A generic version of Abraxane withdrawn from the Indian market

Albupax was initially launched on the Indian market in September 2008 by Natco Pharma, an Indian pharmaceutical company.  Albupax is a generic version of the nanotechnology-based Abraxane drug by US company Abraxis BioScience, distributed in India through Biocon ; Abraxane is costlier than the Natco version by around Rs 5,000 per vial.

Three months ago, Abraxis Bioscience filed a written complaint citing serious side-effects that the generic may cause, which prompted the Drug Controller General of India (DCGI) to order fresh tests on Albupax. These tests showed at least a too high endotoxin content in Albupax – chloroform levels having also to be tested. The drug could then have the potential to cause liver damage ; the Indian drug regulatory authorities therefore asked Natco Pharma to recall Albupax from the market and to stop the production of the drug till investigations are over. A Natco spokesman, while confirming that the company has suspended production of the drug, underlined that “the testing procedures for nanotechnology-based products are complex“.  (article from 18/07/2009)

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