Eugia Pharma Specialities, a fully owned subsidiary of Aurobindo Pharma, has recently received a warning letter from the U.S. Food and Drug Administration (USFDA) concerning its formulation manufacturing facility. This facility, located in Hyderabad, has been under scrutiny by the USFDA and had previously been assigned the Official Action Indicated (OAI) status.
This designation indicates that the USFDA had identified serious compliance issues that needed addressing. Following the OAI status, the facility has now been issued a formal warning letter from the USFDA. Despite this development, Aurobindo Pharma has assured stakeholders that there will be no disruption to its current supply chain for the U.S. markets.
The company stated that it remains dedicated to working closely with the USFDA to address any concerns and is committed to improving its compliance practices continually. In a statement provided to the Bombay Stock Exchange (BSE) on Friday, Aurobindo Pharma emphasized its ongoing efforts to enhance regulatory adherence and its resolve to resolve the issues highlighted by the USFDA.
The company’s focus is to rectify the identified issues promptly and to ensure that its manufacturing operations meet the stringent requirements set forth by the USFDA. Following the news, Aurobindo Pharma’s stock experienced a decline of 1.91 percent on the BSE. As of noon on Friday, the company’s shares were trading at ₹1,490.20.
The market reaction reflects investor concern over the regulatory challenges faced by the company, despite assurances of no immediate impact on existing product supplies to the U.S. market. Aurobindo Pharma remains committed to restoring and maintaining its reputation for quality and compliance in its manufacturing practices.
Eugia Pharma Specialities is a leading pharmaceutical company based in Hyderabad, India. It specializes in the development and manufacturing of high-quality formulations across various therapeutic segments. Eugia Pharma is committed to maintaining stringent compliance with global regulatory standards and delivering innovative, effective, and affordable healthcare solutions.
