The capacity addition in Suwa is part of Saint-Gobain Life Sciences ongoing investment plan to globally expand production capacity for its products and services used throughout the bioprocessing industry
Construction will begin in early 2023, and the plant is scheduled to go onstream in 2025
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
The company will invest approximately €440 million to increase membrane manufacturing capacity in Carrigtwohill and to build a new manufacturing facility at Blarney Business Park, both in Cork, Ireland
Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases
East Syracuse site to serve as the LOTTE Center for North America Operations for LOTTE’s biologics contract development and manufacturing organization (CDMO) business
For the first time in India – fast, precise and efficient calibration of multi-channel micropipettes
The company exports mobile surgery equipment to over 100 countries from Pune
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
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