subject: U.S drug regulator: Warns Sun Pharma [print this page] The United States Food and Drug Administration (USFDA) has issued a warning letter to Sun Pharmaceuticals as the company was found violating manufacturing norms in its Cranbury facility in New Jersey. Sun Pharma has stated that the FDA has withheld approval of pending new drug applications listing the facility as the manufacturer.
However, it is improbable that the decision may have a noteworthy impact on Sun Pharma's operations in the United States. The company's Cranbury plant manufacturers a restricted number of products - primarily four or five controlled substance drugs (or drugs that fall under the narcotics category). A Sun Pharma spokesperson informed that the profit impact would only be in "single-digit million dollars".
Sun Pharma sustained its 2010-11 consolidated sales growth expectation of 18-20 percent over the reported sales of 2009-10.
Ranjit Kapadia, vice-president of institutional research at HDFC Securities said, "The decision of FDA may not have much impact Sun Pharma in terms of revenue, but the sentiment of a warning letter may pull down stocks, in the wake of ongoing manufacturing issues for Caraco,"
Last year in June, Sun Pharma's U.S. subsidiary Caraco's Michigan facilities in Detroit, Farmington Hills, and Wixom were searched by U.S. marshals. The production had to be stopped for alleged violation of manufacturing regulations. The matter has not been resolved and the production is yet to be started.
Sun Pharmaceutical Industries Inc (SPI Inc) is a wholly owned subsidiary of Sun Pharma. The company received the warning letter by the USFDA as a follow-up to the earlier examination of their manufacturing facility in Cranbury which started in February. FDA found current Good Manufacturing Practice (cGMP) regulations were being violated, as per a statement.
"SPI Inc has undertaken immediate corrective actions and intends to respond promptly and timely to the USFDA within 15 working days," said Sun Pharma.
Besides an active ingredient facility, the company has three manufacturing facilities in the U.S. However, most of its supply to the US market is from its FDA-approved Indian manufacturing facilities.
Two years ago, Daiichi Sankyo-owned Ranbaxy Laboratories was also banned by FDA for violating manufacturing norms at two facilities in India. Ranbaxy is yet to receive approval from the regulator.
