Aurobindo drug recalled in the US

On Friday, Ranbaxy Laboratories voluntarily recalled a few batches of generic Lipitor from the US market. But the Gurgaon-based company is not the only Indian drugmaker to voluntarily recall drugs from the US market this year. An enforcement report brought out by the US Food and Drugs Administration (FDA) on November 14 shows Hyderabad-based Aurobindo Pharma voluntarily recalled a batch of Zolpidem drug from the US market in March this year.

According to the US FDA enforcement report, the Zolpidem batch was recalled because of “adulterated presence of foreign tablets”. The FDA enforcement report said, “This product is being recalled because 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labelled Zolpidem Tartrate tablets USP 10 mg.”

Although this is a Class-II recall and not considered very severe, it is significant given the fact that the import of products from the company’s unit-3 facility were held by this FDA in the past, too, due to packaging discrepancies. US FDA resumed approving products from Aurobindo Pharma’s unit-3 only around June following its inspection in March.

The company did not reply to a detailed questionnaire sent by Business Standard on the matter.

After the company started getting approvals for products filed from unit-3 and its capacity was optimally utilised, it shifted some of the products to unit-7, which came up in 2010 and is a relatively new facility. Another of the company’s key manufacturing facility, unit-6, also situated in Andhra Pradesh, continues to be under US import alert since 2011 for serious violations of the US FDA’s manufacturing norms. Unit-6 is a cephalosporin-based medicine manufacturing unit and accounts for a significant portion of the company’s sales in the US. Recently, the US regulatory authorities conducted inspection of the facility but is yet to give a go-ahead.

According to analysts, the financial impact of the recall might not be much but it could be sentimentally negative for the company, particularly when it is facing inspection of its facilities by the regulator.

Zolpidem was originally developed and marketed by French pharma company Sanofi Aventis under the brand name Ambien. Apart from Aurobindo, many other drugmakers including Teva Pharmaceuticals, Caraco pharmaceuticals, Torrent Pharmaceuticals, Dr. Reddy’s Laboratories, and Ranbaxy sell the generic version of the drug in the US.

On Friday, Ranbaxy had announced a voluntary recall of some batches of its generic version of Lipitor from the US after it suspected presence of some foreign particles in its tablets.

The Daiichi Sankyo-owned company has been facing troubles in the world’s largest drug market since 2008 after manufacturing violations were found in three of its key facilities in India.

However, analysts say Aurobindo’s recall cannot be compared with that of Ranbaxy. “There is not much clarity on Ranbaxy’s recall of Lipitor generic — it could be a case of contamination, which is a serious recall. However, Aurobindo’s recall is just a labeling discrepancy involving one batch and does not look very serious,” an analyst said.

On Friday, shares of Aurobindo Pharma ended at Rs 172.60 on the Bombay Stock Exchange, down 2.29 per cent from the previous close.