New Delhi: Leiutis Pharmaceuticals LLP has announced that the Central Drugs Standard Control Organisation (CDSCO) has granted regulatory approval to its collaboration partner Zenara Pharma to manufacture and market its proprietary Synthetic Cannabidiol Oral Solution 150 mg/mL for the management of mild to moderate anxiety disorders when used in conjunction with cognitive behavioural therapy (CBT). The product is to be prescribed only by psychiatrists.
This is the world’s first approved synthetic cannabidiol therapy for anxiety disorders, researched, developed, patented, and clinically validated entirely in India by Leiutis. Marketing approval is supported by the successful completion of a Phase III clinical trial in India and will be followed by a Phase IV study to further evaluate its safety and efficacy.
The product contains a fully synthetic cannabidiol (CBD) API, which has no abuse or dependence potential, distinguishing it from other psychoactive products. The API was developed by Biophore India Pharmaceuticals.
The drug product will be manufactured by Zenara at its CDSCO-, FDA-, and EU-compliant facilities.
Commenting on the approval, K. Chandrasekhar, CEO & Managing Partner, Leiutis Pharmaceuticals, said, we have been researching cannabinoids for about a decade, recognising their unique pharmacological potential. Over the years, we have made significant investments to understand these compounds, develop synthetic manufacturing processes for the active pharmaceutical ingredient (API), create our proprietary nano-dispersible drug delivery technology, and establish clinical efficacy through rigorous clinical research. This product has been developed entirely in India and is protected by patents in India and other key global markets.”
Dr. Jagadeesh B Rangisetty, CEO of Biophore India Pharmaceuticals said, “We are delighted to see years of dedicated research and innovation culminate in this important milestone. Our mission has always been to make a meaningful contribution to mental healthcare, and we believe this approval marks a significant step towards that goal. This is the first regulatory approval from our innovation pipeline, with several more candidates advancing towards clinical and regulatory milestones,” he added.
Dr. Sanjay Sharma, President – Corporate Strategy & Growth, Leiutis Pharmaceuticals, said, “We are excited about the approval of this innovative product and look forward to making it available to patients across India soon through psychiatrists and our collaborative network. We remain committed to expanding access to innovative therapies and advancing mental healthcare by providing prescribers and patients with new therapeutic options.”
The approval comes at a time when anxiety disorders remain a significant public-health challenge in India. The National Mental Health Survey 2015–16, conducted by NIMHANS across 12 states and various publications, reported a current prevalence of 2.57% and a lifetime prevalence of 3.5% for anxiety disorders among adults. These surveys and reports also identified treatment gaps across mental disorders ranging from 28% to 83%, underscoring the need for timely diagnosis, effective treatment and continuity of mental healthcare.
Key Highlights
- Manufactured using fully synthetic, well-characterised cannabidiol, with the active pharmaceutical ingredient (API) supported by a United States Drug Master File (US DMF), reflecting internationally accepted quality standards.
- Proprietary product designed using proprietary nanodispersible technology
- Expands treatment options for anxiety disorders, a condition affecting millions of Indians where treatment gaps remain as high as 83%.
About Leiutis Pharmaceuticals LLP
Leiutis Pharmaceuticals LLP is a speciality therapeutics company focused on developing medicines in neuropsychiatry and pain management through novel drug delivery technologies, and in oncology through its new chemical entity (NCE) programme.About Biophore India Pharmaceuticals
Biophore India Pharmaceuticals Pvt. Ltd., an associate company to Leiutis Pharmaceuticals LLP, is a research-driven API company which specialises in the complex active pharmaceutical ingredients for global pharmaceutical markets.
About Zenara Pharma
Zenara Pharma, a subsidiary of Biophore India Pharmaceuticals focuses on developing innovative therapies for rare and orphan diseases, as well as differentiated pharmaceutical products.
Disclaimer: This press release is intended for psychiatrists and medical professionals only. It is not intended for patients or the general public and should not be treated as promotional material for consumers.
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