The Indian drugmaker received the warning letter for Unit XI of its API manufacturing facility at Srikakulam district in southern state of Andhra Pradesh, according to a statement on exchanges.
- Says the warning letter comes after an inspection of the site by the drug regulator in February
- Aurobindo will engage with the U.S. regulator and is “fully committed in resolving this issue at the earliest”
- “We believe the existing business from this facility will not be impacted,” Aurobindo Pharma says in statement
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