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Warning letter woes: Dr Reddy's expects FDA inspection of AP


Press Trust of India Hyderabad
Dr Reddy's Laboratories was expecting an inspection of its Active Pharmaceuticals Ingredients (API) plant at Srikakulam in Andhra Pradesh by the US Food and Drug Administration officials by the end of this year, a top company official said on Tuesday.
"On the regulatory front, the API plant at Miryalaguda was given an Establishment Inspection Report (EIR) in 2017 resolving the earlier warning letter. We also received EIR for the injectable site at the Duvvada and we are awaiting for CTO VI site at Srikakulam.
And based on discussions, we expect an inspection ( by the FDA) later this year and hopeful for the resolution of the matter," Co-Chairman, Managing Director and CEO GV Prasad told shareholder in the Annual General Meeting held here.
The USFDA had issued warning letter in November 2015 relating to Current Good Manufacturing Practice (CGMP) deviations at DR Reddy's API manufacturing facilities at Srikakulam in AP and Miryalaguda in Telangana besides its oncology formulation facility at Duvvada, Visakhapatnam.
Regarding the API plant at Miryalaguda, the USFDA reinspected in January 2019, for which the USFDA issued an EIR in May, 2019.
Similarly, in February 2019, the USFDA issued an EIR for the oncology formulations facility at Duvvada and has determined the inspection classification of this facility as Voluntary Action Initiated (VAI).
"In March 2019, we responded to the follow-up questions from USFDA regarding the API facility in Srikakulam.
Based on the subsequent discussion with USFDA, we expect a re-inspection to be conducted for the site," Dr Reddy's said in its latest annual report.
On the pharma industry, Prasad said major players across the world were in turmoil and drug manufacturing companies were under significant pressure because of the pricing environment in the USA.
According to him, there is also a disruption in the emerging markets as well as new opportunities in China.
"Healthcare systems around the world are facing huge cost pressures. We believe that these difficult industry situations which look like threats to our industry actually be huge opportunity for focused and efficient players," he said.
He said going forward, Dr Reddy's chalked out three themes for implementation- building strengths in its core businesses of API and generics, streamlining biosimilars and proprietary product business to accelerate their path to profitability and continence of operational excellence across various functions to build world world class competitiveness.

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First Published: Jul 30 2019 | 1:35 PM IST

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