Once we understand USFDA concerns, would support Aurobindo: Pfizer

Pfizer, which has a tie up with city-based Aurobindo Pharma Ltd (APL) on generic supplies, on Thursday said it would extend support to the Indian company once it understands the issues related to the USFDA import ban alert.

“Once we understand FDA’s concerns, we will work with Aurobindo to assist with next steps,” Pfizer spokesperson told PTI.

Aurobindo Pharma had recently found an import alert in USFDA Web site on products manufactured at their Cephalosporin facility, Unit VI at Chitkul Village near Hyderabad. The officials of USFDA had audited the facility in December last year and the company has sent the compliance report to USFDA, which is under review.

“Subsequent to the audit findings, USFDA has imposed an import alert on their Web site for detention on APL Unit VI products,” the alert read.

Pfizer confirmed four of its injectable products —— Cefazolin, Cefotaxime, Ceftazidime and Ceftriaxone —— are affected by this import alert.

It however said, “Most products manufactured by Aurobindo and sold by Pfizer are made at other Aurobindo production units and are not impacted by the import alert.”

Pfizer, had entered into a large supply contract with the Hyderabad firm in 2009. As per the strategic alliance entered, Pfizer acquired rights to 55 oral dose products and five sterile injectable products of Aurobindo for patients in more than 70 emerging markets including the US and some European countries.

Aurobindo had earlier said they will suffer a revenue loss to the extent of $2 million a month as long as the issue remains unresolved.

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