USFDA concludes Pre-Approval Inspection of Cadila Healthcare's injectable onco manufacturing facility
At Pharmez, Ahmedabad
Cadila Healthcare announced that the USFDA conducted a Pre-Approval Inspection (PAI) for Doxorubicin Liposomal, a complex oncological injectable at Alidac Pharmaceuticals, the injectable onco manufacturing facility, located at Pharmez, Ahmedabad from 18 March to 26 March 2019. The inspection concluded with one observation. Alidac is a 100% subsidiary of Cadila Healthcare. There was also a separate invitro BE inspection conducted by the Office of Study Integrity and Surveillance branch of US FDA for the same product which concluded with one observation.Powered by Capital Market - Live News
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First Published: Mar 27 2019 | 2:55 PM IST