FDA observations on Telangana plant a fresh headache for Aurobindo Pharma

The Telangana unit in question is an important one contributing about a fifth to US revenues

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The Street’s confidence in the Aurobindo Pharma stock took a beating after it received unfavourable observations for one of its formulation units by the US drug regulator (the US Food and Drug Administration, or the USFDA). The stock slipped to its single largest daily loss, shedding more than 19 per cent on Monday. The USFDA has issued seven observations after its recent inspections at the company’s Unit VII facility in Telangana. The unit — an oral dosage facility — remains important for Aurobindo; it has the largest number of abbreviated new drug approvals ...