The QMN Weekly Bulletin

A decision by Boehringer Ingelheim subsidiary Ben Venue Laboratories to release five finished lots of injectable anesthetic propofol that met product specifications yet significantly exceeded allowed levels of endotoxins during in-process testing has earned the company an FDA warning letter.

Smith & Nephew has begun a precautionary recall of knee implants from its TC-PLUS, VKS and RT-PLUS knee ranges.

An FDA inspection found that GE Ionics had no documentation to show employees received required training.

The Germany-based Evonik Industries AG, the third largest German chemical and specialty chemical manufacturer, is planning to expand its research and development center in Mumbai.

Gerresheimer AG is consistently continuing its strategy of globalization and extension of product offerings in the pharma and life-science sector.

The FDA announced on Wednesday that German drug maker Bayer AG is voluntarily recalling certain test strips for one of its blood-glucose meters as they appear to be faulty and are presenting blood sugar readings that are too-high by about 5 percent to 17 percent.

DSM Anti-Infectives has entered into a manufacturing agreement with Mumbai-based Arch Pharmalabs, a pharmaceutical major operating in the API and intermediaries business for manufacturing of generic APIs.

PL Developments, a Westbury-based over-the-counter pharmaceutical company, has acquired PAL Laboratories of Miami, Fla.

Even as a lack of clarity in regulations is preventing Indian medical device manufacturers from making their presence felt in the $2 billion domestic medical equipment market, foreign players, mostly from the United States, are increasingly finding the country a preferred destination.