Biophore India Pharmaceuticals, a Hyderabad-based company, has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market Cannabidiol active ingredient in India. This approval is a significant milestone as it represents the first approval of a Cannabidiol-based product in India, offering a unique therapy option for patients.
The CDSCO has granted approval to Biophore’s subsidiary, Zenara Pharma, for the final product, Cannabidiol Oral Solution 100mg/ml, used for neuro disorders. Zenara and Biophore developed the active ingredient through a synthetic route, and the same product has been filed with the US FDA, currently awaiting approval. The active ingredient was registered with the US FDA last year.
Manufacturing of the product takes place at state-of-the-art facilities in Hyderabad and Vishakapatnam, which are approved by the US FDA and EU, as stated by Biophore. The current approval is specifically for treating seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients aged one year or older.
Dr. Jagadeesh Babu Rangisetty, CEO of Biophore, expressed his excitement about the product’s approval, stating that it aligns with their vision of introducing world-class products to the Indian market. The development program for both the active ingredient and the final product has been an intense journey, and they are eager to move forward with the green light received.
Cannabidiol is already approved in the US for these indications, and the approval in India is expected to expand treatment options for Indian patients globally. Biophore plans to finalize collaboration agreements with Akums and other established corporates active in this segment, aiming to launch the product within the next four months.
In conclusion, the approval of Cannabidiol Oral Solution 100mg/ml is a significant milestone in the pharmaceutical industry, particularly in India where the use of Cannabidiol-based products has been limited. This approval provides a unique therapy option for patients with neuro disorders and is anticipated to expand global treatment options for Indian patients.
If your company is seeking CDSCO certification for its products, you can contact Indian Nexus for assistance. Indian Nexus is a leading consultant that specializes in helping companies obtain CDSCO certification effortlessly. They possess a team of experienced professionals who can guide you throughout the entire process and ensure that your products meet all the necessary requirements.
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