HYDERABAD: Hyderabad-based Biophore India Pharmaceuticals has announced that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) for manufacturing and marketing a cannabidiol active ingredient in India. This is the first time that a cannabidiol-based product has been approved in India.
Its subsidiary Zenara Pharma has received the approval for the final product, cannabidiol oral solution 100mg/ml, for neuro disorders. Its manufacturing facilities are in Hyderabad and Visakhapatnam.
Cannabidiol has been developed by Zenara and Biophore from a synthetic route. It has been filed with the US FDA and is awaiting approval.
“Development of the product has been the result of an intense journey and relentless pursuit spread over some years," said Dr Jagadeesh Babu Rangisetty, chief executive officer, Biophore.
The approval received is for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis, a release said here on Sunday.
