Dr Reddy’s prepares for Duvvada re-inspection following Form 483
The Indian drugmaker has attracted regulatory attention from the US Food and Drug Administration (FDA) over the past few years for its Duvvada and Srikakulam facilities.
The agency issued Dr Reddy’s Duvvada facility – which formulates cancer drugs – a Form 483 with 13 observations in March last year.
The company also received an FDA warning letter for the site in 2015.
Earlier this week, CEO GV Prasad told investors the firm has done a “lot of work on remediation over the last 12 months” at its Duvvada facility in Vishakapatnam, India.
“We expect to go back to the FDA end of June and request a re-inspection,” he added, highlighting that the re-inspection may not be conducted immediately.
Srikakulam API plant update
Dr. Reddy’s is also addressing good manufacturing practice (GMP) issues at its Srikakulam active pharmaceutical ingredient (API) plant.
In November 2014, the facility – located in India’s southeastern state of Andhra Pradesh – received an FDA Form 483 with nine observations about the plant’s procedures.
In November 2015, the site received a warning letter from the US regulator.
“We are not yet clear whether [the Srikakulam facility] will require a re-inspection because the inspection that happened was fairly straight-forward,” said Prasad.
The company expects to have addressed all concerns within the next six weeks, he told investors.
“After that, we will have to ask the FDA what the next step should be,” he added.
