Sun Pharma pulls chemotherapy made at Gujarat plant

By Gareth Macdonald contact

- Last updated on GMT

Sun Pharma pulls chemotherapy made at Gujarat plant
Indian drugmaker Sun Pharmaceutical has recalled 200 vials of the cancer drug gemcitabine in the US over concerns about its sterility.

According to a report by the US Food and Drug Administration (FDA​) tests conducted on a different batch of the drug made at the same plant in Gujarat, India detected a “particle excursion” raised questions about the sterility of the recalled vials.

The withdrawal was initiated on April 9 by Sun’s unit Caraco Pharmaceutical Laboratories.

Sun Pharma declined to comment when contacted by in-Pharmatechnologist.com.

Related topics: Regulatory & Safety, QA/QC

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