Granules India Receives FDA Approval for Trazodone Tablets; Reports Strong Financial Growth in Q1 FY25

Tablets containing trazodone are recommended for the treatment of serious depressive illness in adults.The business said in a stock market filing that the doses of 50 mg, 100 mg, 150 mg, and 300 mg had been approved. The reference stated medication, Pragma Pharmaceuticals, LLC's Desyrel Tablets, 50 mg, 100 mg, 150 mg, and 300 mg, is bio and therapeutically comparable to Trazodone Hydrochloride Tablets USP.

As per IQVIA/IMS health's MAT Jun 2024 report, the drug's annual market size in the United States is around $128 million.Granules India presently holds 65 US FDA ANDA clearances (one tentative approval and 64 final approvals).

Krishna Prasad Chigurupati, the chairman and managing director of the firm, stated: "Our strong R&D capabilities are demonstrated by the fact that we received approval within 10 months of filing the application." This quarter will see the product's introduction, and over the next several quarters, the market share will progressively rise.

Granules India's net profit climbed to ₹135 crore in the first quarter of FY25 from ₹48 crore in the same time the previous year.Earnings Before Interest, Tax, Depreciation, and Amortisation (EBITDA) increased by over 90% to ₹259.2 crore, while margins widened by 800 basis points to 22% from 14% last year. Revenue increased by 19.7% to ₹1,179.8 crore.Net debt for the firm increased from ₹767.1 crore in FY23 to ₹842.1 crore at the end of the fiscal year 2024.