Capitalstars Updates: Dr Reddy's receives unfavourable EIR for its Srikakulam plant: 26 Feb 2018

The company has launched gRenvela from this site while gCopaxone has also been filed from this site.

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.

The company in November 2015 received a warning letter for its two API facilities located at Miryalaguda and Srikakulam and a formulation facility at Duvvada. Of this, Miryalaguda API plant has been cleared after successful re-inspection, while Duvvada formulations and Srikakulam API facility remain under the warning letter.

In April 2017 re-inspection, API facility in Srikakulam received two observations by the US drug regulator. These observations were in the areas of high-performance liquid chromatography (‘HPLC’) maintenance and the management of soft copies of chromatograms. In the warning letter, USFDA had also found previously undisclosed quality-control lab at the facility.

This is a negative news on the counter.

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