Jubilant Life Sciences Ltd announced today that it has received Abbreviated New Drug Application (ANDA) approval for pantoprazole sodium delayed release tablets 20mg and 40mg, a generic equivalent of Protonix a product of Wyeth, from the US FDA (US Food and Drug Administration).
Pantoprazole sodium tablets will be manufactured at the ‘state of the art’ dosage forms facility of Jubilant Life Sciences, at Roorkee, in India, with backward integration into the API manufactured at the Company’s US FDA approved API facility at Nanjangud in India. 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 USA were over US$ 1.46 billion as on March 2011, as per New Port Global Database.
Pantoprazole sodium tablets are indicated for the short-term treatment of erosive esophagitis associated with gastro esophageal reflux disease, maintenance of healing of erosive esophagitis and pathological hypersecretory conditions including Zollinger-Ellison Syndrome.
Jubilant Life Sciences Limited, is an integrated Pharma and Life Sciences Company. It is the largest Custom Research and Manufacturing Services (CRAMS) player and a leading Drug Discovery and Development Solution (DDDS) provider out of India. The Company provides Life Sciences products and services across the value chain. With 10 world-class manufacturing facilities and a team of 5800 multicultural people across the globe, the Company is committed to deliver value to its customers in over 75 countries.