Drugmaker Biophore India Pharmaceuticals has received Central Drugs Standard Control Organisation (CDSCO) approval for manufacturing and marketing of Cannabidiol active ingredient in India.
The company’s subsidiary Zenara Pharma has received approval for the final product, Cannabidiol Oral Solution 100mg/ml, indicated for neuro disorders.
It is for the first time that a Cannabidiol-based product has been approved in India. The product is being manufactured at U.S. FDA and EU approved state-of-the-art facilities in Hyderabad and Visakhapatnam. Preparations are underway for the launch of the product, in four months, by collaborating with like-minded organisations in India, including Akums Drugs & Pharmaceuticals, Biophore said.
Zenara and Biophore have developed Cannabidiol completely via synthetic route and the same product has been filed with the U.S. FDA for approval.
The active ingredient had already been registered with the U.S. FDA last year.
The CDSCO approval is for treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex in patients one year of age or older. Cannabidiol is already approved in the U.S. for these indications, the company said in a release.
“We continue to invest in such first-of-its-kind product for the Indian market and we will see more of them in the coming years,” Biophore CEO Jagadeesh Babu Rangisetty said.
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