Your Patients Deserve More Than a Compounded Guess
Nivagen is a California based, FDA-registered 503B outsourcing facility that operates under the same cGMP standards as commercial drug manufacturers. Every product your practice uses has been tested for potency, screened for sterility, and released with full documentation before it ever reaches your treatment room.
Become a Hospital Customer Become a Hospital CustomerQuality you can trust, care that your patients deserve
We manufacture pharmaceutical-grade solutions that are built specifically for the wellness practice and hospital. No guesswork on concentration. No uncertainty about shelf life. No scrambling when a supplier runs short.
Every product ships from the same cGMP facility, under the same quality system, to the same standard. It's the foundation that lets you deliver consistent products, protect your patients, and grow a successful practice built on trust.
A Range of Solutions Designed to Meet Different Health Needs
Our team is dedicated to advancing wellness through care that puts the patient first. We support healthcare providers across the spectrum of functional medicine, nutrition therapy, weight management, longevity solutions, and metabolic health, helping deliver solutions tailored to enhance the health journey. By bridging expertise with compassionate care, we empower providers to address the full spectrum of wellness needs. Together we're redefining what comprehensive, patient-centered care looks like.
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Become a Wellness CustomerBuilt for the hospital floor and the wellness clinic, all from one cGMP facility
Nivagen supplies two channels that other facilities usually split across two vendors:
For hospitals and surgery centers: Ready-To-Use IV bags, prefilled syringes, vials and cartridges across critical-care categories — in standardized concentrations aligned to FDA safety standards
For wellness and physician practices: (med spas, longevity and IV-therapy clinics, and functional and integrative medicine): Nivagen supplies 'ready-to-use' products built to the same cGMP standard as our hospital line.
Setting Higher Standards with 503B Compounding
Nivagen supplies two channels that other facilities usually split across two vendors:
Comprehensive finished product testing, including potency, endotoxin, and sterility testing- Rigorous stability studies supporting validated Beyond-Use Dates (BUDs)
- USP <797> compliant sterile compounding
- Independent Quality Unit separate from manufacturing operations
- Validated manufacturing processes and equipment
- Manufactured in accordance with current Good Manufacturing Practice (cGMP) and current Good Laboratory Practice (cGLP) standards
- Certificate of Analysis (CoA) provided with every product
Comprehensive product testing
Rigorous stability studies
Compliant sterile compounding
Certificate of Analysis with every product
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Our Team, Your Partner
We have an accomplished team focused on fulfilling our vision: to deliver high-quality, affordable, ready-to-use medicines to patients and healthcare professionals across the United States. Our team caters to acute care units, hospitals, and the growing practitioner wellness market — all under one roof, leveraging our strong coast-to-coast network.
Backed by decades of combined experience in pharmaceutical manufacturing, our pharmacists, scientists, and quality professionals bring the discipline of large-scale operations to every product we compound — so health care providers can count on us as a true partner, not just a supplier.
Product Pipeline – Coming Soon!
| Wellness Products | Format | Channel | Target Availability |
|---|---|---|---|
| Glutathione 200 mg/mL, 30 mL | Multi Dosage Vial (MDV) | Wellness | Coming Soon |
| Methylcobalamin (B12) 5 mg/mL, 30 mL | Multi Dosage Vial (MDV) | Wellness | Coming Soon |
| B Complex, 30 mL | Multi Dosage Vial (MDV) | Wellness | Coming Soon |
| L-Arginine Injection 200mg/mL, 30 mL | Multi Dosage Vial (MDV) | Wellness | Coming Soon |
| NAD+ Injection 100mg/mL, 10 mL | Multi Dosage Vial (MDV) | Wellness | Coming Soon |
| Levocarnitine 500mg/mL, 30 mL | Multi Dosage Vial (MDV) | Wellness | Coming Soon |
| Magnesium Chloride Injection 200mg/mL, 30 mL | Multi Dosage Vial (MDV) | Wellness | Coming Soon |
| Alpha Lipoic Acid Injection 25mg/mL, 30 mL | Multi Dosage Vial (MDV) | Wellness | Coming Soon |
| Vitamin D3 50,000 units/mL, 30 mL | Multi Dosage Vial (MDV) | Wellness | Coming Soon |
| Hospital Products | Format | Channel | Target Availability |
|---|---|---|---|
| Sodium Bicarbonate 150 mEq / 1,000 mL | Metabolic acidosis, CPR, electrolyte correction | Hospital | Coming Soon |
| Diltiazem 1mg/mL, 125mL | Atrial Flutter and Paroxysmal Supraventricular Tachycardia | Hospital | Coming Soon |
| Fentanyl + Bupivacaine 2mcg/mL & 0.125%, 100mL | Epidural or regional pain management | Hospital | Coming Soon |
| Fentanyl + Bupivacaine 2mcg/mL & 0.125%, 250mL | Epidural or regional pain management | Hospital | Coming Soon |
These products and statements are not approved by the FDA. The FDA does not verify the safety, efficacy, or quality of compounded drugs.
Exceptional quality behind every lot
Every lot that we produce is manufactured in state-of-the-art facilities using advanced machines found in commercial cGMP manufacturing plants, in compliance with 21 CFR 210/211, PDA (Parenteral Drug Association), and 503B guidelines. From the moment raw material reaches our dock to the moment product leaves the building, our team runs every analytical test on world-class equipment to ensure consistency and purity. Every sterile preparation meets or exceeds USP <797>, with stability-based dating established through rigorous testing.
We are DEA registered, cGMP compliant, and compliant with the California State Board of Pharmacy.
Behind the facility stands PAI Pharma, a pharmaceutical manufacturer with more than fifty years in oral liquid and unit-dose production. With previous experience in the 503B industry, PAI Pharma has built Nivagen's 503B operation on that foundation, establishing a coast-to-coast platform that reaches from Greenville, South Carolina to Sacramento, California.
FDA
Registered
US FDA Registered Outsourcing Facilities
Our facilities are registered as Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Frequently Asked Questions
Q: What types of compounded dosage forms are available at Nivagen 503B?
A: IV bags, prefilled syringes, single-dose vials, and multi-dose vials.
Q: Who can order from Nivagen 503B?
A: Pharmacies, hospitals, clinics, licensed IV hydration clinics, physician practices, government medical facilities, and other licensed healthcare providers.
Q: Does Nivagen 503B provide a COA?
A: Yes, with every product shipment.
Q: Is Nivagen facility DEA registered?
A: Yes.