The QMN Weekly Bulletin

FDA officials Sept. 14 asked Congress to clarify and enhance the agency’s authority to stop drug imports by uncooperative foreign facilities and to enforce drug product tracking.

By pushing inspector training and re-emphasizing a directive that investigators limit their focus to two facility systems, the FDA hopes to do a better job of inspecting device plants and other facilities.

An international offensive against online sellers of fake and illicit drugs has resulted in the seizure of some 2.5 million pills with an estimated value of $6.3 million.

AstraZeneca said it would invest $200 million to launch a new manufacturing facility in China to meet growing demand, including in rural areas.

Making pills that could save lives both in India and abroad, Indian pharmaceutical companies are growing faster than ever before.

A Clemson University researcher says over-the-counter drugs produced overseas may not be manufactured to the same safety standards as they are in the United States, but drugmakers say the products are safe.

Rhodes Technologies, a manufacturer of pharmaceutical chemicals, is facing fines for violating hazardous-waste laws, the U.S. Environmental Protection Agency said.

A Lodi contract manufacturer for the pharmaceutical industry said it is breaking ground on a $3.5 million addition that is the first phase of a plan to increase revenue and add jobs.

Sanofi’s Genzyme unit has officially opened a $206 million expansion at its 10-year-old biotechnology facility in Waterford, Ireland that will triple its fill/finish capacity and help restore supply levels for some of its critical medicines.