Stock to watch: Dr. Reddy's gets two observations from USFDA

Shares of Dr. Reddy's Laboratories are in news today after the pharma firm reported on May 17, 2025, that the US health regulator issued a Form 483 with two observations following an inspection of its facility in the U.S. The inspection by the U.S. Food and Drug Administration (FDA) focused on the company's active pharmaceutical ingredients (API) facility located in Middleburgh, New York, as stated in a regulatory filing.

The inspection took place from May 12 to May 16, 2025.

The Hyderabad-based company noted, "We have received a Form 483 with two observations, which we will address within the specified timeline."

According to the FDA, a Form 483 is provided to a company's management at the end of an inspection when the investigator identifies any conditions that may represent violations of the Food, Drug, and Cosmetic (FD&C) Act and related regulations.

The company reported a 22% year-on-year rise in consolidated net profit, reaching Rs 1,594 crore.

The board of the firm recommended a final dividend of Rs. 8/- per equity share of Rs. 1/- each for the financial year
2024-25.

Revenue figures also outperformed predictions, totaling Rs 8,506 crore compared to Rs 7,083 crore during the same period last year, reflecting a growth of 20%.

Commenting on the results, Co-Chairman & MD, G V Prasad said: "We achieved double-digit growth across our businesses, driven by successful product launches, increased revenues from key products in the U.S. and the integration of the acquired NRT business. We will continue to strengthen and grow our core businesses through portfolio management and operational excellence, while pursuing strategic partnerships and inorganic growth opportunities."