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Dr Reddy’s Receives 11 Observations For Hyderabad Facility By US FDA

The US FDA has issued Form 483 with 11 observations for Dr. Reddy’s Laboratories’ manufacturing facility in Hyderabad. Earlier on April 28, 2017, Dr. Reddy’s Bachupally manufacturing plant had received 11 USFDA observations. According to the company, these observations are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems. The company expects a pick-up in launches over the next few quarters (not dependent on facilities under the Warning Letter) including some complex approvals in FY20. Growth recovery in the US coupled with the benefit from cost optimization efforts should improve the earnings trajectory over the medium-term.

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