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With three drug recalls in about two years after Pfizer Inc tied up with Indian partners Aurobindo Pharma and Claris Lifesciences, the US-based drug-maker is taking up its concerns with these suppliers.
“We are discussing these concerns with our suppliers and will take whatever steps are necessary to ensure the safety of patients and the quality of the products we provide,” Pfizer Inc's spokesperson told Business Line , in an e-mailed response from New York. The response was to whether three recalls (the third being last Saturday) put pressure on the American multinational's alliances with the Indian drug-makers.
The latest recall
Over the week-end, Pfizer's wholly-owned subsidiary Greenstone LLC had said it was voluntarily recalling certain lots of Citalopram 10mg Tablets (100-count bottle) and Finasteride 5mg Tablets (90-count bottle), distributed in the US market.
“The recall is due to the possibility that incorrect labels have been placed on the bottles by a third-party manufacturer. This is the only lot number being recalled and no other lots or markets are believed to be impacted,” a company statement had said.
Confirming that the third party was Hyderabad-based Aurobindo Pharma, Pfizer Inc spokesperson clarified that the latest incident was “not related to the import ban put in place by US FDA (Food and Drug Administration).”
The latest Aurobindo incident is the third, the spokesperson confirmed.
Earlier this year, the US regulatory authority has issued an import ban on certain injectibles and medicines made at Aurobindo's plant. In fact, Aurobindo had then said that the affected plant generated sales of about $2.5 million a month.
This recall had come after an earlier US regulatory issue with supplies from Ahmedabad-based Claris.
Pfizer Inc had entered into sourcing agreements with Claris and Aurobindo in 2009. In January 2010, it forged a similar sourcing agreement with Bangalore-based Strides Arcolab.
Without indicating if the alliances with the Indian companies would be reviewed, the company said: “Pfizer remains focused on the quality of all its products, no matter if they are made internally or externally, and we demand the same high level of quality regardless of source.”
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