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Theqmnweeklybulletin

April 11, 2008

Vol. 2 No. 15

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Health Canada Releases New Guidance on GMP Inspections

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. Read More

Firm May Face $2.2 Million in Fines for GMP Violations

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. Read More

EC Updates Guidelines for Sterile Drug Manufacturing

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

Actavis Buys Chinese API Manufacturing Firm

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

Genzyme Recalls Three Lots of Transplant Drug, FDA Says

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. Read More

India Converts Failing Vaccine Plants to Testing Labs

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. Read More

Laureate Announces Manufacturing Agreement With Alopexx

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. Read More

Inotek Closing Facilities, CEO Leaves

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. Read More

Pharma Firms Take to Contract Manufacturing

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. Read More