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Nephron Pharmaceuticals announces availability of albuterol sulfate inhalation solution in 25mg/5ml vials

Nephron Pharmaceuticals announced that the company is now offering 0.5% albuterol sulfate inhalation solution in 5 ml vials for direct shipping to US medical facilities in response to a nationwide shortage. Ritedose Pharmaceuticals recently announced that if would begin manufacturing 0.5% albuterol in response to the shortage. Nephron notes that has been manufacturing 0.5% 0.5ml albuterol inhalation solution under an ANDA approved in 2001; according to the FDA Drug Shortages database, that product is currently listed as available “on allocation.”

The FDA issued a warning letter to Nephron in October 2022 citing numerous cGMP violations, including cross contamination, microbial contamination, and issues with quality control systems.

Nephron CEO Lou Kennedy commented, “Patients, families and healthcare providers should never worry about access to life-saving medication, and here at Nephron, making sure they have what they need is precisely what keeps us motivated. As we continue to keep the needs of patients and families a top priority, they can count on us, and that makes us proud.”

Read the Nephron Pharmaceuticals press release.

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published on June 1, 2023

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