USFDA News

Zydus Lifesciences Faces USFDA Scrutiny: Six Observations at Gujarat API Unit Unveiled

Zydus Lifesciences reports six USFDA observations at its Gujarat API unit, unrelated to Data Integrity, amid a stock price decline. The company is confident in timely resolution.

Laurus Labs Faces USFDA Scrutiny: A Closer Look at the Recent Form 483 Observation

Laurus Labs' US subsidiary, Laurus Generics Inc, received a Form 483 with one observation from the USFDA following a detailed inspection. The company is committed to addressing the...

Aurobindo Pharma's Hyderabad API Unit Faces USFDA Inspection with Two Observations

Aurobindo Pharma reports that the USFDA inspected its subsidiary Apitoria Pharma's API manufacturing facility in Hyderabad with two procedural observations, to be addressed within ...