Granules India Receives US FDA approval For Trazodone tablets

Granules India Limited, an Indian pharmaceutical company experiencing rapid growth through vertical integration, reported that the US FDA has granted approval for its ANDA for trazodone hydrochloride tablets USP in various strengths. It has the same effectiveness and therapeutic value as the reference drug Desyrel tablets in various strengths from 50 mg to 300 mg, made by Pragma Pharmaceuticals, LLC.

Trazodone tablets are prescribed for treating major depressive disorder in adults.

Dr Krishna Prasad Chigurupati, chairman and managing director, Granules India Limited 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 has obtained 65 approvals from the US FDA, including 64 final approvals and 1 tentative approval. The Trazodone tablet market in the US is worth around $128 million annually, as reported in MAT Jun 2024 by IQVIA/IMS Health.

Founded in 1991, Granules India Limited is a rapidly expanding Indian pharmaceutical firm based in Hyderabad. It is vertically integrated with top-notch facilities and a strong focus on operational excellence, quality, and customer service.