Aurobindo Pharma had received letters from the US health regulator, saying inspections concluded in February revealed significant objectionable conditions or practices and action must be taken to address the issues.
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Aurobindo Pharma shares slumped nearly 8% in intraday trade on Friday after the company said it has received a warning letter from the US Food and Drug Administration (FDA) for its plant in Andhra Pradesh.
The warning letter relates to the Unit XI of API (active pharmaceutical ingredient) manufacturing facility at Srikakulam district in Andhra Pradesh. This action follows the earlier inspection of the site by the FDA in February 2019, the company added.
At 1:32pm, the company’s shares were trading at Rs 596.10, down 5%, at BSE. The stock has lost 24% in the last three months.
The pharma giant believes the existing business from this facility is not going to be impacted. “We will be engaging with the regulator and are fully committed to resolving this issue at the earliest,” it said in exchange filings.
The company also reiterated its commitment to maintaining the highest quality manufacturing standards at all of its facilities across the globe.
The agency had said that the laboratory records at Bachupally, Telangana do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
On May 17, Aurobindo Pharma had received letters from the US health regulator, classifying the inspections concluded in February 2019 at API facilities of unit XI, along with unit I and intermediates facility of unit IX, as Official Action Indicated (OAI).
OAI means an FDA inspection revealed significant objectionable conditions or practices and action must be taken to address the issues. It also indicates that approvals of pending applications or supplements from the site maybe withheld.
Source: News18