Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023
Aurobindo will respond to the US FDA within the stipulated timelines
The company will submit its comprehensive response on these observations to the USFDA
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time
The audit is a pre-approval inspection for three products filed from the facility
The observations are procedural in nature
The company will be submitting the responses to US FDA observations within stipulated timeline
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