US FDA wants improvement plan for Aurobindo’s unit

US FDA wants improvement plan for Aurobindo’s unit

Mumbai: Drugmaker Aurobindo Pharma said on Monday it has received a warning letter from the US FDA, based on a field alert report for packaging and labeling compliance for unit-III, seeking a detailed action plan for improvement.

Shares of Aurobindo Pharma extended fall to over 8% following the announcement.

The Hyderabad-based drugmaker had said in February, shipments from an Andhra Pradesh unit to the US market would be impacted after the US FDA imposed a ban on imports from the facility.

The detailed plan is required to be submitted within 15 working days, the drugmaker said in a statement.

“The impact of the US FDA has already been taken into account and fundamentals of the company remain strong," Siddhant Khandekar, analyst with ICICI Securities, said.

“Lower stock price is a good point entry point for investors." The affected unit ships products to the world’s top drugmaker Pfizer.

At 1:13 pm, shares of Aurobindo Pharma were trading at Rs176.70 down 8.61% in a weak Mumbai market.