AMRI adds non-GMP capacity to Indian plant
The move adds 1,000 litre-scale, non-good manufacturing practice (GMP) production capacity to the facility’s offering and will serve as a extension to AMRI’s existing 100 litre manufacturing laboratory in Hyderabad.
AMRI’s expansion is in keeping with India’s transformation from a provider of low-cost manufacturing capacity to a hub for drug development and clinical trials. According to a recent report by KPMG the Indian trial sector, which was worth $200m (€157.7m) in 2007, will generate between $500-600m by 2010, equivalent to 15 per cent of the global market.
The report attributes the growth to India’s position as one of the lowest cost clinical trial markets, equalled only by Russia, and its high level of patient recruitment rates, according to data released this year’s World Economic Forum meeting.
Commenting on the Aurangabad expansion D’Ambra said: “We are pleased to offer another high-value alternative to our customers seeking the cost benefit of doing business in Asia, but retaining the quality they expect from a US based-organization.”
He added that: “Separately, we look forward to realising cost savings at our US manufacturing operations by becoming our own provider for some raw materials, eliminating third party costs in both money and lead time.”
Andrea Schultz, spokeswoman for AMRI explained that the Aurangabad plant will produce starting materials and intermediates used in drug development, including early stage clinical trials.
She added that some of its new capacity would be used to make starting materials for its manufacturing facilities in both India and the US.