Granules India Secures USFDA Approval For Trazodone Tablets

Granules India received the approval for its Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets by the US Food & Drug Administration (US FDA). 

The company in a press statement on Friday informed that the approval covers Trazodone tablets in 50 mg, 100 mg, 150 mg, and 300 mg dosages, making them bioequivalent and therapeutically equivalent to Pragma Pharmaceuticals, LLC's Desyrel Tablets in the same strengths.

Trazodone tablets are prescribed for the treatment of major depressive disorder in adults. Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, highlighted the swift approval process, achieved within 10 months of application, as a testament to the company's robust R&D capabilities. He also indicated that the product will be launched within this quarter, with expectations of steady market share growth in the coming months.

With this latest approval, Granules India now holds 65 ANDA approvals from the US FDA, comprising 64 final approvals and 1 tentative approval. The current annual market for Trazodone tablets in the U.S. is approximately USD 128 million, according to MAT June 2024 data from IQVIA/IMS Health.