Granules India receives US FDA nod for depression treatment drug Trazodone

The Hyderabad-based company said that the US Food & Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA) for Trazodone Hydrochloride Tablets.

It is bioequivalent and therapeutically equivalent to the reference listed drug Desyrel Tablets of Pragma Pharmaceuticals, LLC.

Trazodone tablets are indicated for the treatment of major depressive disorder in adults.

The current annual U.S. market for Trazodone tablets is approximately $128 Million, according to MAT Jun 2024, IQVIA/IMS Health.

Dr. Krishna Prasad Chigurupati, chairman and managing director, Granules India, said: 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.

Granules now has 65 ANDA approvals from the US FDA (64 final approvals and 1 tentative approval).

Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).

The pharma company reported a consolidated net profit of Rs 134.65 crore in Q1 FY25, steeply higher than Rs 47.89 crore posted in Q1 FY24. Revenue from operations in first quarter of FY25 was at Rs 1,179.87 crore, up 19.72% from Rs 985.52 crore reported in the same period a year ago.

The scrip rose 0.90% to currently trade at Rs 658.30 on the BSE.

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