Enforcement Report for Week of June 28, 2023
Enforcement Report - Week of December 28, 2022
Enforcement Report - Week of April 6, 2022
Aurolife Pharma Receives FDA Warning Letter
In the antiseptic world of drug manufacturing, cleanliness is key and outside contamination is a drugmaker's worst enemy. That's why, generally speaking, chronic water leaks from the ceiling are a bad thing—a fact an Indian generics maker is having to learn the hard way.
Aurolife Pharma's Generic Oxycodone Hydrochloride Receives Approval in US
Enforcement Report - Week of September 25, 2019
Aurobindo has been knocked by the FDA for its role in global “sartan” recalls after allowing tainted active pharmaceutical ingredients into their drugs. Now, a mislabeling snafu is pulling even more of the drugmaker’s generics off U.S. shelves.
Drug firm Aurobindo Pharma on June 7 said the company, its Director P V Ramprasad Reddy and step-down subsidiary Aurolife Pharma LLC, have been made party to a litigation proceeding in the US.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.