Aurobindo Pharma clarifies on US FDA inspection reports; stock recovers 3% from day’s low

Shares of Aurobindo Pharma declined in Wednesday’s trade, dropping over 4 per cent following reports of lapses observed made by the US drug regulator, the US Food and Drug Administration (US FDA). But counter staged some recovery after the hyderabad-based drugmaker clarified regarding media reports around its Unit-VII manufacturing facility.

The decline comes after media reports of specific details of a Form 483 issued to the drugmaker's Unit-VII facility, which included flags for data integrity and hygiene.

Aurobindo Pharma informed exchanges with a clarification to the NDTV Profit report. “At present, there is no material event or information that requires further disclosure under Regulation 30 of the SEBI LODR Regulations, other than what has already been disclosed to the exchanges,” the company said.

The pharma major said that any observations issued during such inspections are addressed in accordance with established regulatory processes.

After hitting day’s low of Rs 1,130, the stock pared some losses. At 2:32 pm, the Aurobindo counter was trading at Rs 1,162.25 on the BSE, a recovery of nearly 2.8 per cent from the day’s low level, though it still lingered about 1.5 per cent in the red.

Aurobindo Pharma, in its regulatory filing on February 10, said that all observations are procedural in nature. The company stated it would respond to the US FDA within the stipulated timelines and asserted that there is no impact on the company's financials or operations due to the said action.

The Unit-VII facility is located in the Green Industrial Park in Jedcherla Mandal, Mahaboobnagar District, Telangana.