Hyderabad: Hyderabad-based Biophore India Pharmaceuticals has announced that it has received approval from he Central Drugs Standard Control Organisation (CDSCO) for manufacturing and marketing of Cannabidiol active ingredient in India.
Its subsidiary, Zenara Pharma, has received the approval for the final product, Cannabidiol Oral Solution 100mg/ml, 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, Biophore said in a statement.
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. 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,” said Dr. Jagadeesh Babu Rangisetty, CEO, Biophore.
The approval currently 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 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.
Biophore has announced that they will soon be completing the collaboration agreements with Akums and other established corporates who are active in this segment and are targeting to launch the product in the next four months.
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