Nivagen Pharmaceuticals, LLC
FDA 503B outsourcing facility
Sacramento, California
Key Takeaways
- FDA-registered 503B outsourcing facility since 2026
- Sterile compounding from bulk substances: Yes
- Not yet inspected by the FDA
- 1 FDA drug recall on record (2024)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- March 13, 2026
- Most recent registration
- March 13, 2026
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- Not yet inspected
Nivagen Pharmaceuticals, LLC has registered with the FDA as a 503B outsourcing facility but has not yet been inspected. The FDA inspects registered facilities on a risk-based schedule once drug production and distribution are confirmed.
FDA recall history
Nivagen Pharmaceuticals, LLC has 1 FDA drug recall on record in 2024, based on the FDA enforcement database. Breakdown: 1 Class II.
Recall reasons on record include presence of foreign tablets/capsules: a carbamazepine extended-release 400 mg tablet was.
| Date | Class | Product | Reason |
|---|---|---|---|
| September 2024 | Class II | Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95 | Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg. |
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
Compounded peptides and GLP-1s
Nivagen Pharmaceuticals, LLC has not assigned NDCs or filed product reports in the most recent FDA reporting periods. 503B outsourcing facilities are a primary supply route for compounded peptides and GLP-1s during FDA-listed shortages; PeptideGrids grades the evidence for each, including Semaglutide, Tirzepatide, BPC-157, Retatrutide. Browse the GLP-1 and therapeutic peptide databases.
Location
3100 Fite Cir, N/A, Sacramento, CA 95827-1805
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Contact
FDA-registered contact: Gopal Patel, 1-916-591-0160. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of Nivagen Pharmaceuticals, LLC with the California State Board of Pharmacy.
503B facilities in California
California has 7 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in California.
Frequently asked questions
Is Nivagen Pharmaceuticals, LLC registered with the FDA?
Yes. Nivagen Pharmaceuticals, LLC is a registered 503B outsourcing facility, first registered with the FDA on March 13, 2026 and most recently registered on March 13, 2026.
Has Nivagen Pharmaceuticals, LLC been inspected by the FDA?
Nivagen Pharmaceuticals, LLC has registered with the FDA but has not yet been inspected as a 503B outsourcing facility.
Has Nivagen Pharmaceuticals, LLC had any FDA drug recalls?
Nivagen Pharmaceuticals, LLC has 1 FDA drug recall on record (2024) in the FDA enforcement database.
What does Nivagen Pharmaceuticals, LLC compound?
Nivagen Pharmaceuticals, LLC has not filed product reports with NDC-assigned drugs in the most recent FDA reporting periods.
Where is Nivagen Pharmaceuticals, LLC located?
Nivagen Pharmaceuticals, LLC is located in Sacramento, California (3100 Fite Cir).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Nivagen Pharmaceuticals, LLC. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.