Aurobindo Pharma Facility Receives US FDA’s ‘Official Action Indicated’ Classification

Aurobindo Pharma Ltd. announced that the US Food and Drug Administration (FDA) has classified its Unit II formulation manufacturing facility, operated by Eugia Pharma Specialities, as ‘Official Action Indicated’ (OAI) following an inspection. The inspection took place from April 25 to May 3, 2024, at the Bhiwadi facility in Alwar, Rajasthan.

Implications of OAI Classification

The OAI classification indicates that the US FDA has identified issues at the facility that require corrective action before it can resume normal operations or obtain new product approvals. The classification signifies that regulatory and administrative actions are recommended to address the identified concerns.

Aurobindo Pharma’s Response

In response to the classification, Aurobindo Pharma has committed to working closely with the US FDA to address the concerns raised. The company stated that it continues to enhance its compliance practices on an ongoing basis to meet regulatory standards.

Impact on Shares

Following the announcement, shares of Aurobindo Pharma fell by 1.71% to Rs 1,418.55 apiece on the NSE, compared to a 2.68% decline in the benchmark Nifty.

Company Profile

Aurobindo Pharma Limited, headquartered in Hyderabad, India, is an integrated global pharmaceutical company. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients (APIs) globally in over 150 countries. Aurobindo Pharma operates 25 manufacturing and packaging facilities approved by leading regulatory agencies, including the US FDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA.

Product Portfolio

The company’s product portfolio spans seven major therapeutic areas: CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic. This diverse portfolio is supported by a good R&D setup.

Conclusion

Aurobindo Pharma is now sticking to regulatory compliance and working on its response to the US FDA’s OAI classification. The company remains focused on addressing the identified issues and boosting its compliance practices to maintain its position as a leading global pharmaceutical manufacturer.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.