Biophore Subsidiary Zenara Pharma receive First Approval For Cannabidiol in India

Biophore India Pharmaceuticals announced on Monday that it has been approved by the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market Cannabidiol in India. Cannabidiol, or CBD, is the active ingredient in the cannabis or hemp plant, and some forms of CBD are used to treat medical conditions. The drugmaker's subsidiary Zenara Pharma received approval for the final product, Cannabidiol Oral Solution 100mg/ml, for use in neurological disorders, according to a press release.

The current approval is for the treatment of seizures caused by Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients aged one year or older. Zenara and Biophore's Cannabidiol has been submitted to the USFDA and is awaiting approval. This is the first time in India that a Cannabidiol-based product has been approved, providing a novel therapy option. According to the company, the product is manufactured at USFDA and EU-approved state-of-the-art facilities in Hyderabad and Vishakhapatnam. 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."