Biophore India Pharmaceuticals has announced that it has received CDSCO approval for manufacturing and marketing of Cannabidiol active ingredient in the domestic market.
It’s subsidiary, Zenara Pharma, has received the approval for the final product, Cannabidiol Oral Solution for neuro disorders.
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 US FDA and EU-approved state-of-the-art facilities in Hyderabad and Vishakapatnam.
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Cannabidiol has been developed by Zenara and Biophore completely from a synthetic route and the same product has been filed with the US FDA as well and awaiting approval. The active ingredient has already been registered with the US FDA last year.
“The approval of this product is in line with our vision to bring world-class products to the Indian market,” Jagadeesh Babu Rangisetty, CEO, Biophore, said, adding, “It has been an intense journey over the past few years on the development program of this product, both the active ingredient and the final product, and we are really excited to get the green light.”
The approval currently received is for the treatment of seizures associated with Lennox-Gastuat syndrome, Dravet syndrome or tuberous sclerosis complex in patients 1 year of age or older.
Cannabidiol is already approved in the US for these indications and this approval in India is expected to bring global treatment options within reach of the Indian patients, the company said.