Dr Reddy's receives FDA 483 at Indian API plant

By Dan Stanton contact

- Last updated on GMT

The US FDA has issued a Form 483 with four observations to an API facility in Hyderabad, India run by Dr Reddy’s Laboratories.

In a filing with the Bombay Stock Exchange, Indian drugmaker Dr Reddy’s said the US Food and Drug Administration (FDA) completed an audit at an active pharmaceutical ingredient (API) plant in Hyderabad in the Indian state of Telangana Friday.

“We have been issued a Form 483 with four observations which will be addressed comprehensively within stipulated time.”

A company spokesperson could comment neither on the APIs made at the plant nor the observations, beyond what was said to the exchange.

But "we believe that there will not be an delays in the current production,"​ we were told.

According to the firm, the Hyderabad site serves as the corporate centre for Dr. Reddy’s custom pharma services (CPS) business, and includes six commercial API production units, six pilot plants and two kilo labs, and over two million litres of reactor capacity.

The 483 is the latest regulatory action to hit Dr Reddy’s network. In 2017​, a Form 483 with three observations was sent to an API plant in Miryalaguda, Talangana.

Three other Dr Reddy run plants also received 483s last year. They were a finished dosage form site in Duvvada​​, an API plant in Srikakulam​​ and a generic drug facility in Bachupally​​.

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