Granules India Limited announced today that the US Food & Drug Administration (FDA) has approved its Abbreviated New Drug Application for Trazodone Hydrochloride Tablets USP in 50 mg, 100 mg, 150 mg, and 300 mg strengths. The tablets are bioequivalent to Pragma Pharmaceuticals’ Desyrel Tablets and are indicated for treating major depressive disorder in adults.
The shares of Granules India Limited were trading at ₹664.45, up by 11.60 points (1.78 per cent), on the NSE at 12:30 on Friday.
Dr Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, stated, “We have received the approval within 10 months of filing the application, which is a testament to our strong R&D capabilities. The product will be launched within this quarter, and the market share will grow steadily over the next few quarters.”
This approval brings Granules’ total FDA approvals to 65, including 64 final approvals and one tentative approval. The current annual US market for Trazodone tablets is approximately $128 Million, according to MAT Jun 2024 data from IQVIA/IMS Health.