Biophore India Pharmaceuticals Receives CDSCO Approval for Cannabidiol-Based Treatment for Neuro Disorders
Delhi NCR, India – May 16, 2025 – Biophore India Pharmaceuticals has made a significant stride in the Indian pharmaceutical market by receiving CDSCO (Central Drugs Standard Control Organization) approval for manufacturing and marketing Cannabidiol (CBD) active ingredients in India. The company’s subsidiary, Zenara Pharma, has also received approval for its final product, the Cannabidiol Oral Solution 100mg/ml, intended for the treatment of neuro disorders. This marks the first time a Cannabidiol-based product has been approved in India, offering a unique therapeutic option for patients suffering from neuro disorders.
Manufactured in India’s US FDA and EU-Approved Facilities
The Cannabidiol Oral Solution is being produced at state-of-the-art facilities in Hyderabad and Vishakapatnam, which are approved by both the US FDA and the EU. Both the active ingredient and the final product were developed entirely through a synthetic route by Zenara and Biophore. Additionally, the active ingredient has already been registered with the US FDA, and the product itself is awaiting approval in the United States.
A Game-Changer for Neuro Disorder Treatment in India
The product has received approval for treating seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients aged 1 year or older. Cannabidiol is already approved in the US for these indications, and its approval in India is expected to provide new global treatment options to Indian patients, bridging a significant gap in the availability of effective therapies.
Biophore’s Vision for the Indian Market
Dr. Jagadeesh Babu Rangisetty, CEO of Biophore, expressed his excitement about the approval, stating, “The approval of this product aligns with our vision of bringing world-class products to the Indian market. The journey of developing both the active ingredient and the final product has been intense, and we are thrilled to see it come to fruition. We are committed to investing in innovative products for the Indian market, and this is just the beginning.”
Collaboration with Akums Drugs & Pharmaceuticals
Biophore has announced that it is preparing for the launch of the Cannabidiol Oral Solution by collaborating with several key organizations, including Akums Drugs & Pharmaceuticals Ltd., one of India’s largest pharmaceutical manufacturers. The collaboration agreements are expected to be finalized soon, and the product is targeted for launch within the next four months.
Dr. Rangisetty further stated, “It’s a milestone for the country, and we are proud to be part of this historic achievement. The approval process was rigorous, and we are grateful for the support and collaboration from the DCGI, CDSCO, and Dr. Vinod K Paul, Member of NITI Aayog. We are now focused on bringing this life-changing treatment to Indian patients.”
Rajneesh Singh is a journalist at Asian News, specializing in entertainment, culture, international affairs, and financial technology. With a keen eye for the latest trends and developments, he delivers fresh, insightful perspectives to his audience. Rajneesh’s passion for storytelling and thorough reporting has established him as a trusted voice in the industry.
