Nureca's subsidiary receives ISO 13485 certification for Indian medical device facility
The certification will open new avenues for our flagship brand “Dr Trust”, enabling them to export these devices to many more countries
The certification will open new avenues for our flagship brand “Dr Trust”, enabling them to export these devices to many more countries
This win is on the back of a prestigious order from Reliance Life Sciences
Construction is now underway with the facility scheduled to be operational by 2025
The inspection of the facility was conducted from August 16-19, 2022.
The company will address the observations within a stipulated timeline working with the regulators
This inspection continues a series of successful inspections by Swissmedic in Vionnaz with the first inspection in 2015 followed by 2016, 2017 and 2020.
The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties
This new facility integrates multi-channel chip, micro-mixer system, and complex preparation system into a multi-channel micro-mixer core LNP manufacturing platform
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The Board also decided that Auro Vaccines will explore the possibilities of offering contract manufacturing to global vaccine developers
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