Sun Pharmaceutical Industries and its troubled US subsidiary, Caraco Pharmaceuticals, plan to together file 30 Abbreviated New Drug Applications with the US Food and Drug Administration (FDA) to market generic drugs, despite regulatory issues for the US company.
Between Sun and Caraco, 111 products are pending for approval with the USFDA at the end of June 2009, Dilip Shanghvi, chairman and managing director of Sun Pharma told the annual general meeting of the company in Vadodara last week.
Caraco is working with the USFDA to resolve all the problems as soon as possible, he said.
“Factories in Sun Pharma remained fully complaint with USFDA and current good manufacturing practices (cGMP) requirements. We continue to spend for product development and file new products from these sites in India and the US,” said Shanghvi.
Sun Pharma today filed a copy of Shanghvi's speech delivered at the AGM on September 11.
In June 2009, US marshals had raided Caraco's manufacturing facilities in the state of Michigan, at Detroit, Farmington Hills, and Wixom. Up to 33 different drugs were seized by the US marshals and the FDA banned Caraco from manufacturing and selling these drugs in the US, until there was assurance that the firm complies with manufacturing standards. The action came after Caraco's continued failure to meet the FDA's cGMP requirements.
Shanghvi said on account of the issues with Caraco, the company has decided not to give any revenue prediction for the year. Sun Pharma, which earns over 10 per cent of its turnover from business with Caraco, holds a 76 per cent stake in the company.
