Jubilant receives USFDA approval for Pantoprazole tablets

NEW DELHI: Jubilant Life Sciences on Wednesday said it has received the US health regulator's approval for the launch of Pantoprazole Delayed Release Tablets 20 mg and 40mg.

"Pantoprazole Sodium Tablets will be manufactured at Jubilant Life Sciences' facility at Roorkee with backward integration into the API manufactured at the company's USFDA approved API facility at Nanjangud in India," the company said in a statement.

USFDA has given an Abbreviated New Drug Application approval for the tablets used in the short-term treatment of erosive esophagitis associated with gastro esophageal reflux disease.

"The tablets are also used for maintenance of healing of erosive esophagitis and pathological hypersecretory conditions including Zollinger-Ellison Syndrome," the statement said.

The product will be marketed by its US subsidiary Jubilant Cadista Pharmaceuticals Inc under its own label.

The total sales of Pantoprazole Sodium tablets in the US were over USD 1.46 billion as on March 2011, as per New Port Global Database, it added.