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USFDA lifts import alert imposed on Aurobindo Pharma’s Unit-VI in Hyderabad

28 Mar 2013 Evaluate

USFDA has lifted the import alert for non-sterile products manufactured in Aurobindo Pharma‘s Unit-VI cephalosporin facility based in Hyderabad, India, thereby paving the way for resumption of exports of 9 products to the US market. The import alert was imposed earlier in February 2011. Prior to import alert, the Unit was having annual US sales of $ 33 million for the products.

Aurobindo Pharma, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.

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