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Dr Reddy’s could move manufacturing site with view to FDA approval Posted 13/02/2015

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s), determined not to lose out on US Food and Drug Administration (FDA) approval for its generic version of the acid-reflux blockbuster Nexium (esomeprazole), is considering switching manufacturing to a new facility.

Dr Reddy’s currently manufactures an esomeprazole generic at a facility in India’s Srikakulam district but concerns have been raised by FDA following an inspection of the site, according to a report in the Indian news service DNA India.

The US regulatory agency issued Dr Reddy’s with a so-called Form 483. Companies that receive this form should respond to FDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what FDA requires.

The company is eager not to go the same way as fellow Indian generics company Ranbaxy, which lost FDA approval for its generic esomeprazole in 2014 [1]. It was an expensive loss for Ranbaxy, since annual sales of the drug are approximately US$6 billion in the US, according to IMS data in November 2014.

Although Dr Reddy’s has reportedly addressed the issues raised in FDA’s Form 483, a switch to a new manufacturing site would avoid any further controversy.

The company had received nine inspectional observations from FDA after their visit to the site in the Srikakulam district. These observations largely relate to procedural and other compliances of the plant systems, the company said in November 2014.

According to the DNA India report, the company has comprehensively responded to the Form 483. ‘The API [active pharmaceutical ingredients] for Nexium was from that facility and Nexium is a very big opportunity for the company,’ a pharma analyst told the news service, ‘However, an alternate plan is in progress so that the company may not have to lose out on this opportunity in case any unwanted development takes place.’

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1.   GaBI Online - Generics and Biosimilars Initiative. FDA revokes Ranbaxy’s esomeprazole and valganciclovir ANDAs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Generics/News/FDA-revokes-Ranbaxy-s-esomeprazole-and-valganciclovir-ANDAs 

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Source: DNA India

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