503B Outsourcing Facility: Empower’s Formula for Excellence

 Redefining Sterile Compounding with Precision and Scalability

Your business requires reliable, high-quality pharmaceutical manufacturing to drive growth in today’s healthcare industry. Empower Pharma offers affordable 503B sterile and non-sterile formulations on a dependable national network with enterprise scalability.  

The Empower Advantage

We are dedicated to delivering pharmaceutical solutions through rigorous testing, advanced technology, dependable and scalable inventory management.  

Empower Pharma upholds the highest pharmaceutical industry standards with our 503B cGMP compliant and FDA-registered outsourcing facilities in Houston, TX, and East Windsor, NJ.  Our cutting-edge manufacturing facilities are designed to support pharmacies, large clinic networks and specialized practices with:  

• Sterile injectable liquids and pellets  

• Quality control on the floor 

• ISO-5 Sterile Filling supported by ISO 7 Cleanrooms 

Comprehensive 503B Outsourcing Solutions for Every Need

Have the products you need when you need them. Our generous storage capacity and manufacturing efficiency offer competitive availability to better avoid shortages.  

With over 210,000 square feet of manufacturing and storage capacity, we ensure that every product we deliver meets the strictest quality and safety requirements.  

Take advantage of Empower’s reliable services and capabilities, including: 

• Two facilities: Houston, TX and East Windsor, NJ. 

• 210,000 Square feet of combined manufacturing and warehousing space 

• Two (2) sterile production lines with two (2) more by 2026  

• 30+ formulas currently produced, with future expansion of more than 40+ future formulas 

• Warehouse capacity of over 4,000 pallets 

• Future annual capacity of 110 million units 

Our Commitment to Quality 

Empower Pharma maintains high standards of quality and consistency through rigorous regulatory, voluntary, and third-party evaluations.   

As an FDA-registered 503B outsourcing facility, we follow the same comprehensive quality standards as traditional pharmaceutical manufacturers.  

Here’s how we prioritize quality: 

• cGMP Compliant: Our operations adhere to Current Good Manufacturing Practices, ensuring that every product is consistently produced with precision and care. This includes maintaining exceptional standards for personnel, facilities, and materials.  

• FDA-Registered Facility: Our facilities undergo regular unannounced inspections by the FDA, ensuring compliance with stringent quality and safety guidelines.  

• DEA Registered: Manufacturer, Distributor, Importer and Exporter, for scheduled IIIN controlled substances.  

• Supplier verification: We verify that all API’s are from an FDA-registered manufacturer and maintain consistent supply and quality standards, like ISO 9001. We perform three-lot testing and specific tests for intended use, such as endotoxins and bioburden.  

• Manufacturing excellence: Our manufacturing process has strict batch and lot controls. During production, in-process checks are conducted, followed by a 100% visual inspection and Acceptance Quality Limit (AQL) process by qualified personnel.   

• Cleaning Validation: We implement thorough, documented processes to confirm equipment is free of contaminants and that cleaning procedures are effective.  

• Environmental and Clean Room Monitoring: Our facilities are meticulously monitored to ensure a clean and safe environment for production.  

• On-the-Floor Quality Specialists: Our highly skilled team, including pharmacists, chemists, engineers, and biomedical professionals, ensures exceptional quality in every process. 

• Product Testing and Stability: We rigorously test products under various conditions to establish stability, extend shelf life, and prevent unwanted degradation. Products undergo verification, and stability testing, covering potency, pH, endotoxins, subvisible particles, and container closure integrity. 

• Sterile Compounding: Our facilities host ISO 5 & ISO 7 cleanrooms where every injectable product (liquids & pellets) is thoroughly tested for potency, sterility, and stability to uphold the highest levels of safety and quality. 

• Post-manufacturing QA: Products undergo rigorous checks before release after manufacturing ensuring compliance with internal specifications. Retention samples and Certificates of Analysis are also issued.   

Delivering Volume & Value 

Ensure your organization has access to the pharmaceutical solutions it needs, tailored to its unique demands. 

Our breadth of manufacturing capabilities allows us to produce an extensive array of pharmaceutical products, from sterile injectables to pellets.  By leveraging advanced, streamlined technologies, we can efficiently scale production while maintaining the flexibility to address both specialized and high-volume requirements—all at a reasonable cost.  

We are equipped to scale with demand and offer support when shortages arise. By maintaining a large, well-managed inventory, we ensure a consistent supply of high-quality medications, even during periods of increased demand.  

Leverage Empower’s economies of scale and take advantage of competitive pricing without compromising on quality to support better overall health outcomes. 

Nationwide Reach, Unmatched Reliability 

With our streamlined, vertically integrated supply chain and efficient inventory management we help ensure medications are consistently available, reducing your organization’s risk of shortages. With a focus on supply chain reliability, we provide access to high-quality ingredients and materials, striving to maintain continuous product availability to meet the growing demand for compounded medications. 

We are committed to maintaining licensure nationwide, ensuring broad accessibility, though state requirements may change over time. 

The Experts Behind the Scene

We are proud to have a diverse team of dedicated professionals working together to serve the needs of healthcare professionals and systems.  

Our team includes board-certified pharmacists, skilled engineers, biomedical scientists, R&D, and executive level business supports all committed to delivering excellence. As well as dedicated quality teams with expertise of specialized technicians, quality assurance professionals, and regulatory compliance specialists to ensure every detail meets, and most of the time, surpasses the highest standards. 

This collaborative effort enables us to provide exceptional compounded 503B outsourcing that prioritizes quality, affordability, scalability and assured delivery—because we understand how much it matters to the healthcare and wellness providers we serve. 

Why Partner with Empower Pharma?

Every healthcare provider and pharmacy has unique needs when it comes to pharmaceutical compounding. That’s why we offer solutions designed to fit your specific requirements. Whether you’re looking for reliable, high-quality sterile injectables, or need a partner to scale your operations, we’re here to help.

Our team of experts are committed to making your growth smooth and efficient. With over 210,000 square feet of manufacturing space, two FDA-registered facilities, and cutting-edge technologies, we are equipped to handle your compounding needs with precision and care.

• Consistent Quality: Our rigorous quality control processes ensure every product is produced to the highest industry standards.
• Scalable Solutions: With our large-scale manufacturing capabilities, we can meet your growing demands while maintaining top-notch quality.
• Nationwide Availability: Our expansive network ensures your medications are delivered when and where you need them.
• Expert Support: From regulatory compliance to technical guidance, our team is dedicated to supporting you every step of the way.

Let’s work together to elevate your pharmaceutical services, learn more and get started here.