Granules India has announced that the US Food & Drug Administration (US 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.

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

Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Ltd., 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). The current annual U.S. market for Trazodone tablets is approximately USD 128 Million.

Granules India Ltd. 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.

The company is among the few pharmaceutical companies in the world to be present in the manufacturing of the entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). Their products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, the US, and the UK.