Biophore India Pharma gets CDSCO nod to manufacture, market Cannabidiol in India
Cannabidiol by Zenara and Biophore has been filed with the USFDA and is awaiting approval.
Hyderabad: Biophore India Pharmaceuticals on Monday announced that it has received approval from the Central Drugs Standard Control Organisation(CDSCO) for the manufacturing and marketing of Cannabidiol in India. Cannabidiol or CBD, is the active ingredient in the cannabis or hemp plant, and some form of CBD is used for therapeutic purposes for certain medical conditions.
A press release from the drug maker said its subsidiary Zenara Pharma has received approval for the final product, Cannabidiol Oral Solution 100mg/ml for use in neurological disorders.
The approval currently received is for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex in patients 1 year of age or older.
Cannabidiol by Zenara and Biophore has been filed with the USFDA and is awaiting approval.
This is the first time ever that a Cannabidiol-based product has been approved in India delivering a unique therapy option. The product is being manufactured at USFDA and EU approved state-of-the-art facilities in Hyderabad and Vishakhapatnam, it said.
Jagadeesh Babu Rangisetty, CEO, Biophore, said, "The approval of this product is in line with our vision to bring world-class products to the Indian market. It has been an intense journey over the past few years on the development programme of this product, both the active ingredient and the final product, and we are really excited to get the green light. We continue to invest in such first-of-its-kind products for the Indian market and we will see more of such in the coming years."
The therapeutic areas Zenera Pharma focuses on include Anti-virals, Neurology, Women’s health, Cardiology, Imaging, and Contrast Agents among others.
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