Biophore and its subsidiary, Zenara Pharma, receive the first approval for Cannabidiol in India
100% Made-in-India including the active ingredient
Manufactured in US FDA and EU-approved facility in India
Indicated for the treatment of neuro disorders
Delhi NCR (India), May 16: Biophore India Pharmaceuticals has announced that it has received CDSCO approval for manufacturing and marketing of Cannabidiol active ingredient in India and 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.
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
Dr. Jagadeesh Babu Rangisetty, CEO at Biophore, says, “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 program 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 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 is already approved in the US for these indications, and this approval in India is expected to bring global treatment options within reach of Indian patients.
Dr Rangisetty adds, “It is the first time that such a product has been approved in the country, and we are proud to have played a part in it. The approval process during the last few months was exhaustive, and we thank the DCGI, CDSCO & Dr Vinod K Paul (Member, NITI Aayog) for their valuable inputs and collaboration. We are now preparing for the launch of this product by collaborating with a few like-minded organizations within India, including the largest manufacturer in the country, Akums Drugs & Pharmaceuticals Ltd.”
Biophore has informed 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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