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Theqmnweeklybulletin

April 18, 2014

Vol. 6 No. 16

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FDA Bars Imports From Another Indian Manufacturer

The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More

Generic Makers Call for More EU-U.S. Collaboration on Approvals, Inspections

GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More

Indian Regulators Suspend Imports from Troubled Ranbaxy Plant

Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations. Read More

EMA Ups Stability Data Required for Changes to Active Substances

The EMA is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More

Impax Refiles NDA After Manufacturing Woes

Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More

Increase in 483s, Warnings Show Need to Boost Supplier Controls

Devicemakers saw an increase in 2013 in the number of FDA 483s that cite inadequate supplier controls; the finding is now one of the top five most common 483 findings for devicemakers. Read More

Lupin Recalls Suprax in the U.S.

Indian drugmaker Lupin Pharmaceuticals is voluntarily recalling three lots of its flagship cephalosporin oral antibiotic Suprax after the drug failed to meet specification in total impurities at the nine-month stability mark. Read More

Covidien Recalls Pipeline Embolization Device and Alligator Retrieval Device

Covidien is recalling certain lots of its Pipeline embolization devices and Alligator retrieval devices due to a defect in the coating applied to the delivery wire. Read More

Clarification

QMN Weekly Bulletin reported on April 4 that the FDA had announced six manufacturers, including West-Ward Pharmaceutical, had not voluntarily withdrawn their applications to manufacture high-dose acetaminophen products.  West-Ward says the company did voluntarily withdraw its application and received acknowledgement of the withdrawal from the FDA on March 25. Read More