Dr Reddy’s prepares for Duvvada re-inspection following Form 483

By Flora Southey contact

- Last updated on GMT

Dr Reddy’s expects to have addressed all GMP violations at its Duvvada drug formulation plant and Srikakulam API facility within the next six weeks, says CEO.

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.

Related news

Show more

Related products

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Lactium, your ally to manage day to day stress

Lactium, your ally to manage day to day stress

Ingredia | 27-Aug-2020 | Product Presentation

Stress has been called the ‘health epidemic of the 21st century’ by the World Health Organization. Increasingly, consumers are looking for safe, reliable...

Related suppliers

Follow us


View more