Evonik opens new facility for pharmaceutical lipids in Germany
New GMP facility for clinical and small-scale commercial pharmaceutical lipids
New GMP facility for clinical and small-scale commercial pharmaceutical lipids
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)
Fluor is providing architectural and engineering services and procuring equipment for the new 275,000 square-foot manufacturing facility that will house two manufacturing lines to double manufacturing capability
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
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.
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