Dr Reddy’s has announced that the company has received an unfavorable Established Inspection Report (EIR) for its API facility in Srikakulam. The EIR mentions of OAI (official action indicated) meaning that company will have to provide more details to the USFDA. This means that the plant will continue to remain under the warning letter and one has to see the next course of the action by USFDA. The OAI is issued when there are objectionable conditions found at the manufacturing facility.The company has indicated that the company continues to market drugs in the US markets despite the warning letter, however, it has implications for the future drug approvals. Srikakulam plant has two dosages i.e. oral solid and topicals. The company has launched gRenvela from this site while gCopaxone has also been filed from this site.
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