Sun Pharma’s Gujarat site under FDA import alert

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Sun Pharma’s Gujarat site under FDA import alert

Generics/News | Posted 06/06/2014 0 Post your comment

Sun Pharmaceutical Industries’ (Sun Pharma) response to the US import ban on products produced at the company’s Gujarat site is inadequate, according to a warning letter issued by the US Food and Drug Administration (FDA) on 7 May 2014.

FDA banned imports from Sun Pharma’s Gujarat plant in March 2014 due to violations of current good manufacturing practice (GMP). Reasons stated for the ban included incomplete laboratory records, failure to label raw materials correctly, failure to keep records of drug batches and lack of appropriate education, training and experience for staff at the site.

The ban came as a result of inspections carried out by FDA during 13–16 November 2013.

The response of Sun Pharma to the ban has been noted by FDA to be ‘inadequate’ and lacking ‘sufficient corrective actions’, despite additional correspondence from the company in January and March 2014. Sun Pharma was also accused of frequently performing ‘unofficial testing’ of samples, then disregarding the results, and reporting results from additional tests instead.

The Gujarat plant, which makes the antibiotic cephalosporin, is one of Sun Pharma’s 25 manufacturing plants. The company expects the import ban to only have a negligible financial impact, since the site accounts for below 1% of the company’s revenue [1].

Reference

1. GaBI Online - Generics and Biosimilars Initiative. US will continue to buy Indian generics despite quality concerns [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 6]. Available from: www.gabionline.net/Reports/US-will-continue-to-buy-Indian-generics-despite-quality-concerns

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Source: FDA