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 OZIDAL Risperidone 0.5, 1, 2, 3 and 4 mg 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 Risperidone is bioequivalent to, and having the same therapeutic effect as, that of the reference listed product RISPERDAL® tablets of Janssen-Cilag Australia Pty Ltd, Australia.
With the approval of OZIDAL, Ranbaxy now has a total number of 27 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 globally. Ranbaxy’s continued focus on R&D has resulted in a significant number of approvals in developed markets and 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 novel 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. To date, it has ground operations in 49 countries and manufacturing operations in 11 countries.