Mumbai, Oct 16 : Pharmaceutical major Ranbaxy Laboratories today said it has received approval from Drug Controller General of India (DGCI) to initiate human clinical trials for its anti-malaria drug.
The Phase III clinical trial for its anti-malaria drug would be conducted on patients from India, Africa and South and South-east Asian nations, a company filing to the Bombay Stock Exchange said.
"Ranbaxy has successfully completed all the required regulatory safety and toxicity studies apart from a phase II clinical trial in India and Thailand with the drug candidate," the company said.
Further, the Indian drug maker is also planning to seek regulatory approval in countries outside India for the clinical trials of the drug.
"This is a landmark achievement for Ranbaxy's R&D (Research and Development) team," said Ranbaxy CEO and Managing Director Malvinder Mohan Singh adding "Ranbaxy's synthetic molecule will be safer and more effective than the existing drugs and will also have a clear cost advantage.
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