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Successful FDA Inspection at Gerresheimer Peachtree City, USA

The Gerresheimer subsidiary in Peachtree City, USA, was named an approved “Contract Manufacturer for VERO Biotech’s GENOSYL Delivery System (DS), drug substance intermediate” for the disposable cassette of the company’s third generation of the first tankless inhaled nitric oxide delivery system. As part of the product’s approval on the American market, the entire manufacturing strategy was examined by the United States Food and Drug Administration.

Important new development in clinical use

The FDA inspection took place from 17 November to 12 December 2022 at the Gerresheimer facility in Peachtree City. During this time, production at the facility was inspected by drug and device Consumer Safety Officers, who evaluated the management system and production process for disposable cassettes, from incoming raw materials to finished products.

This inspection was a key step for the approval of the third generation GENOSYL Delivery System (DS). The approval presents an important new development in the clinical use of inhaled nitric oxide, and the pent-up demand for this third generation innovation demonstrates its increasing value to the acute care community.

Numerous benefits for patients and medical professionals

GENOSYL Delivery System (DS) for inhaled nitric oxide was approved by the US Food and Drug Administration in December 2019 and was the first tankless delivery system for inhaled nitric oxide. Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension.

Unlike tank-based systems, GENOSYL DS generates and delivers iNO at the bedside using a small disposable cassette. This eliminates the need for hospitals to manage large, cumbersome tanks and helps to simplify clinical workflow. The recently approved third generation GENOSYL DS also includes an innovative dual-cassette design and secondary adaptive sensor technology to further optimise patient care.