The QMN Weekly Bulletin

Health Canada’s Health Products and Food Branch Inspectorate has issued a revised guidance for drug companies aimed at improving the scheduling of inspections and delivery under the Drug Good Manufacturing Inspection Program.

Alleging that the company made significant good manufacturing practice violations, including shipping a recalled product, the FDA is seeking $2.2 million in fines against Advanced Bionics and its president.

The European Commission (EC) is detailing its expectations for manufacturers running media fills to assess aseptic processing operations.

Actavis, a leading generic pharmaceuticals company, has acquired a 90 percent share in Zhejiang Chiral Medicine Chemicals Company in China for an undisclosed amount.

Genzyme Corp. voluntarily recalled three lots of Thymoglobulin, a drug used during transplants, after the solution was found to have a different appearance than usual, the Food and Drug Administration said on its website.

The Indian government has reacted to the enforced closure of three of its oldest vaccine manufacturing plants by launching a plan to convert them to drug testing laboratories.

Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, announced that it has entered into a cGMP contract manufacturing agreement with Alopexx Pharmaceuticals, LLC.

Inotek Pharmaceuticals Corp. has decided to sell its drug plant in Israel and say goodbye to its CEO, among other developments, according to company officials.

Domestic pharmaceutical companies, including Square Pharmaceuticals and Eskayef Bangladesh Ltd., have slowly made inroads into the lucrative business of contract manufacturing of bulk drugs and formulations for global clients.