
USFDA9 Aug 2024, 05:21 pm
Granules India Receives US FDA Approval for Trazodone Tablets, Market Size $128 Million
AI Summary
Granules India Limited announced on 9 August 2024 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. The product will be launched within this quarter and the market share is expected to grow steadily over the next few quarters. The current annual U.S. 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 with best-in-class facilities and a commitment to operational excellence, quality, and customer service.
Key Highlights
- US FDA approval for Trazodone Hydrochloride Tablets USP
- Product launch within this quarter
- Expected growth in market share over the next few quarters
- Current annual U.S. market for Trazodone tablets is approximately $128 Million
- Granules India Limited is a vertically integrated fast-growing Indian pharmaceutical company