Ranbaxy gets TGA-Australia approval for SEBIFIN? Terbinafine Tablets

Ranbaxy Laboratories Limited (Ranbaxy) announced today that the Company has received an approval from the Therapeutic Goods Administration (TGA), Department of Health and Ageing, of the Australian Government, for the registration of SEBIFIN® Terbinafine Tablets in Australia.  

The marketing authorisation application was submitted by Ranbaxy Australia Pty Ltd., a wholly owned subsidiary of Ranbaxy.  This approval was based on the assessment by the TGA that the Ranbaxy formulation of Terbinafine is  bioequivalent to, and having the same  therapeutic effect as that of the reference listed product, Lamisil® Tablets of Novartis Pharmaceuticals Australia Pty Ltd, Australia.

With the approval of SEBIFIN®, Ranbaxy now has a total number of 26 molecules approved for marketing in Australia since the incorporation of Ranbaxy Australia in 2004.  These cover a wide range of therapeutic areas including anti-hypertensives, anti-infectives, hypolipidaemic agents, anti-convulsants, anti-depressants etc.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.