Is US FDA nod in sight for Aurobindo's troubled Unit III?
Aurobindo Pharma was among several pharmaceutical companies around the World to receive US Food and Drugs Administration (FDA) approval to sell a generic version of AstraZeneca's Seroquel, a drug used to treat mental disorders like schizophrenia, on Wednesday.
March 29, 2012 / 22:06 IST
Aurobindo Pharma was among several pharmaceutical companies around the World to receive US Food and Drugs Administration (FDA) approval to sell a generic version of AstraZeneca's Seroquel, a drug used to treat mental disorders like schizophrenia, on Wednesday.
But what's crucial for Aurobindo is that the drug approval comes from its troubled unit III, which could probably mean US FDA clearance may be in sight for the troubled unit.The company's unit III had received a warning letter from US FDA in May 2011 and clearances for products from that unit were stuck for the last nine months, points out CNBC-TV18.Aurobindo Pharma told the TV channel on Thursday that this copy of Seroquel is the first product approval flowing in post US FDA inspection of the unit in March this year.It said supplies from unit III were not affected for the US market, but approvals for products under review were held back. It is still awaiting formal communication from US FDA on the matter.Aurobindo Pharma has filed 123 products from Unit III. Meanwhile Aurobindo's manufacturing VI is still under import alert from US FDA.The company said it is in the process of taking exhibit batches from Unit VI and will invite US FDA for inspection of the unit with revalidated data submissions.Aurobindo Pharma shares on Thursday closed up 0.5% at Rs 115.50 on NSE.
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