Biophore and its subsidiary, Zenara Pharma, receive the first approval for Cannabidiol in India

Read Time:2 Minute, 18 Second

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

If you have any objection to this press release content, kindly contact pr.error.rectification[at]gmail.com to notify us. We will respond and rectify the situation in the next 24 hours.

The post Biophore and its subsidiary, Zenara Pharma, receive the first approval for Cannabidiol in India appeared first on Republic News Today.

Related Posts

RCS and Google Wallet services launch on L&T Metro Rail Hyderabad Ltd

New Delhi [India] November 8: Powered by Billeasy and Route Mobile, L&T Hyderabad Metro commuters will now be able to book Digi-Tickets from RCS and store them directly on Google…

Photoquip’s Nanlite and Nanlux Lighting Captivate at Broadcast India Show 2024

Mumbai (Maharastra) [India],November 8: Photoquip, one of India’s premier lighting innovators, made waves at this year’s Broadcast India (BI) 2024 show with its high-performance Nanlite and Nanlux lighting solutions, solidifying…

You Missed

Acclaimed author Berjis Desai unveils tense crime thriller,Murder at the Racecours

  • By
  • November 7, 2024
Acclaimed author Berjis Desai unveils tense crime thriller,Murder at the Racecours

REHAU Celebrates the Grand Opening of First Experience Centre in Noida

REHAU Celebrates the Grand Opening of First Experience Centre in Noida

Neisa Kolakhe Crowned Mrs. Femme International 2024 at Mrs. India Inc Season 5 Grand Finale

  • By
  • November 4, 2024
Neisa Kolakhe Crowned Mrs. Femme International 2024 at Mrs. India Inc Season 5 Grand Finale

Aanchal Saini Wins Miss Urvashi 2024, Mahvish Khan is First Runner-up, Mamta Khinchi Second Runner-up

  • By
  • October 29, 2024
Aanchal Saini Wins Miss Urvashi 2024, Mahvish Khan is First Runner-up, Mamta Khinchi Second Runner-up

Digital house hunting- A rising and pathbreaking trend of 2024

  • By
  • October 29, 2024
Digital house hunting- A rising and pathbreaking trend of 2024

How New Holistic Companies Preserving Ancient Vedic Practices

  • By
  • October 26, 2024
How New Holistic Companies Preserving Ancient Vedic Practices