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Argentina recently agreed to open its borders to finished drug products from India, a policy change applauded by Indian manufacturers who now have access to the multi-billion-dollar market. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More
The FDA delivered its fifth warning letter to a compounding pharmacy in roughly two weeks, admonishing a Texas compounder for poor aseptic processing of sterile drugs. Read More
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts about the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
European regulators are asking drugmakers to submit information on products that were part of bioequivalence trials conducted at contract research organization GVK Biosciences’ India facility, after an inspection raised serious concerns about good clinical practice compliance. Read More
The FDA cited a trio of compounders for a wide swath of quality violations, igniting renewed criticism that the agency is “unjustified” in using a new law to enforce old violations. Read More
An FDA inspection of Impax Laboratories’ Taiwan plant has uncovered apparent manufacturing violations, raising new questions about the company’s plans to launch its proposed Parkinson’s disease drug Rytary. Read More
A deluge of warning letters to compounding pharmacies appears to have jolted the industry into taking FDA enforcement more seriously, quality experts tell DID. Read More
The FDA has slapped a warning on an Italian active pharmaceutical ingredient manufacturer for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. Read More
After initially rejecting FDA’s authority, a Texas compounding pharmacy acceded to the agency’s request to cease production and recall all of its sterile products due to quality concerns. Read More