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