Aurobindo Unit VII indicated for USFDA action

Aurobindo Pharma Ltd has said that the US FDA has lined up one of its oral solids formulation plants in Telangana for regulatory action, following adverse findings in an October inspection.

The company’s shares had fallen by 19% in intra-day trading on October 8, soon after the company disclosed that FDA inspectors had made seven observations in their inspection report.

FDA conducted a cGMP (current Good Manufacturing Practices) inspection at the Unit VII manufacturing facility from September 19-27 this year.

At the time, the company had said that it was confident of addressing the concerns. However, today, the company intimated investors that the US regulator has decided to recommend the plant for official action.

Shares of the company were down 5% in early trade today on the NSE at Rs 483.

Any adverse action on a particular plant by the US authorities could result in the company being prevented from exporting products from that plant to the US market.

The company, however, maintained that the action against Unit VII will not have any ‘material impact’ on the existing revenue or supplies to the US business ‘at this juncture’.

“The company will work closely with the regulator to comprehensively address the issues,” it added.

US inspectors had noted several shortfalls in their inspections last year.

“The responsibilities and procedures applicable to the quality control unit are not fully followed Several lists of documents requested were either provided as incomplete, inaccurate and or explained with potentially misleading statements through out the inspection,” said the FDA report.