Aurobindo to suffer USD 2-mn loss per month due to USFDA ban

Written by: Pti
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Hyderabad, Feb 24 (PTI) Aurobindo Pharma Limited, whichhas suffered a setback in exports to USA after USFDA''s importban alert on products manufactured at Cephalosporin facilityof APL at Chitkul village near here, said they may incur arevenue loss to the extent of USD 2 million per month till theissue remains unresolved.

"Our sales may be affected by USD 2 million per month aslong as this issue is not resolved. This is common for anypharma company. We cannot predict how long it will take (toresolve the issue). It may take some time. As per ourtechnical advisor''s estimations we can say it may take someweeks to resolve the issue," APL Managing Director, NityanandaReddy told PTI.

He said the products from this unit which are undertransit will also be affected with the directive of USregulator. According to Reddy, they have not received anyofficial communication from the United States Food and DrugAdministration (USFDA) in this regard.

The officials of USFDA audited the facility in Decemberlast year and the company has sent the compliance report toUSFDA, which is under review.

"Subsequent to the audit findings USFDA has imposed animport alert on their website for detention on APL Unit VIproducts," the alert said, on February 7.

APL is trying to establish contact with USFDA tounderstand the correct interpretation of such an alert onwhether it relates only to sterile products and/or oralproducts manufactured at Unit VI, the company said. (MORE) PTIGDK DK

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