US FDA issues warning to Sun Pharma's US manufacturing unit

Sun Pharmaceutical Industries Inc (SPI Inc), the US-based unit of the company, has received a warning letter from the US Food and Drug Administration (FDA) for violation of good manufacturing practices (GMP) regulations, the company said in a statement today.

The FDA's letter was issued as a follow-up to an inspection in February, 2010, during which the US drug regulator had identified violations of GMP regulations, it said.

In response to the warning letter, the company said, "SPI has undertaken immediate corrective actions."

"SPI Inc intends to respond promptly and timely to the US FDA within fifteen working days. SPI Inc is committed to working cooperatively and expeditiously with the US FDA to resolve the matters indicated in its letter," the company said.

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