Bangalore, Sep 02, 2010: In a move that could impact future approvals of some of its new drug applications in the US, Sun Pharmaceutical Industries (SPI Inc), a wholly-owned subsidiary of India-based Sun Pharma, an integrated pharma company, has said that it has received a warning letter from the US Food and Drug Administration (US FDA).

 

“This letter was issued by the US FDA as a follow up to the last inspection of the SPI Inc manufacturing facility in Cranbury, New Jersey, US, initiated in February 2010, during which the US FDA had identified violations of current good manufacturing practice (cGMP) regulations. SPI Inc has undertaken immediate corrective actions," a media release from Sun stated.

"SPI Inc intends to respond promptly to the US FDA within 15 working days. SPI Inc is committed to working cooperatively and expeditiously with the US FDA, to resolve the matters indicated in its letter," the release added.

 

Until the SPI Inc responses to the observations have been clarified and explanations provided to the satisfaction of the US FDA, the US FDA may, in the near term, withhold approval of pending new drug applications listing the facility as the manufacturer.

 

This is the second such incident involving a Sun Pharma subsidiary and the US FDA. In November 2008, Caraco Pharmaceuticals, another subsidiary of Sun Pharma, received a warning letter from the US FDA over the company's manufacturing facility in Detroit. This was on the inadequate and untimely investigation by the quality control unit, of certain incidents at the facility, contrary to the company's standard operating procedures.