A June inspection now has the FDA hitting Dr. Reddy’s with a Form 483, with seven observations spotted at its Indian biologics plant in Hyderabad during a site visit that wrapped up this week.
The agency conducted its visit from June 16 through June 25, Dr. Reddy’s explained in a Thursday disclosure (PDF) on the Bombay Stock Exchange. The company did not specify the nature of the seven observations flagged by the FDA, but pledged to address the Form 483 “within the stipulated timeline.”
Dr. Reddy’s also pointed to earlier FDA inspections at the site in October 2023 and September 2025. In September, the FDA spotted five manufacturing deficiencies at the plant, resulting in a Form 483 after an inspection that same month.
The drug manufacturer noted in its BSE filing that the latest action "is also in continuation of the earlier inspections and corresponding disclosures."
The company’s spread of India-based plants has been on the receiving end of many similar FDA reprimands over the years. In early 2024, the agency flagged three observations at Dr. Reddy’s Bachupally R&D campus after a December 2023 inspection. Those concerns centered on deficient record-keeping procedures, a lack of detailed technical control procedures for reviewing technical data and lackluster employee training, with one staffer “overdue” on a required training procedure for more than two years.
Also in 2024, Dr. Reddy’s API plant in Pydibhimavaram, Andhra Prades, India received a Form 483 with four observations directed mainly at the site’s quality control unit, including incidents that showed a lack of proper testing and follow-up after producing API batches. Another FDA inspection at its Duvvada, Visakhapatnam, formulation manufacturing facilities saw the company cited with two observations that year as well.
Still, despite the history of FDA observations, Dr. Reddy’s and its generic portfolio is steadily expanding as of late.
Earlier this month, the company launched the first generic to Pfizer’s chronic myeloid leukemia med Bosulif in the U.S. after partnering with MSN Laboratories on development and manufacturing. The rollout “highlights our commitment to leading with timely market entry for high-priority therapies while broadening access for both patients and healthcare providers,” Dr. Reddy’s CEO, North America, Milan Kalawadia commented at the time.
Bosulif earned some $253.8 million for Pfizer over the last 12 months, according to Dr. Reddy’s. Meanwhile, the company is getting in on what could be a much bigger sales driver with its generic versions of Novo Nordisk’s GLP-1 semaglutide for diabetes.
Last month, Dr. Reddy’s launched its generic semaglutide injections in Canada as the first company to score approval of the generic from Health Canada. Shortly after that, the company hopped on the oral GLP-1 wave with its oral semaglutide biosimilar Obeda taking off in India, establishing Dr. Reddy’s as a “full-stack player in GLP-1 therapies,” it said at the time.
Both generics are only indicated for type 2 diabetes, as opposed to the obesity indications that Novo’s Wegovy and Wegovy pill semaglutide products hold.