 2021. Form 483 issued during most recent inspection.
View Full Profile →Hikma Pharmaceuticals USA Inc.
Located in Cherry Hill, Camden County, this sterile compounding 503B facility is part of the Hikma Pharmaceuticals network. FDA-registered since September 2021. Form 483 issued and FMD-145 notice issued December 2024 following the most recent inspection.
View Full Profile →Hyalo Technologies Limited Liability Company
A newly registered 503B outsourcing facility in Somerset, Somerset County. FDA-registered since May 2025, offering sterile compounding services to the central New Jersey and greater Northeast healthcare market.
View Full Profile →Imprimis NJOF, LLC
One of the longest-operating 503B outsourcing facilities in New Jersey, Imprimis NJOF has been FDA-registered since November 2016. Located in Ledgewood, Morris County, it serves the northern New Jersey healthcare market. Form 483 issued during the most recent inspection.
View Full Profile →Molecular PharmaGroup
A sterile compounding 503B outsourcing facility in New Providence, Union County. FDA-registered since May 2018, Molecular PharmaGroup serves healthcare providers across the New York metropolitan area. Form 483 issued during most recent inspection.
View Full Profile →Quva Pharma, Inc.
A major 503B outsourcing facility in Bloomsbury, Hunterdon County. FDA-registered since September 2017, Quva Pharma is one of the longest-operating 503B facilities in New Jersey and one of the largest sterile compounding outsourcing facilities in the Northeast. Form 483 issued during most recent inspection.
View Full Profile →Sankav Pharmaceuticals, LLC
A newly registered 503B outsourcing facility in Hackettstown, Warren County. FDA-registered since March 2025, providing sterile compounding services to the northwestern New Jersey region.
View Full Profile →Stokes Healthcare Inc., dba Epicur Pharma
Operating as Epicur Pharma in Mt. Laurel, Burlington County. FDA-registered since January 2018, this facility serves the southern New Jersey and greater Philadelphia healthcare corridor. Form 483 issued during the most recent inspection.
View Full Profile →New Jersey: The Nation's Pharmaceutical Corridor
New Jersey has long been recognized as a global hub for pharmaceutical manufacturing and innovation. The state's strategic position along the I-95 corridor between New York City and Philadelphia, combined with its deep talent pool and robust infrastructure, has made it a natural home for pharmaceutical operations of all sizes. More than a dozen major pharmaceutical companies maintain headquarters or significant manufacturing operations in the state.
This concentration of pharmaceutical expertise extends to the 503B outsourcing sector. New Jersey's 10 FDA-registered 503B facilities benefit from the state's established pharmaceutical supply chain, specialized workforce, and proximity to some of the nation's most prestigious medical centers, including those in the New York City metropolitan area, the Philadelphia region, and the Princeton healthcare corridor.
Why Partner with a New Jersey-Based 503B Facility?
For hospitals, clinics, and health systems operating in New Jersey and the broader Northeast, sourcing compounded medications from an in-state 503B outsourcing facility offers several key advantages:
- Logistical Efficiency: Shorter shipping distances mean faster delivery times and reduced shipping costs, especially for temperature-sensitive sterile preparations that require cold-chain management. A facility in central New Jersey can typically deliver to hospitals across the Northeast corridor within one business day.
- Regional Expertise: New Jersey-based facilities understand the unique needs of the Northeast healthcare market, including the high-volume demands of major health systems in the New York-New Jersey-Philadelphia metropolitan region.
- Simplified Audits: Many healthcare systems conduct on-site vendor audits before adding a 503B facility to their approved supplier list. Partnering with a local facility makes these audits more practical and cost-effective, without requiring expensive out-of-state travel.
- Pharmaceutical Infrastructure: New Jersey's deep pharmaceutical industry roots mean local 503B facilities have access to an experienced workforce, established supply chains, and a regulatory environment that supports pharmaceutical manufacturing excellence.
Navigating Compounding Regulations in New Jersey
503B outsourcing facilities in New Jersey operate under a dual regulatory framework. At the federal level, they are overseen by the FDA and must comply with Current Good Manufacturing Practices (cGMP). At the state level, they must also maintain licensure and good standing with the New Jersey State Board of Pharmacy.
The New Jersey State Board of Pharmacy, under the Division of Consumer Affairs, oversees all pharmacy operations in the state, including licensing, inspections, and enforcement of state pharmacy laws. While the FDA is the primary regulatory authority for 503B facilities with respect to cGMP compliance and product quality, the Board ensures that these facilities also meet state-level requirements for pharmacy operations, pharmacist oversight, and record-keeping.
Healthcare providers in New Jersey should verify that any 503B facility they partner with is both FDA-registered and in good standing with the New Jersey State Board of Pharmacy. For more on the differences between federal and state oversight of compounding pharmacies, see our guide to 503A vs. 503B pharmacies.
Find a 503B Pharmacy Near You
Northern New Jersey 503B Facilities
Northern New Jersey, with its proximity to the New York City metropolitan area, is home to several FDA-registered 503B outsourcing facilities serving the densely populated tri-state region.
- Hyalo Technologies Limited Liability Company — Somerset
- Molecular PharmaGroup — New Providence
- Imprimis NJOF, LLC — Ledgewood
- Sankav Pharmaceuticals, LLC — Hackettstown
Central New Jersey 503B Facilities
Central New Jersey, including the Princeton corridor and Middlesex County, is home to 3 registered 503B outsourcing facilities, benefiting from the region's concentration of pharmaceutical companies and research institutions.
- Empower Clinic Services New Jersey — East Windsor
- Hikma Injectables USA Inc. — Dayton
- Quva Pharma, Inc. — Bloomsbury
Southern New Jersey 503B Facilities
Southern New Jersey, spanning the Philadelphia suburbs and the Atlantic County corridor, is served by 3 registered 503B outsourcing facilities providing coverage for the southern part of the state and the greater Philadelphia region.
- Hikma Pharmaceuticals USA Inc. — Cherry Hill
- Stokes Healthcare Inc., dba Epicur Pharma — Mt. Laurel
- Denver Solutions, LLC, dba Leiters Health — Buena
Your Trusted Source for 503B Information in New Jersey
View detailed profiles for each New Jersey-based facility, including FDA inspection histories, compliance status, and contact information. Or let us help you find the right compounding partner for your specific needs.
Browse All 503B FacilitiesNew to 503B outsourcing facilities? Read our comprehensive guide: What is a 503B Pharmacy? Or learn about the key differences between traditional compounding and outsourcing facilities in our 503A vs. 503B comparison guide.