Nephron Pharmaceuticals Announces 503B License in California
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Jul 10, 2017, 17:58 ET
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WEST COLUMBIA, S.C. , July 10, 2017 /PRNewswire/ — The California Board of Pharmacy granted one of its first licenses to the Nephron 503B Outsourcing Facility on July 5, 2017 .
The new California licensing regulation was introduced by the Board of Pharmacy in early 2017. Inspection reports of the Nephron facility indicate it complies with all cGMP standards and 503B outsourcing regulations required by the FDA.
Nephron, located in West Columbia, S.C. , is now licensed in 48 states, and is distributing products to hospitals and surgical centers across the United States .
Nephron manufactures 8.4% Sodium Bicarbonate 50mL Injection in a prefilled syringe. In addition, Atropine Sulfate, Calcium Chloride, and Labetalol Hydrochloride, are available on the National Drug Shortage list. Additional products from the 503B Outsourcing Facility include Neostigmine Methylsulfate, Succinylcholine Chloride and others.
“We have escalated our production and recruiting efforts in recent weeks,” said Lou Kennedy , CEO of Nephron Pharmaceuticals. “We have increased batch sizes to accommodate more hospitals, and have recruited 100 new sterile pharmacy technicians and PharmD employees.” “New products, including sterile filled bags, sterile diluents, and controlled pain management medications are in the pipeline,” remarked Kennedy.
Nephron 503B Outsourcing Facility products are manufactured on fully validated equipment and are verified with advanced in-house analytical, chemistry and microbiological testing. The Company stands by its commitment to distribute only the highest quality medication, after all test results meet specifications.
Nephron produces over 1 billion sterile doses annually from its ISPE award winning facility.