This Article is From Nov 18, 2015

Taken Remedial Actions at Two Plants in Maharashtra: Novartis

Taken Remedial Actions at Two Plants in Maharashtra: Novartis
New Delhi: Drug firm Novartis on Tuesday said it has taken remedial action at its two plants in Western India which had received a warning letter from the US health regulator and expects the manufacturing facility to returm to normal functioning soon.

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

"Two Sandoz plants have received a warning letter from US Food and Drug Administration (USFDA). We have already taken remedial action at these plants and these units would be soon back to normal," Novartis India Managing Director and Vice Chairman, Ranjit Shahani told PTI on the sidelines of an event here.

On October 22, 2015, the USFDA had issued a warning letter to the company's Sandoz Division concerning Indian sites in Kalwe and Turbhe.

Both Turbhe and Kalwe fall in Maharashtra.

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

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

Novartis India shares today ended at Rs 848 a piece on the BSE, down 1.62 per cent from previous close.
 
.