09192017Headline:

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Greg Webb
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Generic Drug Maker Faces Manufacturing Violations

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Indian generic drug manufacturer, Ranbaxy Laboratories, has experienced many manufacturing violations over the past two years at one of its plants in India. Although it is only a minor player in the United States generic drug market, it accounted for about twenty-nine million prescriptions in 2009. Recently, the company has come under more scrutiny for significant violations at one of its plants in the United States, Ohm Laboratories in Gloversville, New York, which manufactures oral medications.

According to a report published by the Food and Drug Administration (FDA), Ohm did not properly investigate quality-control problems at the plant, such as black particles found in a bottle of metformin oral solution, a diabetes drug, and floating cardboard particles found in batches of ranitidine solution, an ulcer drug. The report also said the plant failed to test an acceptable number of each drug product, did not train employees in certain procedures required by good manufacturing regulations, and failed to inform regulators of product problems in a timely manner. There were no procedures for process controls and production, which would ensure that all of the drug products would have the same identity, quality, purity and strength.

Although the violations occurred last summer, the report was not released until recently after the New York Times filed a document request under the Freedom of Information Act. A subsequent press release issued by Ranbaxy last December stated the company has retained a consulting firm to advise it on the issues cited by the FDA report. It also said that Ohm Laboratories operated two plants other than the Gloversville facility and that those manufactured most of the products the company supplied in the United States. The FDA is still, however, concerned about Ranbaxy’s overall record of integrity and manufacturing problems. Just last year, for example, federal regulators determined that one of the company’s plants falsified data and test results.

Daiichi Sankyo, a Japanese drug manufacturer that bought a controlling interest in Ranbaxy in 2008, said it took manufacturing quality seriously and was committed to working with the FDA to resolve any outstanding issues. Daiichi Sankyo and Ranbaxy executives have put together a joint task force to ensure quality-control systems are in place and will improve.