This registration enables companies to register the products (Orodispersible films and Transdermal systems) in UAE for commercialization
The investment enhances Lonza’s capabilities and flexibility to support both clinical and commercial supply and will play a key role in meeting the growing market demand for bioconjugates
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure
The company will engage with the agency to resolve the import alert at the earliest.
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
New facility is based at Lonza’s Bend, Oregon (US) site, a Center of Excellence for bioavailability enhancement
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company will respond to these observations within the stipulated time period.
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
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