Aurobindo Pharma has informed the stock exchanges that Unit-I, a formulation manufacturing facility of Eugia Pharma Specialities, a wholly owned subsidiary of the company, has received a warning letter from the US Food and Drug Administration (FDA).
The development follows the facility receiving an Official Action Indicated (OAI) classification from the US FDA in May 2026.
“Subsequent to OAI, the unit has received a warning letter,” Aurobindo Pharma said in a stock exchange filing on Friday.
The US FDA conducts inspections of regulated facilities to assess compliance with applicable laws and regulations, including the Federal Food, Drug, and Cosmetic Act. Following an inspection, the agency assigns a final classification to the facility. An OAI classification indicates that a facility is in “an unacceptable state of compliance” and may result in regulatory action.
Aurobindo Pharma said the warning letter will have no impact on existing supplies to the US market. Unit-I of Eugia Pharma Specialities contributes approximately 2% of the Aurobindo Pharma Group’s overall revenue.
“The company remains committed to working closely with the US FDA and continues to enhance its compliance on an ongoing basis,” the company said, adding that it will keep the stock exchanges informed of further developments.
Eugia Pharma Specialities is Aurobindo Pharma’s fully integrated subsidiary focused on general injectables and oncology products. Its portfolio includes a range of injectable products like Penems, Penicillin, Cephalosporin, along with ophthalmic, inhalation (Respules), oncology, and hormone products.
The company operates globally with facilities in the US, Europe, Brazil, Mexico, Canada, Colombia, Australia and New Zealand, and select other markets.
Eugia Pharma Specialities currently has four fully commercialised manufacturing facilities, with another facility under development.
