Zydus Cadila's US arm Nesher Pharma gets 11 observations from USFDA

Medicine Photo: Reuters
Facilities of Cadila Healthcare Ltd. (Zydus Cadila)'s US arm, Nesher Pharmaceuticals (USA) LLC, have received 11 observations from the US Food & Drug Administration (USFDA), the Indian pharma company stated on Monday.

Nesher Pharma, a 100 per cent subsidiary of Zydus Pharmaceuticals USA, saw USFDA inspection at its two facilities located at St. Louis, Missouri from May 13 to May 31, 2019. Apart from three observations at one facility and eight at another, Nesher Pharma also bagged a 'voluntary action indicated' (VAI) recommendation from the regulator, as per Cadila Healthcare's filing on BSE. 

"This was a product specific pre-approval inspection with general cGMP and there were no Data Integrity (DI) related observations. The company is confident of addressing these observations and responding to the USFDA at the earliest," Cadila Healthcare stated in its BSE filing on Monday.

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