Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur
The company is confident of addressing all the observations within the stipulated time
The company is confident of addressing all the observations within the stipulated time
The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
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
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