Jubilant Life Sciences Ltd, a global pharmaceutical and life sciences company, has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (US FDA) for quetiapine fumarate tablet 25 mg (base), the generic version of AstraZeneca's Seroquel, which is an atypical antipsychotic medication indicated for the treatment of schizophrenia, and for the treatment of acute manic episodes associated with bipolar disorder.
The current total market size for this product as per IMS is US$ 59 million per annum. We expect to launch this product in Q4 FY14.
As on September 30, 2013, Jubilant Life Sciences had a total of 676 filings for formulations of which 218 have been approved in various regions of the world. This includes 58 ANDAs filings in the US and 48 dossier filings in Europe.
Jubilant Life Sciences Limited is engaged in manufacture and supply of APIs, generics, speciality pharmaceuticals and life science ingredients.