Institute of Good Manufacturing Practices India
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US drug maker Mylan has sent a notice to Strides Arcolabs. Strides Arcolabs is an Indian pharmaceutical company, headquartered at Bangalore in southern India. The company manufactures pharmaceutical products, over-the-counter drugs and nutraceutical.
Mylan is seeking explanation over the Agila manufacturing plant and a possible compensation towards the remedial process sought by the US Food & Drug Administration, sources revealed.
The shares of the Bengaluru-based company fell sharply on Monday. Shares of Strides closed at Rs 1,278, down 4.7 per cent, Monday on the Bombay Stock Exchange (BSE).
Mylan acquired Strides's injectible facility, Agila, in 2013 for nearly $1.7 billion. Within a year, the US drug regulator sent a notice to Mylan about violations of good manufacturing practices. In a letter addressed to Mylan
CEO Rajiv Malik, the FDA said its inspection in August, October and March in 2014 found that the manufacturing units didn't make "sufficient corrective measures".
"Even without this Warning Letter, your corporate quality system should have detected and corrected the forgoing violations without FDA intervention," the FDA letter said.