USFDA Observations For Dr. Reddy’s
According to the drugmaker’s exchange filing, the US drug regulator had carried out an inspection between June 16 – June 25 at the Bachupally facility and concluded it with the issue of the form 483.This follows two prior inspections, one in October 2023, during which it had received nine observations and the other being in September 2025, during which the regulator had issued five observations to the facility.
Dr. Reddy’s Bachupally unit has two blocks, one is an older block, from which the biosimilar Rituximab was filed, and the other one is for the biosimilar abatacept.While Rituximab is a blood cancer treatment monoclonal antibody, Abatacept is a biological medication used in the modulation of the immune system to reduce inflammation.
Why Is Nomura Bullish on Dr. Reddy’s?
Brokerage firm Nomura maintained its “buy” rating on the stock with a price target of ₹1,740. The price target implies an upside potential of 29% from current levels.The brokerage said that most of the observations issued by the USFDA this time around relate to the new facility, and that the long-standing contamination concerns, with regards to an old block may have been addressed by the company.
Dr. Reddy’s has also expressed confidence in resolving the observations and remains optimistic of approvals and drug launches in the January-May stretch of 2028.
Shares of Dr. Reddy’s Laboratories are trading 4.6% higher on Monday at ₹1,413.1. The stock has gained 8.5% so far in the month of June, which has turned out to be its best month since December 2024, during which it had gained 15%.
