A generic version of Abraxane withdrawn from the Indian market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)

[[[ Additional links suggested by Nanocolors :

# Nanoparticles in clinical trial trends : comments and focus on Abraxane

# Business rivalry may be a reason for Natco Albupax recalled ]]]

A new phase I clinical trial involving a nanoparticle formulation

The Indian subsidiary of Fresenius Kabi launched in March 2009 a new phase I clinical trial involving a nanoparticle formulation, which is now registered in the Clinicaltrials.gov database under reference NCT00915369. According to this page, “the main objectives of the study are to determine the pharmacokinetic profile of the drug at different dose levels in the patients with Advanced Breast Cancer. Maximum Tolerated Dose (MTD) and safety of Paclitaxel Nanoparticle will also be simultaneously assessed“.

Nanoshel Research Center blog

Nanoshel is an Indian company which makes single-walled, multi-walled and functionalized carbon nanotubes used in various industry sectors. The company blog – Nanoshel Research Center – is mostly dedicated to nanotube-related R&D (RSS feed).

Bangalore Nano 2008

The Bangalore Nano 2008 conference will take place in Bangalore (India) from December 11th till December 13th. The program is available here. Although a few experts from abroad are among the speakers, it is mostly a national event.

NanoDaddy.com, NanoIndian.com

NanoDaddy.com provides in the same place nanotechnology research news, business news, and event annoucements . NanoIndian seems to be a brother website with pretty much the same design and structure – and a focus on Indian nanotechnology news & events.