Regulators keep watch over KV, Acino operations

Drugmakers in the U.S., Germany and India are feeling the regulatory heat.

KV Pharmaceutical has disclosed in financial documents that product shipments halted as part of a consent decree will resume in the fourth quarter "at the earliest." The St. Louis drugmaker says it continues to work with the FDA following recalls in 2008 of oversized tablets, as we've reported. KV ultimately pleaded guilty to criminal charges for manufacturing-related missteps, agreed to $27.6 million in penalties, and shuttered subsidiary ETHEX.

Meanwhile, European regulators have stopped sales of a blood clot treatment whose active ingredient was made in sub-par GMP conditions. The European Medicines Agency has recalled batches of eight generic versions Acino Pharma's clopidogrel, whose API hails from India.

The action follows inspection by German regulators of supplier Glochem Industries in Visakhapatnam.

Acino, based in Germany, sells the drug in Europe. It also licenses the drug to generics makers Sandoz, Hexal and Ratiopharm, which are also affected by the recall.

- here's the KV announcement
- read the Acino article

Suggested Articles

The partnership aims to make the production of vaccines that use adenovirus as vectors more cost-effective and contamination-free.

The FDA hit New Jersey-based CMO Tris Pharma with a warning letter, citing significant violations.

Celltrion remains optimistic it will get U.S. approval for its two biosimilar drugs, Rituxan and Herceptin, by the end of the year.