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Once again, Mylan Laboratories is having grief over its Agila Specialties unit.

Nearly three years ago, Mylan trumpeted a $1.6 billion agreement to buy Agila, which is based in India, in a bid to become a major player in the market for injectable drugs. The big generic drug maker consummated the deal later that year, but even before it closed, Agila was struggling with quality control issues at some of its nine plants, and the troubles continue to persist.

The latest problem has surfaced in Poland. Last summer, regulators found 29 major deficiencies in the Agila plant there and reported finding bacterial contamination, which jeopardized the stability of the final products made at the facility, according to Polish regulators (see the third listing). Last June, Mylan recalled batches of an antibiotic made at the facility due to impurities.


As a result of the infractions, Mylan decided last October to suspend production, although the move was only disclosed yesterday on the Polish government web site. We asked Mylan about any progress being made to correct the manufacturing problems and when production will resume, and we will update you accordingly.

The manufacturing issues at the Agila plant there are only the latest Mylan has encountered. Last August, the US Food and Drug Administration issued a warning letter to a pair of Agila plants in India following inspections made in 2014 and early 2015. Among the problems cited were bacterial contamination and a failure to determine why some batches of products contained impurities.


After the FDA issued its warning, Mylan hurriedly released a statement saying the company was taking “extensive action” to integrate the Agila business into its “One Quality Standard” manufacturing program to ensure its “leading position as a high quality, reliable source” of injectable drugs.

Back in September 2013, which was seven months after Mylan proposed to buy the injectables unit and two months before the deal was completed, the FDA issued a warning letter to Agila for a host of quality control problems, including sterility issues. The warning resulted from FDA inspections in June 2013.

Of course, manufacturing snafus occur regularly — pharmaceutical manufacturing is a complicated affair and even the biggest companies run into difficulties. But the troubles at Agila have placed Mylan on the defensive, because the drug maker is sensitive to any impression that Agila may be a perennially troubled unit.

“This raises questions about quality organization on a corporate level,” said Barry Friedman, a regulatory compliance consultant. “This happens often in acquisitions. Supposedly, companies conduct due diligence but it doesn’t always include quality, unfortunately.

“The FDA may eventually swoop down,” he added. “I think that’s where this may be headed. When you have that many facilities with that many problems, it appears that no one is at the rudder of the ship.”

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