Drug-maker Sun Pharmaceutical has said that it has resolved regulatory issues to do with its Cranbury plant, in the United States.
In a statement to the Bombay Stock Exchange, Sun said: “the US Food and Drug Administration has informed Sun Pharmaceutical Industries, Inc., its wholly owned subsidiary, that after a June 2011 re-inspection of its Cranbury, New Jersey, US, manufacturing facility, the site has an acceptable regulatory status. Therefore, the issues noted in the August 25, 2010, warning letter are considered to be resolved.”
The regulatory sword, however, continues to hang over Sun’s Detroit plant that comes under Caraco, a wholly owned subsidiary. “Caraco, now wholly owned by Sun Pharma, continues to work with consultants to resolve the issues raised by the USFDA at its Detroit plant,” the company said.
Last year, when the warning letter had been sent regarding the Cranbury plant, Sun Pharma had said that the regulator’s letter had followed an earlier inspection of the manufacturing facility initiated, in Feb 2010. During that inspection the USFDA had identified violations of current Good Manufacturing Practice regulations, the company had said.
Further, it even maintained its 2010-11 consolidated sales growth guidance, adding that SPI Inc had undertaken immediate corrective actions.
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