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Aurobindo Pharma Ltd is expecting an ‘early' inspection by US Food and Drug Administration on its Unit IV here to revoke the ban imposed.
In February, the US drug regulator had banned the imports of products manufactured from the unit IV of its manufacturing facility on the outskirts of Hyderabad, following an inspection it had conducted in December 2010.
“The US consultants hired by us for the purpose are already talking to them. We hope for an `early inspection of the facility,” a senior functionary of the Hyderabad-based company told Business Line here on Saturday.
Products
Aurobindo is manufacturing Cephalosporin oral and injectable products at the unit.
On the impact of ban on the financial performance of the company during 2010-11, he said it was not ‘significant' as it had happened towards the end of the financial year.
Aurobindo's net profit for FY11 was flat at Rs 563 crore on a total revenue of Rs 4,481 crore.
Strategy
The company is in the process of `minimising' the impact of the ban in the present financial year as well.
“The annual revenue from the unit (for Cephalosporin products) is about Rs 120 crore. Even if the ban on the unit is not revoked during FY12, we expect positive growth this year,” he said.
Aurobindo has lined up three-four products on non-Cephalosporin segments which would bring ‘good' revenue, he added.
ANDA
During 2010-11, 21 new Abbreviated New Drug Applications (ANDAs) of the company were approved by the USFDA.
Further, the ban is only applicable to the US and the products of the unit IV could be exported to other regions, he added.
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