Jubilant Life Sciences receives ANDA approval

Jubilant Life Sciences, an integrated Pharmaceuticals and Life Sciences Company has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (USFDA) for Spironolactone Tablets, 25 mg, 50 mg and 100 mg, the generic version of Aldactone (of GD Searle), which is used as a diuretic to treat fluid retention (edema) caused by congestive heart failure and cirrhosis of the liver. The company is likely to launch this product in Q1 FY15. The total market size for Spironolactone Tablets as per IMS is $87 million per annum. Jubilant has also received a tentative approval from the USFDA for Memantine Tablets, 5 mg and 10 mg, the generic version of Namenda (of Forest Labs), which is used for treatment of moderate‐to‐severe Alzheimer’s disease. The company expects to launch this product post patent expiry in 2015. The total market size for Namenda as per IMS is $1.85 billion per annum. As on December 31, 2013, Jubilant Life Sciences had a total of 689 filings for formulations of which 230 have been approved in various regions globally. This includes 60 ANDAs filed in the US and 42Dossier filings in Europe. Jubilant Life Sciences is a global Pharmaceutical and Life Sciences Company engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Life Science Ingredients.