Feb 24, 2011, 06.01 PM IST

Aurobindo sends report to USFDA on detention of drugs

Aurobindo Pharma has clarified on United States Food and Drug Administration (USFDA) import alert for detention of Unit VI products. The drug firm has said that its Unit VI Cephalosporin facility in Andhra Pradesh, India was audited by USFDA in December last year.

Source: Moneycontrol.com
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Aurobindo sends report to USFDA on detention of drugs
Aurobindo Pharma has clarified on United States Food and Drug Administration's (USFDA) import alert for detention of Unit VI products. The drug firm has said that its Unit VI Cephalosporin facility in Andhra Pradesh, India was audited by USFDA in December last year.


Subsequent to the audit findings, USFDA had imposed an import alert on their website for detention on Aurobindo's Unit VI products. However, Aurobindo Pharma has sent the compliance report to USFDA, which is currently under review.


The company is trying to establish contact with USFDA to understand the correct interpretation of such an alert on whether it relates only to sterile products or oral products manufactured at Unit VI.


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