Just months after signing a consent decree for the manufacturing mess in its Ben Venue subsidiary, Boehringer Ingelheim finds itself on the firing line with the FDA again, this time for particle contamination in an API produced 4 and 5 years ago.
While the FDA has yet to give its final sign-off to this creative work-around, it has permitted the Johnson & Johnson subsidiary to release a lot at a time, the latest last week.
Ben Venue, the contract manufacturing arm of Boehringer Ingelheim, got a lighter sentence than expected in its consent decree with the FDA, as the agency is still allowing it to manufacture 100 drugs it considers "essential for patient care," looking to stave off possible shortages.
By jumping through some manufacturing hoops, Johnson & Johnson hopes to ease the shortage of its cancer drug Doxil by this fall.
The drug was in short supply for weeks after a change in where the anti-anxiety drug is manufactured.
Boehringer Ingelheim has invested €17 million expanding plants in Biberach, Germany, and Vienna.
A non-FDA approved drug from India and U.S. contract manufacturers will address cancer drug shortages resulting from production and quality problems at Ben Venue Laboratories ' now notorious Ohio...
Fallout from the closing of a Ben Venue Laboratories ' manufacturing facility over quality issues could prove deadly. The Bedford, OH, facility was the primary source of methotrexate, which is...