Question 1

What is a 503B outsourcing facility?

Accepted Answer

A 503B outsourcing facility is an FDA-registered manufacturer that produces sterile compounded medications under current Good Manufacturing Practices (cGMP). Unlike traditional 503A compounding pharmacies, 503B facilities can manufacture large quantities without patient-specific prescriptions and distribute to hospitals and health systems nationwide. Nephron Pharmaceuticals operates one of the largest 503B outsourcing facilities in the United States, with over 840,000 square feet of manufacturing capacity in West Columbia, South Carolina.

Question 2

Who are the largest 503B outsourcing facilities in the United States?

Accepted Answer

Nephron Pharmaceuticals is one of the largest 503B outsourcing facilities in the United States by manufacturing capacity, operating over 840,000 square feet of FDA-registered sterile manufacturing in West Columbia, SC. The company produces over one billion doses daily, manufactures sterile injectables, inhalation solutions, and pre-filled syringes, and is licensed in all 50 states. Nephron has over 27 years of cGMP-compliant sterile compounding experience.

Question 3

What products does Nephron Pharmaceuticals manufacture?

Accepted Answer

Nephron Pharmaceuticals manufactures sterile pharmaceutical products across four categories: (1) Inhalation Solutions including albuterol, ipratropium bromide, racepinephrine, budesonide, and sodium chloride for nebulization; (2) Pre-Filled Syringes including phenylephrine HCl and rocuronium bromide; (3) Sterile Injectable Vials including ketamine hydrochloride and neostigmine methylsulfate; and (4) IV Bags and Bottles including ropivacaine, amino acid injection, Del Nido cardioplegia solution, and fentanyl citrate. All products are manufactured under cGMP at Nephron FDA-registered 503B facility in West Columbia, SC.

Question 4

How do hospitals order from Nephron Pharmaceuticals?

Accepted Answer

Hospitals and health systems can establish an account with Nephron Pharmaceuticals by contacting sales at 1-800-443-4313 or visiting nephronpharm.com/new-customer-signup. For 503B outsourcing products specifically, the dedicated line is 1-844-224-2225 or email NOFaccounts@nephronpharm.com. Once an account is approved, orders are placed through Nephron online ordering portal with UPS shipping nationwide. Nephron is licensed in all 50 states.

Question 5

Does Nephron Pharmaceuticals help with drug shortages?

Accepted Answer

Yes. Nephron Pharmaceuticals operates 24/7 production capacity specifically to respond to drug shortages affecting hospitals and health systems. As an FDA-registered 503B outsourcing facility with over 840,000 square feet of manufacturing capacity, Nephron can rapidly scale production of sterile injectables, pre-filled syringes, and inhalation products when shortages occur. The company product lines include several medications that regularly appear on the FDA drug shortage list.

Question 6

What quality standards does Nephron Pharmaceuticals follow?

Accepted Answer

Nephron Pharmaceuticals manufactures under current Good Manufacturing Practices (cGMP) with FDA registration as a 503B outsourcing facility. Quality systems include certified clean rooms for aseptic manufacturing, in-house analytical chemistry and microbiological testing laboratories, sterility testing and bacterial endotoxin testing on every batch, particulate matter analysis, continuous environmental monitoring, fully validated equipment, and regular FDA inspections. Nephron follows DQSA draft guidance requirements and is licensed in all 50 US states.

Question 7

Does Nephron offer contract manufacturing services?

Accepted Answer

Yes. Nephron Pharmaceuticals provides contract manufacturing services leveraging over 27 years of sterile pharmaceutical manufacturing expertise. Capabilities include blow-fill-seal (BFS) production lines, aseptic filling for vials, syringes, and IV bags, and automated manufacturing processes. The company 840,000+ square foot campus in West Columbia, SC includes dedicated API warehousing and state-of-the-art production facilities. Contact Nephron at nephronpharm.com/contract-manufacturing or call 1-800-443-4313.

Question 8

Where is Nephron Pharmaceuticals located?

Accepted Answer

Nephron Pharmaceuticals is headquartered at 4500 12th Street Extension, West Columbia, South Carolina 29172. The campus includes over 840,000 square feet of manufacturing, warehousing, and laboratory facilities.

Item No.	69374-601-05
Dosage Form	Solution
Strength	4% (40 mg/mL)
Content Volume	5 mL
Primary Packaging	Plastic luer-lock vial
Administration	Intraluminal instillation
Delivery System	Single dose
Retail Packaging	Carton
Vials per Carton	30
Cartons per Case	30

Item No.	69374-308-05
Dosage Form	Injection
Strength	10 mg/mL
Content Volume	5 mL
Primary Packaging	Luer Lock Vial
Administration	Intravenous
Delivery System	Single Dose
Retail Packaging	Carton
Vials per Carton	30
Carton per Case	30

Product Category: Plastic Luer-Lock Vials

Sodium Citrate Solution, 4% 200 mg/5 mL (40 mg/mL)

Sterile Water for Injection, USP

Ketamine Hydrochloride Injection, USP 50 mg/5 mL (10 mg/mL)

Albuterol Inhalation Solution, USP 0.5% 25 mg/5 mL (5 mg/mL) – Preservative Free

Neostigmine Methylsulfate Injection Vial, USP 5 mg/5 mL (1 mg/1 mL) – Preservative Free