Granules India Ltd shares gained 2.12% to hit an all-time high of ₹666.3 apiece on BSE on Friday, August 9, after the US Food and Drug Administration (USFDA) approved its Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets USP.

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

In a stock exchange filing, the company said the approvals have been granted for dosages of 50 mg, 100 mg, 150 mg, and 300 mg. Trazodone Hydrochloride Tablets USP is a bio and therapeutically equivalent to the reference listed drug, Desyrel Tablets, 50 mg, 100 mg, 150 mg, and 300 mg, of Pragma Pharmaceuticals, LLC.

The drug has an annual market of around $128 million in the United States, according to MAT Jun 2024, IQVIA/IMS health.

Granules India currently has 65 ANDA approvals from the US FDA (64 final approvals and one tentative approval).

The company’s chairman and managing director Krishna Prasad Chigurupati, said, “We received approval within 10 months of filing the application, which demonstrates our strong R&D capabilities. The product will be launched within this quarter, and the market share will gradually increase over the next few quarters.”

In the first quarter of FY25, Granules India’s net profit increased to ₹135 crore against ₹48 crore in the year-ago period.

Revenue climbed by 19.7% to ₹1,179.8 crore with Earnings Before Interest, Tax, Depreciation, and Amortization (EBITDA) increasing by nearly 90% to ₹259.2 crore and margins widening by 800 basis points to 22% from 14% last year.

The company’s net debt at the end of financial year 2024 was ₹842.1 crore, up from ₹767.1 crore in FY23.

The contribution of new items to the topline has also increased significantly, reaching 25% at the end of the previous fiscal year from 16% in fiscal year 2023.

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