Sun's US arm gets warning from FDA

MUMBAI: Sun Pharmaceutical���s US subsidiary, Caraco Pharmaceuticals, has received a warning letter from the US Food and Drug Administration (USFDA) over quality-control issues. The letter, which was issued on Friday, was a follow-up to the FDA inspection of Caraco���s manufacturing facility in Detroit in May.

The FDA may withhold approval of pending new drug applications of Caraco till the company satisfies the authority���s concerns. Caraco said on Tuesday it intends to respond to the FDA within 15 days. The company���s Detroit facility manufacturers generic drugs.

���This development does not affect Sun���s sales or approvals for ANDAs in the US. It also does not affect sales for Caraco but might cause a slowdown in approvals for it. However, we continue to sell successfully in the US,��� a Sun Pharma spokesman said.

Caraco said FDA had issued a notice in June 2008 following the inspection of the Detroit unit, which Caraco responded to within 30 days. ���Corrective actions were taken,��� Caraco said in a media statement.

A section of the domestic industry finds a design in Indian companies being penalised in the US market. Recently, USFDA had banned drugs which were produced at Ranbaxy���s two manufacturing plants in India. ���It looks like the US is targeting Indian companies. Other Indian companies may face similar problems in the future,��� an industry analyst said.The Sun Pharma stock slipped 4.7% to close at Rs 1,054.10 on BSE on Tuesday.