New Era Global | 503B FDA-Registered Outsourcing Facility
FDA Registered Facility

The Evolution of Pharmaceutical Excellence

New Era Global 503B Pharmacy is an FDA-registered outsourcing facility based in San Juan, Puerto Rico, committed to advancing pharmaceutical quality, safety, and accessibility.

New Era Global Facility
503B
FDA Registered
cGMP
Certified
24/7
Quality Control
New Era Global Laboratory
100%
Quality Assured

Advancing Healthcare Through Science & Innovation

We specialize in the large-scale compounding of ready-to-use sterile medications for hospitals, surgical centers, clinics, and healthcare systems across Puerto Rico and the mainland United States.

Every formulation produced at New Era Global follows the strictest Current Good Manufacturing Practice (cGMP) standards set by the U.S. Food and Drug Administration, ensuring sterility, potency, and consistency in every batch.

FDA Registered

Full regulatory compliance

Sterile Production

ISO-classified cleanrooms

Third-Party Tested

Independent verification

Advanced Technology

Automated systems

Our Mission

To deliver high-quality, science-driven pharmaceutical solutions that enhance patient outcomes, ensure reliable access to essential medications, and strengthen healthcare resilience.

Through continuous research, innovation, and a steadfast commitment to regulatory integrity, New Era Global is setting a new standard for trusted 503B outsourcing—from Puerto Rico to the world.

50+
Healthcare Partners
100%
Batch Testing
24/7
Environmental Monitoring

What a 503B Outsourcing Facility Means for You

A 503B facility is authorized to compound large-batch, "office-use" medications for hospitals, clinics, and physician offices—without the need for a patient-specific prescription.

The FDA established this designation to raise the national standard for quality, safety, and consistency in compounded medications.

  • Validated production systems & environmental controls
  • Sterility assurance programs & quality documentation
  • Independent third-party laboratory testing
  • Same cGMP standards as pharmaceutical manufacturers
Learn More at FDA.gov
503B Facility

cGMP Certified

Built from the ground up for full 503B compliance and FDA standards.

Healthcare Provider
Trusted by Healthcare Leaders

Partner with Excellence in Compounding

Providers choose New Era as their compounding pharmacy of choice because they are confident in the quality of our medications and appreciate the personalized service we provide.

Through custom compounding, we prepare prescribed formulations for wellness solutions, pellet implants, and other medications for a wide range of conditions. We combine superior quality and expertise to protect your patients and your practice.

FDA-registered 503B outsourcing facility
Personalized service and support
Wide range of formulations available
Reliable supply chain across US
Become a Partner

Certified & Member

FDA Registered
DEA Registered
Certification
Member