Good news for Ranbaxy plant in US

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Good news for Ranbaxy plant in US

Generics/News | Posted 08/11/2013 0 Post your comment

Ranbaxy Laboratory’s (Ranbaxy) US-based plant, Ohm Laboratories (Ohm), has successfully passed an FDA inspection, according to an announcement on the generic drugmaker’s website.

Ranbaxy announced on 4 October 2013 that Ohm had received a copy from the US Food and Drug Administration (FDA) of its Establishment Inspection Report (EIR) for its December 2012 inspection. FDA issues an EIR to a company or an establishment that was subject of an FDA or FDA-contracted inspection when the regulator determines the inspection to be ‘closed’.

This is great news for Ranbaxy, owned by Japan-based Daiichi Sankyo, as it would allow the company to continue supplying from this site. This is vital at the moment when Ranbaxy’s three India-based facilities – Paonta Sahib, Dewas and Mohali – are all under FDA import alerts and banned from supplying drugs to the US.

Ohm had been under investigation since 2009 when FDA first issued a warning letter to the site concerning good manufacturing practice violations. The facility was also part of FDA’s consent decree, which Ranbaxy signed in January 2012 [1]. However, this clearance from FDA means that Ranbaxy could potentially move some of its pending applications to Ohm from its Mohali manufacturing site to avoid delays in product launches.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy consent decree with FDA submitted to court [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 8]. Available from: www.gabionline.net/Generics/News/Ranbaxy-consent-decree-with-FDA-submitted-to-court

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Source: Ranbaxy, FDA, Business Standard India