Sun Pharmaceuticals today said its American subsidiary Caraco has received an approval from the US health regulator for a work plan, which could pave way for resuming production at its Michigan facilities, almost a year after they were shut.
In June 2009, the US Food and Drug Administration (USFDA) had seized drugs from the Michigan facilities of Caraco and stopped the firm from further distributing them, until the company complied with good manufacturing requirements.
The company was pulled up for repeated violation of the USFDA's manufacturing standards.
"We have received an approval for a work plan submitted to the USFDA covering remedial actions," Sun Pharmaceuticals Chairman and Managing Director Dilip Shanghvi said.
The development would lead to resuming manufacturing at the Michigan facilities, he added.
Following the issues with the USFDA, Caraco reported a net loss of $9 million for the fiscal year 2009-10.
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Commenting on the overall outlook for Sun Pharma in the on-going fiscal Shanghvi said, net sales is likely to grow by 18-20 per cent and investment on R&D would increase to 7-8 per cent of the net sales.
For the year ended March 31, 2010, the company had reported a net sales of Rs 4,103 crore.