Mumbai: Ranbaxy Laboratories Limited (RLL) has received tentative approval from the US Food and Drug Administration (US FDA) to manufacture and market Risperidone oral solution (1 mg/ml).
Risperdal (risperidone) oral solution, which is indicated for the treatment of schizophrenia, has total annual market sales of $66 million.
"We are pleased to receive this tentative approval for risperidone oral solution. This product represents a future opportunity for Ranbaxy and will be launched following final approval from the US FDA," said Jim Meehan, vice president of sales and marketing for RPI, US.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, US, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines. 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 as well as ground operations in 49 countries and manufacturing operations in eight countries.