Ranbaxy Laboratories Ltd, India’s largest drug company, has submitted an investigational new drug (IND) application to the Drug Controller General of India for permission to initiate Phase-I human clinical trials, the company said in a statement today.
The IND application is for the respiratory inflammation that the joint GSK-Ranbaxy steering committee had identified earlier last year.
Ranbaxy has successfully completed all the required regulatory safety and toxicity studies on the drug candidate and also plans to seek regulatory approval in other countries outside India in order to initiate phase-I human clinical trials at the earliest.
