It seems that Ranbaxy Pharmaceuticals (Ranbaxy) is not the only Indian generics manufacturer who has been subjected to FDA recalls. It now comes to light that Dr Reddy’s Laboratories (Dr Reddy’s) and Aurobindo Pharma (Aurobindo) have also had to recall key generic drugs during 2012.
In September 2012, FDA made Dr Reddy’s recall a batch of quetiapine fumarate, which is its version of AstraZeneca’s schizophrenia blockbuster Seroquel, which had sales revenues of US$4.6 billion in the US market for the year ended December 2011. Dr Reddy’s launched the generic drug in March 2012 following FDA approval. However, in September 2012 the generic 25 mg tablets were recalled due to failed dissolution test requirements.
The recall referred to only one particular lot (C203090 expiry 03/2014), however, a company representative told The Business Standard that ‘this was something that happened in September 2012. It was a very small batch and has no significance what so ever on Dr Reddy’s sales of quetiapine fumarate tablets in the US market.’
Dr Reddy’s has reportedly also had manufacturing issues with other products. It had an import ban on a plant in Mexico lifted only in July 2012.
An enforcement report brought out by FDA on 14 November 2012 also shows India-based Aurobindo voluntarily recalled a batch of its generic of sanofi-aventis’s insomnia treatment Ambien (zolpidem) from the US market in March 2012.
According to the FDA enforcement report, the zolpidem batch was recalled because of ‘adulterated presence of foreign tablets’. The FDA enforcement report said, ‘this product is being recalled because 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labelled Zolpidem Tartrate tablets USP 10.' The recall, however, was described as just a ‘labelling discrepancy’ and not ‘very serious’. FDA did, however, stop import of products from the company’s unit-3 facility and only resumed approving products from Aurobindo’s unit-3 in June 2012 following its inspection in March 2012.
The recalls are bad news for the generics industry as a whole, and especially for Indian manufacturers. Coupled with manufacturing violations and FDA-imposed import bans, the recalls reflect badly on Indian generics makers and call into question the quality of Indian generics.
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Source: Business Standard
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