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Sun Pharma recalls drugs from troubled Halol plant Posted 11/09/2015

India-based Sun Pharmaceutical Industries (Sun Pharma) is once again having to recall drugs from its troubled Halol plant in Gujarat, India.

According to the US Food and Drug Administration Enforcement Report for the week of 26 August 2015, Sun Pharma has initiated a voluntary recall of 35,235 bottles of its generic version of GlaxoSmithKline’s anti-depressant Wellbutrin (bupropion hydrochloride) extended-release tablets in a dose of 200 mg. The reason for the recall is that during analysis of the 18-month long-term stability testing, the drug release results at the 4-hour time point did not meet specifications.

This latest recall follows a recall of 26,530 bottles of Sun Pharma’s generic version of Pfizer’s Effexor XR (venlafaxine hydrochloride extended-release) tablets in 2014, also due to dissolution problems. Before that, it recalled more than a quarter of a million bottles of venlafaxine as well as 128,363 bottles of the decongestant cetirizine again due to dissolution problems.

The Halol plant just adds to Sun Pharma’s troubles with the company’s ex-Ranbaxy India-based factories at Toansa, Paonta Sahib, Dewas and Mohali having been banned from exporting drugs to the US [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Sun Pharma to acquire Ranbaxy creating 5th largest generics firm [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 11]. Available from: www.gabionline.net/Pharma-News/Sun-Pharma-to-acquire-Ranbaxy-creating-5th-largest-generics-firm

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Source: US FDA

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