Granules India Limited, a vertically integrated fast-growing Indian pharmaceutical company, announced that the US Food & Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for trazodone hydrochloride tablets USP, 50 mg, 100 mg, 150 mg, and 300 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug, Desyrel tablets, 50 mg, 100 mg, 150 mg, and 300 mg, of Pragma Pharmaceuticals, LLC.
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.”
ANDA approvals- Granules now has 65 ANDA approvals from the US FDA (64 final approvals and 1 tentative approval).
US market for Trazodone- The current annual US market for Trazodone tablets is approximately $128 Million, according to MAT Jun 2024, IQVIA/IMS Health.
Granules India Limited, incorporated in 1991 is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and a commitment to operational excellence, quality, and customer service.