Shares of Aurobindo Pharma, an Indian pharmaceutical company, fell over 1% on Friday after the US Food and Drug Administration (FDA) discovered multiple faults at the company’s Anakapalli facility. According to a report obtained by Bloomberg News, FDA auditors found deficient controls for manufacturing equipment cleaning and storage during a visit to the facility in eastern India last month.
The FDA report highlighted the lack of proper cleaning and maintenance of sampling tools at the plant, which produces active pharmaceutical ingredients (API). Additionally, the report mentioned that the laboratory controls did not meet specifications needed to ensure drug products conform to the required standards of quality, identity, and purity.
This is not the first time the FDA has raised concerns about the Anakapalli facility. Aurobindo Pharma reported procedural observations from the FDA following an inspection in May. The Anakapalli plant is responsible for manufacturing APIs used in cardiovascular and anti-fungal treatments.
In a separate filing on June 29, Aurobindo Pharma disclosed that its subsidiary Auro PR Inc, based in Puerto Rico, is undergoing facility restructuring to increase production volume. The company stated that Auro PR Inc will not conduct any manufacturing activity until the repairs and restructuring are complete. Auro PR Inc contributed 1.76% of Aurobindo Pharma’s consolidated turnover in the previous year.
Despite the recent share price decline, Aurobindo Pharma’s stock has seen a significant increase of over 67% this year. As of 10:55 am, the company’s shares were trading at ₹726.75 apiece on the Bombay Stock Exchange.
It is important to note that Aurobindo Pharma is not the only pharmaceutical company to face scrutiny from regulatory authorities. The FDA conducts regular inspections to ensure compliance with manufacturing standards and quality control measures. Such inspections and subsequent observations help identify areas for improvement and ensure the safety and efficacy of pharmaceutical products.
The findings of the FDA inspection raise concerns about the manufacturing practices at Aurobindo Pharma’s Anakapalli facility. The company will need to address these issues and implement the necessary corrective measures to regain the confidence of regulatory authorities and investors alike. Continued non-compliance with regulatory requirements could lead to further consequences for Aurobindo Pharma, potentially impacting its reputation and financial performance.
It is crucial for pharmaceutical companies to prioritize and maintain high manufacturing standards to ensure the quality and safety of their products. Regulatory compliance is essential for gaining and retaining the trust of consumers, healthcare professionals, and regulatory agencies.
Disclaimer: The information in this article is for informational purposes only and should not be considered as financial or investment advice.
