CHENNAI: Shares of Hyderabad-based drug maker Dr. Reddy's Laboratories Ltd. are in the spotlight today following a regulatory update from the US Food and Drug Administration (FDA) and the announcement of the company’s January–March quarter and full-year (2024–25) financial results.
As of 10:40 a.m. on Monday, the company’s shares were trading at ₹1,229.20 on the NSE, down 0.12%.
Regulatory Development
In a recent regulatory filing, the company—India’s sixth most valued drug maker in terms of market capitalisation—disclosed that the FDA issued a Form 483 with two observations following an inspection of its active pharmaceutical ingredient (API) facility in Middleburgh, New York. The inspection was conducted from May 12 to May 16, 2025.
“We have received a Form 483 with two observations, which we will address within the specified timeline,” the company stated in its stock exchange filing.
A Form 483 is issued at the conclusion of an FDA inspection when investigators observe any conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act. Such observations can lead to a temporary suspension of product distribution from the facility until the noted deficiencies are resolved to the regulator’s satisfaction. While the specific nature of the observations was not disclosed, the company’s assurance of timely remediation suggests that the issues are manageable, industry analysts say.
Financial Performance
Dr. Reddy’s reported robust financial results for the final quarter of the 2024–25 fiscal year, reflecting resilience and growth across its global operations. Consolidated net profit rose 22% year-on-year to ₹1,594 crore.
Revenue for the quarter stood at ₹8,506 crore, marking a 20% increase from ₹7,083 crore in the same period last year.
The board has recommended a final dividend of ₹8 per equity share (face value ₹1) for the 2024–25 financial year.
Management attributed the growth in revenue and profit to successful product launches, increased contributions from key products in the US, and the integration of the recently acquired NRT business.
Co-Chairman and Managing Director G.V. Prasad stated in the company’s earnings release that Dr. Reddy’s achieved double-digit growth across its businesses.
“We will continue to strengthen and grow our core businesses through portfolio management and operational excellence, while pursuing strategic partnerships and inorganic growth opportunities,” Prasad added.