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Chitra Sethi, Managing Editor, BioPharm International
The biopharmaceutical company Genzyme Corporation (Cambridge, MA), is expected to be fined $175 million by the US FDA as part of the agency?s enforcement action to ensure that products manufactured at Genzyme?s Allston, MA, plant are made in compliance with GMP regulations.
The biopharmaceutical company Genzyme Corporation (Cambridge, MA), is expected to be fined $175 million by the US Food and Drug Administration as part of the agency's enforcement action to ensure that products manufactured at Genzyme's Allston, MA, plant are made in compliance with good manufacturing practice (GMP) regulations.
A series of manufacturing problems, including viral contamination at its Allston Landing plant, have resulted in shortages of Genzyme's blockbuster drugs: Cerezyme and Fabrazyme. The company reported that its first-quarter revenue was $1.07 billion, down from $1.15 billion for the corresponding period last year, because of the shortages of the two drugs.
Genzyme has not yet resumed full shipments of either drug. In a company statement, Genzyme stated that for the next two to three months, it would only be able to ship enough Cerezyme to meet 50% of global demand. The company also won't be able to ship more than 30% of Fabrazyme demand through the third quarter.
The consent decree also requires Genzyme to move its fill–finish operations to another location. If Genzyme fails to do so by deadlines determined by the FDA, the company would pay fines equal to 18.5% of revenues from sales of products manufactured in Allston. If Genzyme fails to comply with GMP standards over the next few years, it will have to pay $15,000 per day until it is compliant.
At an investors conference held on March 31, the company had announced that it will gradually phase out its fill–finish operations from the Allston plant. The first product to be moved will be Thyrogen, which is expected to be transferred in the third quarter of this year.
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