Granules India Limited Announces ANDA Approval for Trazodone Tablets

On August 9 2024, Granules India Limited announced that it had received approval from the US Food & Drug Administration (US FDA) for its generic version of Trazodone Hydrochloride Tablets USP in 50 mg, 100 mg, 150 mg, and 300 mg doses.

Trazodone tablets are bioequivalent and therapeutically equivalent to the reference drug Desyrel Tablets from Pragma Pharmaceuticals, LLC. Trazodone tablets are used to treat major depression in adults.

Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, 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, including 64 final and 1 tentative approval. The US market for Trazodone tablets is about $128 million annually, based on MAT June 2024 data from IQVIA/IMS Health.

Financial Highlights

Granules India reported its profit after tax (PAT) nearly tripled to ₹135 crore for the first quarter ending June 30, 2024, compared to ₹48 crore in the same period last year. Revenue from operations increased to ₹1,180 crore for the quarter, up from ₹985 crore a year earlier. With their strong quarterly results, the company is back on track after facing some challenges last year. The first-quarter performance underscores ongoing growth in the formulation segment, a strong North American business, and successful product diversification.

About Granules India Limited

Granules India Limited, founded in 1991, is a fast-growing Indian pharmaceutical company based in Hyderabad. The company operates with high-quality standards and is involved in the full manufacturing process, from Active Pharmaceutical Ingredients (APIs) to finished dosage forms. Granules serves over 300 customers in over 80 countries and has offices in India, the US, and the UK. It has 10 manufacturing facilities, with 8 in India and 2 in the US, and holds regulatory approvals from various global agencies, including the US FDA, EU GMP, and WHO GMP.

On August 9, 2024, the share price of Granules India Limited opened at ₹657.80, touching the day’s high at ₹665.95, as of 11:56 AM on the NSE.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.