Novartis gets USFDA warning letter for two plants in India

Thursday, Oct 29, 2015

Sandoz, the generic drug arm of Swiss drug major Novartis, has received a warning letter from the US health regulator for violations of current good manufacturing practice (cGMP) norms at its two plants in Western India.

"On October 22, 2015, the US Food and Drug Administration (USFDA) issued a warning letter to our Sandoz Division concerning their Indian sites in Kalwe and Turbhe," Novartis AG said in its quarterly result statement.

Both Turbhe and Kalwe fall in Maharashtra.

The warning letter observations follow USFDA inspection at both sites in August 2014 and are related to deficiencies in current good manufacturing practice (cGMP) for finished pharmaceuticals, it added.

"The warning letter does not contain any new issues versus the 483 observations issued following the inspection in August 2014, which Sandoz has been addressing since then," the company said.

Sandoz will continue to work closely with the FDA to ensure all observations are resolved to the agency's full satisfaction, it added.

No supply disruptions are expected, the company noted.

At Turbhe, Sandoz mainly produces active pharmaceutical ingredients. In Kalwe oral solid dosages or tablets are produced.