GMP deviators keep paying

CGMP violations can continue to sting long after the warning letter arrives. Caraco Pharmaceutical, for example, which continues its push toward regulatory compliance in an effort to resume manufacturing in Detroit, saw sales drop 36 percent to $78.4 million, in the last quarter, thanks in part to its FDA-mandated manufacturing halt and drug seizures.

According to sister publication FiercePharma, Caraco may be considering moving the made-in-Detroit products to a less-troubled facility and a friendlier environment: an Indian plant owned by parent company Sun. Such a move could help the generics maker realize resumed revenues "in less than six months," says Caraco CEO Jitendra Doshi, in a press report.

Genzyme (GENZ) also is feeling a lingering sting. Its shares dropped 5% in the third quarter, following the temporary shutdown and cleanup of a virus-contaminated manufacturing facility outside of Boston. Genzyme has lowered its 2009 financial forecast.

The company has since resumed operations at the plant, which is used to make Cerezyme and Fabrazyme. It says it expects to begin shipping both before year's end.

- here's the FiercePharma item
- here's the Caraco article
- read the Genzyme item

Suggested Articles

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.

Continuing its expansion efforts, Japan’s Fujifilm will make a major investment in its U.S. gene therapy operation in Texas.