Shares of Granules India Ltd. rose by nearly 2% to touch a day’s high of Rs 666.30 on 9th August after the USFDA approved its Abbreviated New Drug Application for Trazodone Hydrochloride Tablets (USP).

Trazodone tablets are prescribed for treating major depressive disorders in adults.

In a stock exchange filing, Granules India Ltd. announced that the USFDA approved Trazodone Hydrochloride Tablets USP in 50 mg, 100 mg, 150 mg, and 300 mg dosages, which are bioequivalent and therapeutically equivalent to Desyrel Tablets of the same strengths by Pragma Pharmaceuticals, LLC.

The drug has an annual market value of approximately $128 million in the United States, based on data from MAT Jun 2024, IQVIA/IMS Health.

Granules India currently holds 65 ANDA approvals from the USFDA, including 64 final approvals and one tentative approval.

Krishna Prasad Chigurupati, Chairman and Managing Director of the company, said, “The approval in such a short span of 10 months from filing has once again showcased their robust R&D capability.” He added that the launch of the product was planned for this quarter and would gain market share in the succeeding few quarters.

In the first quarter of FY25, Granules India’s net profit rose to Rs 135 crore, up from Rs 48 crore in the same period last year.

Revenue grew by 19.7% to Rs 1,179.8 crore, with EBITDA surging nearly 90% to Rs 259.2 crore and margins expanding from 14% to 22%.

Net debt rose to Rs 842.1 crore at the end of FY24, up from Rs 767.1 crore in FY23. New products contributed 25% to the topline in the previous fiscal year, up from 16% in FY23.

At 3:30 PM, the shares of Granules India Ltd. closed 1% higher at Rs 659 on BSE.

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